Centric Health Closes Two Significant Transactions on the Heels of Strong Third Quarter Results11/25/2019 This morning, Centric Health Corporation (TSX: CHH), announced the successful closing of two previously announced transactions --- a private placement of common shares and convertible debentures, and the sale of its Surgical and Medical Centres business --- bringing in aggregate gross proceeds of $70.24 million. The closing of these transactions comes just over two weeks after the company announced strong third quarter results highlighted by revenue growth of 12.4% and adjusted EBITDA growth of 204.1% in their Specialty Pharmacy business. Centric Health sold its Surgical and Medical Centres business to Clearpoint Health Network Inc. for gross proceeds of $35 million. Centric Health announced last year that it was focusing on the seniors healthcare market in Canada, primarily on institutional pharmacy operations.
The company raised gross proceeds of $35.24 million through the private placement of common shares and convertible debentures. Pursuant to the private placement, the company issued 64,500,000 common shares at $0.12 per share for gross proceeds of $7.74 million and 8.25% unsecured debentures convertible into common shares in the aggregate principal amount of $27.5 million. The investors in the private placement included Yorkville Asset Management Inc. for and on behalf of certain managed funds (“Yorkville”), and certain existing major shareholders of the Company, including Ewing Morris & Co. Investment Partners Ltd., for and on behalf of certain funds and accounts managed by it ( “Ewing Morris”) and Dr. Jack Shevel and certain entities over which Dr. Shevel exercises control or direction, together with certain related parties and joint actors (“Dr. Shevel”), and the company’s President and Chief Executive Officer, David Murphy. Contemporaneously with the closing of the private placement, the company also exchanged 30,000,000 convertible preferred shares of the company for $12.54 million of 8% unsecured convertible debentures held by Ewing Morris. The net proceeds from both transactions are expected to be used to reduce bank debt and for working capital purposes.
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Akumin Inc. (TSX: AKU, AKU.U) ("Akumin" or the "Corporation") announced today its financial results for the quarter ended September 30, 2019 ("Q3 Fiscal 2019").
Commenting on the Q3 Fiscal 2019 financial results, Riadh Zine, President and Chief Executive Officer of the Corporation, said, "The quarter ending September 30, 2019 represents another fiscal quarter of growth and financial performance in-line with management's expectation, including revenue of $68.9 million and Adjusted EBITDA of $18.0 million. "Akumin's volume in Q3 Fiscal 2019 was approximately 1,435,000 RVUs, compared to approximately 850,000 RVUs in Q3 Fiscal 2018, an increase of 69%. On an organic volume basis, RVUs increased by 10% compared to Q3 Fiscal 2018. The Corporation reports the volume of procedures performed in its diagnostic imaging centers based on relative-value units, or RVUs, instead of the number of procedures. RVUs are a standardized measure of value used in the U.S. Medicare reimbursement formula for physician services which provides weighting to distinguish the complexity of different procedures. "Q3 Fiscal 2019 includes partial contribution of the recently announced acquisition in El Paso, Texas, completed on August 16, 2019. In early October 2019, the Corporation also completed a tuck-in acquisition in West Palm Beach, Florida, which is not reflected in the quarter." Akumin would like to remind interested parties of the Corporation's Third Quarter Fiscal 2019 Financial Results Call, to be held today from 8:30 a.m. to 9:00 a.m. Eastern Time. To access the conference call, dial toll-free in Canada or the U.S. 888-231-8191 or, for international callers, 647-427-7450. A related presentation will be available for download on Akumin's website at https://akum.in/Q3-presentation. Participants are asked to connect at least 10 minutes prior to the beginning of the call to ensure participation. The Corporation has retained the services of Hinge Markets Inc., led by Jeffrey White, to provide investor relations services and to increase awareness of the Corporation and its activities with its existing and potential shareholders. Mr. White, founder of Hinge Markets Inc., and a lawyer by training, has spent more than 20 years in the capital markets as a professional and a senior executive in both corporate finance and institutional equity sales. Unless otherwise indicated, all amounts are expressed in U.S. dollars. Certain metrics, including those expressed on an adjusted or comparable basis, are non-IFRS measures. See "Non-IFRS Measures" and "Selected Consolidated Financial Information" of this press release for further details. The Corporation's consolidated financial statements for Fiscal 2018 and related management's discussion and analysis are available under Akumin's profile on SEDAR (www.sedar.com). About Akumin Akumin is a leading provider of freestanding, fixed-site outpatient diagnostic imaging services in the United States with a network of owned and/or operated imaging centers located in Florida, Texas, Pennsylvania, Delaware, Illinois, Kansas and Georgia. By combining our clinical expertise with the latest advances in technology and information systems, our centers provide physicians with imaging capabilities to facilitate the diagnosis and treatment of diseases and disorders and may reduce unnecessary invasive procedures, minimizing the cost and amount of care for patients. Our imaging procedures include MRI, CT, positron emission tomography (PET), ultrasound, diagnostic radiology (X-ray), mammography, and other interventional procedures. Non-IFRS Measures This press release makes reference to certain non-IFRS measures. These non-IFRS measures are not recognized measures under the International Financial Reporting Standards ("IFRS") and do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Rather, these non-IFRS measures are provided as additional information to complement those IFRS measures by providing further understanding of our results of operations from management's perspective. Accordingly, these non-IFRS measures should not be considered in isolation nor as a substitute for analysis of our financial information reported under IFRS. We use non-IFRS financial measures, including "EBITDA", "Adjusted EBITDA", "Adjusted EBITDA Margin" , "Adjusted net income (loss) attributable to shareholders of Akumin" and "Adjusted EPS – Diluted". These non-IFRS measures are used to provide investors with supplemental measures of our operating performance and thus highlight trends in our core business that may not otherwise be apparent when relying solely on IFRS measures. We also believe that securities analysts, investors and other interested parties frequently use non-IFRS measures in the evaluation of issuers. Our management uses non-IFRS measures in order to facilitate operating performance comparisons from period to period, to prepare annual operating budgets and forecasts, and to determine components of management compensation. Definitions and reconciliations of non-IFRS measures to the relevant reported measures can be found in our Management's Discussion and Analysis dated November 13, 2019 available at www.sedar.com. We define such non-IFRS measures as follows: "EBITDA" means net income (loss) attributable to shareholders of the Corporation before interest expense (net), income tax expense (recovery) and depreciation and amortization. "Adjusted EBITDA" means EBITDA, as further adjusted for stock-based compensation, impairment of property and equipment, provisions for certain credit losses, settlement costs, provisions, acquisition-related and public offering costs, gains (losses) in the period, one-time adjustments and IFRS 16 impact on leases. "Adjusted EBITDA Margin" means Adjusted EBITDA divided by the revenue in the period. "Adjusted net income (loss) attributable to shareholders of Akumin" means Adjusted EBITDA less depreciation and amortization and interest expense (excluding IFRS 16 impact on depreciation and interest expense), taxed at Akumin's estimated effective tax rate, which is a blend of U.S. federal and state statutory tax rates for Akumin for the period. Source: Akumin Inc. Centric Health Corporation (“Centric Health” or “the Company”) (TSX: CHH), one of Canada’s leading healthcare services companies, reported its financial results for the third quarter ended September 30, 2019.
Highlights for the Third Quarter
“Our momentum continued in the third quarter, with strong growth in revenue and beds serviced, and significant growth in Adjusted EBITDA for our core Specialty Pharmacy business,” said David Murphy, President and Chief Executive Officer of Centric Health. “The quarter was also an eventful and successful one as it relates to strengthening our balance sheet, as we announced both the sale of our Surgical and Medical Centres division and a large private placement. With these milestones and our strategic transformation substantially completed, we have significantly improved our ability to capitalize on organic growth and acquisition opportunities in the Canadian institutional pharmacy sector.” FINANCIAL RESULTS Revenue from Specialty Pharmacy for the third quarter increased 12.4% to $31.4 million compared to the same period in the prior year as a result of continued growth in the average number of beds serviced during the quarter and the impact of revenue initiatives from the 2018 Business Re-Engineering Plan. Adjusted EBITDA from Specialty Pharmacy increased 204.1% to $4.0 million for the third quarter compared to the same period in the prior year. The increase was due to higher revenue, the impact of the Business Re-Engineering Plan, and operational efficiencies resulting from increased scale as a higher average number of beds were serviced compared to the prior period. The impact of IFRS 16 for the quarter was an increase to Adjusted EBITDA from Specialty Pharmacy of $0.5 million. Adjusted EBITDA margin from Specialty Pharmacy was 12.9% for the quarter (11.3% excluding the impact of IFRS 16). The Company’s 2019 financial results include the impact of IFRS 16, a substantial change to lease accounting standards, effective January 1, 2019. Centric Health adopted IFRS 16 using the modified retrospective approach and the Company’s comparative information was not restated. As a result, the comparability of the Company's 2019 Adjusted EBITDA to periods prior to January 1, 2019 is impacted. Corporate office expenses were lower for the quarter by 10.1% at $1.2 million compared to the same period in the prior year, with the variance being primarily due to labour savings realized in the current year. Adjusted EBITDA from continuing operations was $2.8 million for the third quarter compared to a loss of $42 thousand for the same period in the prior year. The overall impact to Adjusted EBITDA from continuing operations from the adoption of IFRS 16 was an increase of $0.5 million for the quarter. DISCONTINUED OPERATIONS During the three and nine month periods ended September 30, 2019, the Company disposed of the operating assets of its retail pharmacy operations in Grande Prairie, AB and Medicine Hat, AB. The results of these operations have been included as part of discontinued operations on the consolidated statement of income and comprehensive income. As required under IFRS, the Company classified its former Surgical and Medical Centres segment as assets held for sale and have presented its current and prior year results as discontinued operations. Revenue and Adjusted EBITDA from discontinued operations were $8.9 million and a loss of $0.1 million, for the third quarter, respectively. The impact of the transition to IFRS 16 in discontinued operations was an increase to Adjusted EBITDA of $0.4 million for the quarter. For further information, please refer to the Company’s complete filings at www.sedar.com. ABOUT CENTRIC HEALTH Centric Health's vision is to be the leading provider of pharmacy and other healthcare services to Canadian seniors. The Company is one of Canada's leading, and most trusted providers of comprehensive Specialty Pharmacy services and solutions to seniors. We operate a large national network of pharmacy fulfilment centres that deliver high-volume solutions for the cost-effective supply of chronic medication and other specialty clinical pharmacy services, serving more than 31,000 residents in over 460 seniors communities (long-term care, retirement homes, and assisted living facilities) nationally. With services that address the growing demand within the Canadian healthcare system, Centric Health's unparalleled national care delivery platform provides significant potential for future expansion and growth. FORWARD-LOOKING STATEMENTS This press release contains statements that may constitute "forward-looking statements" within the meaning of applicable Canadian securities legislation. These forward-looking statements include, among others, statements regarding the Company’s business strategy, plans and other expectations, beliefs, goals, objectives, information and statements about possible future events. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate” or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include the Company’s liquidity and capital requirements, government regulation and funding, the highly competitive nature of the Company’s industry, reliance on contracts with key customers and other risk factors described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on the Company's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The factors underlying current expectations are dynamic and subject to change. NON-IFRS MEASURES This press release includes certain measures which have not been prepared in accordance with IFRS such as EBITDA, Adjusted EBITDA, Adjusted EBITDA margin and Adjusted EBITDA per share. These non-IFRS measures are not recognized under IFRS and, accordingly, shareholders are cautioned that these measures should not be construed as alternatives to net income determined in accordance with IFRS. The non-IFRS measures presented are unlikely to be comparable to similar measures presented by other issuers. The Company defines EBITDA as earnings before depreciation and amortization, interest expense, amortization of lease incentives, and income tax expense (recovery). Adjusted EBITDA is defined as EBITDA before transaction and restructuring costs, changes in the fair value of the contingent consideration liability, impairments, stock based compensation expense, change in fair value of derivative financial instruments and gain on disposal of property and equipment recognized in the statement of income. Adjusted EBITDA margin is defined as Adjusted EBITDA divided by revenue. Adjusted EBITDA per share is defined as Adjusted EBITDA divided by the weighted outstanding shares on both a basic and diluted basis. The Company believes that Adjusted EBITDA is a meaningful financial metric as it measures cash generated from operations which the Company can use to fund working capital requirements, service interest and principal debt repayments and fund future growth initiatives. The Company's agreements with senior lenders are structured with certain financial performance covenants which includes Adjusted EBITDA as a key component of the covenant calculations. EBITDA and Adjusted EBITDA are not recognized measures under IFRS. Ilan Danieli, Founder and CEO Using a combination of advanced lab technologies, and a platform giving access to expert academic pathologists, Precipio (NASDAQ:PRPO) has staked out a unique position in its battle to prevent misdiagnosis of blood related cancers. “Many studies have found that misdiagnoses can range between 2% in solid tumors and almost 30% in blood-related cancers,” Ilan Danieli, founder and CEO, says in an interview with BioTuesdays. “Misdiagnosis is a significant problem in cancer diagnosis and due to their complexity, blood-related cancers appear most prone to misdiagnosis.” For example, he says there are some 100 different types of lymphoma and each one potentially could have a different treatment. Unique Diagnostic Services delivered via specialized academic pathologists to eliminate diagnostic errors “Our goal is to give physicians the correct diagnosis so patients receive the appropriate treatment, which would help save lives, as well as save insurers billions of dollars and pharma companies have access to accurate data.” Precipio has partnered with the Department of Pathology at Yale University as well as with Harvard’s Dana-Farber Cancer Institute. Yale, for example, employs about 75 pathologists, Mr. Danieli says, noting that the company intends to have a network of pathologists across the country that covers every specialty in the blood cancer space. “We span all aspects of the diagnostic process from proprietary triage algorithms that identify the correct disease state to proprietary in-lab technologies,” he contends. “And then we tap into pathologists at our academic partners to render a diagnosis and improve our accuracy.” Mr. Danieli says Precipio has developed a hybrid pathology service and technology platform to reduce investor risk and increase returns. “The stability of our revenue-generating service business balances the cash needs of our technology investments,” he points out. In addition, Precipio’s clinical laboratory in New Haven, Conn. acts as an incubator, enabling development of a portfolio of technologies, rather than a single technology. “We can develop from an idea to commercialization for about $100,000, which is a fraction of what most companies spend.” Under its pathology services business, Precipio performs the technical lab work, which represents about 80% of reimbursement, while its academic pathology partners perform the professional interpretation work, representing about 20% of reimbursement. “We are not aware of other laboratories pursuing a similar business model as Precipio’s, with its focus on services and products to aid in the misdiagnosis of blood cancers,” analyst Ben Haynor of Alliance Global Partners said in a June 2019 initiation report. The strategy, along with an expanding sales force, seems to be working. Pathology case volume rose 39% in the second quarter of 2019, compared with the same quarter a year earlier; recurring ordering customers jumped 92% and the number of ordering customers was up 8% year-over-year. “Emerging data suggests centralized pathology review in blood cancers should be conducted in clinical cases just as it is done in clinical trials and many large-scale and comprehensive biologic studies,” Mr. Haynor says. Precipio is sponsoring a 1,000-patient study designed to independently evaluate the impact of academic pathology expertise on diagnostic accuracy and confirm its business model as a solution to the problem of misdiagnosis. The study should be complete later this year. In 2018, the company released early data from the study, which showed a fourfold superiority of academic level diagnostic accuracy, compared with industry. The early data also showed that 73% of cases, which academic pathologists determined were previously misdiagnosed, had a definite or possible material impact on patient treatment plans. Positive final data would go a long way in reimbursement discussions and lining up potential customers, Mr. Danieli adds. In addition to its pathology services business, Precipio has developed two recently launched reagent products to improve the lab process following its 2017 merger with Transgenomic and its enabling technology for DNA liquid biopsies. Mr. Danieli says the HemeScreen product enables cost-effective and rapid screening of four genes recommended in the guidelines by the National Comprehensive Cancer Network for patients with myeloproliferative neoplasms and myelodysplastic syndromes. “Most labs batch these tests for cost reasons, leading to two-to-four week turnaround times, while with HemeScreen, laboratories can provide the same information in two-to-four days,” he points out. The company also has developed IV-Cell, a proprietary media that enables culturing of all four hematopoietic cell lineages at once, compared with the existing dominant culture media, which requires the selection of only one cell lineage for culturing at a time. Precipio recently announced a manufacturing agreement with Novamed for production of IV-Cell media for an initial term of three years. The accord would enable Precipio to provide cytogenetics labs in the U.S. and worldwide with IV-Cell media to meet their demand. The company also is in discussions with major labs about in-licensing IV-Cell. Mr. Danieli figures the IV-Cell cytogenic media represents a market potential of $100-million a year, with the molecular HemeScreen media at $50-million a year. AGP’s Mr. Haynor expects future launches will follow IV-Cell and HemeScreen, “targeting smaller markets of less than $100-million, where existing products leave something to be desired in terms of accuracy, ease-of-use, or turnaround time.” In its pathology segment, the company is exploring expansion into renal and neurologic cancers because like blood cancers, “there is a high level of complexity in the diagnosis of those types of cancers as well, leading to misdiagnosis,” he points out. The total U.S. cancer diagnostics market is expected to reach $50-billion in 2020, of which the blood-related cancer drug and diagnostics would account for some $6-billion. Renal and neurologic cancers each represent a market potential of $2-billion, he suggests. “Our success is directly translated into saving patient lives, and that’s what motivates us to get out of bed every morning,” Mr. Danieli says. “We intent to make our products and services available to every patient worldwide. Nobody should be misdiagnosed with cancer in the 21st century.” Market Opportunity • • • • •To connect with Beyond Air, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2ZhwGMZ Steve Lisi, Chairman and CEO Beyond Air (NASDAQ:XAIR), formerly AIT Therapeutics, is developing a proprietary nitric oxide (NO) generator and delivery system that uses NO generated from ambient air, rather than bulky cylinders, and delivers precise amounts of NO to the lungs for the treatment of respiratory and other diseases. “Our goal is to eliminate the use of cylinder-based NO systems currently used in hospitals around the world and potentially enter the home market to treat certain respiratory conditions,” Steve Lisi, chairman and CEO, says in an interview with BioTuesdays. Beyond Air hopes to file for premarket approval with the FDA around the end of September 2019 for its cylinder-free NO generator and delivery system, the LungFit, to treat pulmonary hypertension (PH), or a narrowing of the pulmonary arteries in certain ventilated patients. In January 2019, Beyond Air licensed commercial rights to LungFit PH to Circassia Pharmaceuticals (LSE:CIR) of London, a specialty pharmaceutical company focused on respiratory diseases, for the U.S. and China markets. Circassia plans a U.S. commercial launch in the second quarter of 2020. Under the accord, Beyond Air is in line to receive $32.55-million in potential milestone payments, and royalties of 15% on net sales up to $100-million and 20% on net sales in excess of $100-million. Beyond Air retains commercial rights to LungFit PH in Europe and expects to receive CE Mark for its device in the first half of 2020. Mr. Lisi explains that LungFit PH is a portable system that utilizes electric voltage to produce precise quantities of NO from the nitrogen and oxygen in ambient air. And it uses a disposable filter to remove unwanted NO₂ produced during the chemical process. “The system will not operate without our filter, thus this is our razor-razor blade business model as each filter has a 12-hour life, so you need two filters each day,” he adds. Inhaled NO is a pulmonary vasodilator, which is approved in the U.S. for use as part of a regimen in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension in infants. Outside of the U.S., inhaled NO also is used as part of the treatment of pulmonary hypertension associated with cardiac surgery. Beyond Air has conducted more than 2,100 treatments with its LungFit platform in more than 85 patients in eight studies at NO concentrations of more than 150 parts per million (ppm), many times in excess of normal treatment level of 20 ppm for pulmonary hypertension in infants. Mr. Lisi says there have been no serious adverse events related to NO therapy. Pulmonary hypertension is a life-threatening condition resulting from increased pulmonary vascular resistance and leading to decreased pulmonary blood flow. Beyond Air estimates the pulmonary hypertension market in U.S. hospitals has a sales potential of more than $300-million a year at peak sales, with the global market exceeding $600-million. According to Mr. Lisi, inhaled NO causes smooth muscle relaxation, which increases blood flow to the lungs and decreases the workload on the right ventricle. Currently, hospitals use two, 45-pound NO cylinders on a cart, plus a delivery system, weighing a total of about 175 pounds. “Our commercial generator, with a back-up system included, mounted on a cart would weigh 50 pounds. Plus, our system provides the hospital with the flexibility for use without a cart where the system would weigh just 20 pounds,” Mr. Lisi contends. He suggests that hospitals would have a significant cost and logistics advantage with LungFit PH, avoiding burdensome cylinder inventory and storage requirements. In addition, NO is supplied by LungFit PH as a hypoxic gas mixture and there are no purging procedures or additional safety measures needed to clear NO₂, a toxic gas, which is removed by the filter in the device. “From a company standpoint, we don’t have any expenses associated with a manufacturing facility and we don’t have any logistics expenses delivering NO cylinders,” Mr. Lisi adds. There are some 800 hospitals in the U.S. now using NO cylinders. However, there are more than 1,000 neonatal intensive care units in the U.S., according to the American Academy of Pediatrics and American Hospital Association. “We expect to expand the current market by providing lower costs and ease of use, compared with cylinder systems,” Mr. Lisi contends. Beyond Air has more than 20 issued patents and more than 10 patents pending across major global markets, which could run through 2037. The company’s IP covers its generator; breathing circuit; NO concentration, action in the body and dosing; the NO₂ filter and methods of use. Beyond Air’s second indication is bronchiolitis, or acute lower respiratory infection, in early infancy. The company has completed two pilot studies in Israel with its LungFit BRO device, demonstrating a 24-hour reduction in the length of hospitalization, along with no serious adverse events. “We treated babies in the pediatric unit, not in the NICU where NO cylinder systems are confined to,” Mr. Lisi says. “Discharging babies sooner has its obvious costs benefits for hospitals and insurers.” Bronchiolitis is the most common reason for pediatric hospitalization in the U.S. and a leading cause of global child mortality. There are no drugs approved for bronchiolitis and the standard of care is oxygen and hydration. Beyond Air estimates the global market for bronchiolitis, where there is no competitor in the market, at more than $1.2-billion a year. Mr. Lisi says the company wants to conduct a pivotal trial in the U.S. with LungFit BRO during the winter of 2020-2021. “Our goal would be to reduce the duration of bronchiolitis symptoms in infants and the length of hospitalization. The longer infants remain in hospital, the greater the risk for both hospital acquired infection and respiratory problems as they age.” Studies have shown that infants with acute bronchiolitis can remain in hospital for three-to-four days. Mr. Lisi says that eliminating high-pressure cylinders could make NO therapy accessible at home, where patients can self-administer. The LungFit plugs into any standard electrical outlet and requires a Beyond Air filter. After the mask is positioned on the face, patients only needs to press, go, he adds. Beyond Air’s third indication is for severe lung infections, such as nontuberculous mycobacteria (NTM), with an initial target of NTM abscessus (MABSC), the most aggressive and difficult to treat form of NTM. The company plans to seek approval in NTM MAC (mycobacterium avium complex) following MABSC approval or potentially concurrently, pending further developments. “NTM is an FDA disease of focus with limited [treatment] options. Patients can die within a few years from diagnosis,” Mr. Lisi points out. In an earlier pilot study in Israel, with nine cystic fibrosis patients with refractory MABSC, the company’s NO formulation yielded positive safety and clinical results in measuring patients’ six-minute walk and FEV1, or the amount of air exhaled in one second. Beyond Air hopes to begin a 12-week pilot study in the second quarter of 2020, where patients with NTM lung infections, excluding asthma, would self-administer NO therapy with the company’s LungFit NTM device at home at concentrations of up to 250 ppm. The company expects to release the study data around the end of 2020. A pivotal study is slated to begin in the second half of 2021 and finish in the first half of 2023, leading to possible FDA approval and launch in 2024, Mr. Lisi suggests. “Extensive in vitro data already exist supporting the direct killing effect of NO on MABSC,” he says, adding that NO therapy can target other severe, chronic and refractory infections, such as Pseudomonas aeruginosa, the most common pulmonary pathogen in patients with cystic fibrosis. “Continuous exposure to NO at 200 ppm has been shown to kill 100% of P. aeruginosa bacteria in four-to-five hours.” • • • • •To connect with Beyond Air, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2TKq9UU Roger Aston, Executive Chairman PharmAust (ASX:PAA) is gearing up to begin a pivotal Phase 2 study in Australia with its lead veterinary drug candidate, monepantel, for the treatment of lymphoma in canines, which if successful, could open the door to human use in a much larger market. “We should have some results of the Phase 2 study in November or December this year and we’ll see where we go from there in terms of a human development program,” Roger Aston, executive chairman, says in an interview with BioTuesdays. “If the canine study is successful, I don’t foresee any problem enticing a Big Pharma oncology company to license and develop monepantel for human use,” he adds. “A number of centers already have expressed an interest in looking at our compound as a treatment for cancer in humans based on the work we’ve done.” Dr. Aston explains that monepantel is a repurposed drug already approved as an anti-parasitic in sheep by Elanco US Inc. PharmAust has patented monepantel as an anti-cancer drug and has an option agreement with Elanco for veterinary cancer applications. Elanco (NYSE:ELAN), a leading global animal health company, recently outlined a new strategy to become a major player in the animal oncology space, which Dr. Aston says provides PharmAust with unique advantages moving monepantel forward. For example, PharmAust has reformulated pills with monepantel supplied by Elanco for its upcoming Phase 2 study. According to Dr. Aston, many chemotherapy agents given to dogs are reformulated versions of the same agents that are given to humans. “The veterinary therapeutic market is dominated by repurposed drugs already approved for use in humans and/or animals.” In addition, he points out that cancer studies in dogs are highly reflective of what a drug will do in humans. The reverse is also generally true. Repurposing of approved drugs potentially offers companies accelerated development and registration timelines. Six million dogs are diagnosed with cancer in the U.S. each year and one-in-four will die of cancer. However, pets are living longer as owners are willing to pay $2,000-to-$5,000 for certain major treatments, contributing to a pet drug market of more than $10-billion in the U.S. in 2018. Dr. Aston suggests that the annual U.S. cancer chemotherapy market alone in dogs is valued at $500-million to $600-million, if a safe drug exists with minimal side effects. “But that figure only covers about 20% of dogs undergoing treatment. We believe our market potential for monepantel is much higher because owners more often than not do not wish to put their pets through a chemotherapy treatment regimen. We are targeting 100% of dogs needing treatment as monepantel has minimal side effects in canines,” he adds. New oncology drugs for dogs represent an unmet need because of the significant side effects associated with chemotherapy. “Monepantel comparatively has little or no side effects,” Dr. Aston contends. In 2017, PharmAust conducted a small pilot study in dogs with lymphoma that showed monepantel was effective at progression free survival (PFS). Of the seven dogs in the study, six showed statistical significance in PFS with an earlier formulation of the drug. “We believe monepantel’s mode of action inhibits the mTOR pathway, which is connected to cell replication and quiescence in certain types of cancer,” he suggests. Dr. Aston says the company performed an extensive reformulation program in 2018 and 2019 to develop a new, high-dose version of monepantel tablets, manufactured under GMP, which resulted in an improved pharmacokinetic profile. The program also improved the taste of monepantel, which was previously unpalatable, suggesting that dosing canines by their owners would be much less challenging. PharmAust received approval from the NSW Department for Animal Care and Ethics Committee as well as the State of Victoria to begin its Phase 2 study with the newly formulated tablets. Dr. Aston says the study should begin in August or September after PharmAust receives monepantel tablets from a manufacturer in the U.S. “We’ve given Elanco an option to license the veterinary oncology application for monepantel and we expect to present Elanco with an interim dossier in November or December.” The 28-day Phase 2 open-label study is expected to first enroll up to 16 dogs. Anti-cancer efficacy is measured by achieving stable disease and PFS or regression of tumors. Preventing metastasis of the cancer also will be monitored. “We can cut the trial short if we see a profound effect and the longer we can suppress the tumor, the more commercial monepantel is,” he adds. “Ultimately, we hope pet owners would put their companion animals on a maintenance treatment of monepantel and avoid the side effects of chemotherapy,” Dr. Aston says. “By putting the tumor into stasis, dogs would be able to build immunity to the tumor until their immune system is capable of removing it. The ultimate goal here is to improve quality of life.” • • • • •To connect with PharmAust, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2H5Niw1 Shawn Shirazi, CEO Theralase Technologies (TSXV:TLT; OTCQB:TLTFF) has designed its Phase 2 clinical study in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) based on FDA industry guidance issued in February 2018. “The FDA confirmed that our protocol is aligned with the said guidance during our pre-IND conference call with the agency in June 2019 and if the trial is successful, it could support an application for marketing approval,” Shawn Shirazi, CEO of Theralase’s drug division, says in an interview with BioTuesdays. “The FDA guidelines state that in Bacillus Calmette-Guérin(BCG)-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application,” he adds. “We also have the potential for fast track designation as we demonstrated a strong safety profile and obtained a strong efficacy signal in an earlier Phase 1b NMIBC study.” Two-of-three patients that received one therapeutic dose in the Phase 1b study had no clinical evidence of bladder cancer after 360 days. Theralase began its Phase 2 study in April 2019. The company plans to enroll approximately 100 BCG-unresponsive NMIBC patients in a single-arm, open-label study at approximately 20 clinical study sites, beginning initially in Canada, before expanding to the U.S. in the fourth quarter of 2019. Theralase’s Anti-Cancer Technology division focuses on light-activated photodynamic compounds, such as its lead drug, TLD-1433, and development of laser systems that activate TLD-1433 to target and destroy cancer cells. Dr. Shirazi explains thatTLD-1433 is instilled into the bladder through a catheter, where it is absorbed preferentially by the bladder cancer cells. TLD-1433 MECHANISM OF ACTION(18) “Once TLD-1433 is absorbed by the cancer cells, it is light activated to produce powerful cytotoxins in the form of reactive oxygen species and singlet oxygen to destroy the cancer cell from within,” he adds. In addition, he notes that pharmacokinetic studies have shown that TLD-1433 is removed from the body via urine (at nanograms per milliliter) within 24 hours and via plasma (at pictograms per milliliter) within 72 hours, so there is no photosensitivity issues presented to a patient. The procedure could eventually be performed as outpatient day surgery; however, this is not planned during the Phase 2 clinical study, Dr. Shirazi says. The company’s IP includes 12 issued and 34 patents pending. Its U.S. composition of matter patent expires in June 2034. “Therefore, we have plenty of time to enjoy the fruits of its labor, if we are successful in commercializing this novel technology.” There are some 240,000 new cases of bladder cancer in the U.S., Canada and certain European countries each year, of which 70% are classified as NMIBC. And 30% of these cases unfortunately become unresponsive to BCG standard of care within one year. The standard of care for patients with high-grade NMIBC is intravesical BCG following trans urethral resection of the bladder tumor. However, there is an up to 80% rate of tumor recurrence and up to 50% disease progression within five years. When patients fail to respond to current standard of care, clinical treatment guidelines call for a radical cystectomy, or surgical removal of the bladder and adjacent organs, which can significantly affect a patient’s quality of life, Dr. Shirazi points out. “We are seeking regulatory approval for a drug/device combination as an alternative for patients who are unfit for cystectomy surgery or desire bladder-preserving therapies.” During a pre-IND conference call in June this year, the FDA confirmed that the company’s Phase 2 protocol is in accordance with the agency’s guidelines. “This has the potential to make our Phase 2 study a pivotal study,” he suggests. Theralase expects to enlist four clinical sites in Canada and up to 16 in the U.S. for the Phase 2 clinical study. Patients will be evaluated at a therapeutic dose of 0.70 mg/cm2. Unlike the Phase 1b study, where patients received one therapeutic procedure, patients in the Phase 2 study will receive two treatments at day zero and day 180. The primary endpoint is complete response at any time post-initial treatment and duration of complete response at 360 days. Dr. Shirazi says complete response requires at least one of the following:
The secondary outcome will measure safety by the incidence and severity of adverse events grade 4 or higher that do not resolve within 360 days post-initial treatment. “This is well above anything we saw in the Phase 1b, as no adverse events were noted beyond grade 1 or 2 (mild or moderate) and of these, 95% were resolved completely within 180 days, with the remaining 5% deemed not study related by the principal investigator, as they were pre-existing indications,” he adds Theralase is hoping to bring all of its clinical sites on board before the end of 2019 or early 2020. The company also hopes to enroll and treat all 100 patients during 2020 and follow them for 360 days in 2021. That could put the company in a position to file for marketing approval in the first half of 2022, if the study is successful. “The Phase 2 is an open label study and if we see similar results to our Phase 1b study for efficacy on an interim basis, say, after the first 20 or 25 patients, we may have the opportunity to meet with the FDA and review the results, with a focus on obtaining accelerated approval,” Dr. Shirazi points out. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2GSFpdo Dr. Robert Foster, CEO Hepion Pharmaceuticals (NASDAQ:HEPA), which recently changed its name from ContraVir Pharmaceuticals, is developing targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The company is currently testing its lead drug candidate, CRV431, in Phase 1 trials for HBV, and recently received the FDA’s authorization to commence an IND opening study for the treatment of NASH, which complements Hepion’s current IND for the HBV indication. In this interview with BioTuesdays, Dr. Robert Foster discusses NASH, data the company has generated to-date, and its clinical development plans for CRV431. What is NASH? NASH is the more severe form of non-alcoholic fatty liver disease, or NAFLD. NAFLD and NASH are major contributors to the development of significant liver disease. Other contributors include alcohol consumption and viral hepatitis. Any of these factors can trigger a series of events that can lead to end-stage liver disease and liver failure, which may be life threatening. NASH patients typically have fatty livers with inflammation and ballooning – or liver cell degeneration, and fibrosis – or scarring, which results from the deposition of collagens and other molecules into a stiff matrix outside of cells. The amount of fibrosis is the major determinant of disease progression to cirrhosis and hepatocellular carcinoma, the most common form of liver cancer, of which NASH is a leading cause. Why has this indication been gaining attention? NASH has been gaining attention because of the rising prevalence of fatty liver disease. Approximately 1-in-4 individuals globally have fatty liver disease, and an estimated 3-5% of the world’s population has NASH. So, I think more companies are interested in this indication because a treatment could generate life-saving therapies and also create real value for all stakeholders. The fact that there are currently no approved treatments for NASH is driving further interest in this indication, and it is expected that NASH will become the primary reason for liver transplants. Have improved diagnostics contributed to the interest? To some degree, yes, as our ability to diagnose NASH has improved, but it’s not nearly as much of a driver as the global epidemic of NAFLD. Historically, the only way to confirm the presence of NASH was by liver biopsy, and that method is less than perfect. So, the availability of more tools enables less invasive and more accurate diagnoses. These include more sophisticated imaging, series of blood tests and lab panels, and transcriptome and metabolome profiling. These tools are especially important as a large portion of individuals who have NAFLD aren’t aware of it. A common misconception is that NAFLD only occurs in significantly overweight or obese individuals, but there is what is referred to as “lean NASH,” where the disease presents in seemingly healthy individuals. What is CRV431? CRV431 is an orally administered cyclophilin inhibitor that we believe will be administered once daily. Cyclophilins are enzymes that catalyze protein folding processes that are important for the three-dimensional configuration of proteins, and in turn, their function. Specifically, cyclophilins regulate folding at one unique protein building block, the amino acid, proline. Many disease processes are characterized by an overproduction of proteins, and therefore disrupting the production of properly folded proteins with CRV431 is one strategy for treating disease. CRV431 is based on the scaffold of cyclosporine, an immunosuppressive drug that also binds cyclophilins. The major difference between these molecules is that the binding of cyclosporine to calcineurin has been chemically removed in CRV431, so it does not have the immunosuppressive properties of cyclosporine. The cyclosporine scaffold of CRV431 however, has been chemically modified to enhance binding to cyclophilins. These novel chemical modifications are what confer the properties of CRV431, and since cyclosporine has been used commercially in North America since 1983, for a variety of indications, we don’t anticipate any safety issues with CRV431. How does CRV431 work to reduce fibrosis? Collagen is the most abundant protein in fibrotic scars, and proline is extremely abundant in collagen. By targeting proline, cyclophilins play a major role in both the amount of collagen produced and the formation of its intricate helical and crosslinked conformations. Therefore, the evidence is quite compelling that CRV431 can reduce fibrosis by blocking the roles of cyclophilins in collagen production and folding. Additionally, experiments from our laboratory indicate that CRV431 can also change the expression of many genes that contribute to fibrosis. These genes include not only collagen and other building block molecules, but also other enzymes (e.g. lysyl oxidases) that help to construct the fibrotic matrix. Experiments are ongoing to try to understand this second important mode of action of CRV431. How does CRV431 work as an antiviral? Many viruses, including HBV and HCV, have “learned” to take advantage of cyclophilins to help them to replicate and evade the immune system. Certain viral proteins bind to cyclophilins to help them fold and function in ways that benefit the viruses. One example is the HBV surface antigen protein, HBsAg, which is produced in extreme quantities by HBV and seems to protect the virus from the immune system. CRV431 blocks the binding of cyclophilin A to HBsAg, which leads to lower HBsAg production in experimental models. It would be exciting to see a similar effect in human HBV patients, as current antiviral treatments largely do not affect HBsAg concentrations in the blood. Interestingly, CRV431 can also exert anti-HBV activity independent of cyclophilin inhibition by binding directly to a protein called NTCP on the surface of liver cells that acts as an HBV receptor. Therefore, CRV431 has the potential to reduce new infection and re-infection of liver cells by HBV. Hepion was originally targeting HBV with CRV431. What led to the expansion to the NASH indication? The ultimate goal of antiviral drug development is to completely eradicate viruses from patients and restore antiviral immunity. However, achieving such a “sterilizing cure” for HBV infection is very complex due to the nature of this very stealthy virus. Commercialized drugs that reduce HBV viremia already exist, but they rarely lead to complete elimination of the virus. CRV431 has shown anti-HBV effects in many experimental models, so it has potential to improve upon existing treatments. Achieving a sterilizing cure still remains a very lofty goal, and one that will be very challenging. Based on our own experiments on CRV431 and on the scientific knowledge of cyclophilins’ role in HBV infection and fibrosis, we concluded that the likelihood that CRV431 could impact fibrosis, inflammation, and other related disease processes was greater than its complete eradication of HBV. The high prevalence of fibrosis as a disease process means that CRV431 might also hold potential in lung, heart, kidney, or other organ disorders where fibrosis plays a role. The increasing prevalence of NASH was also a contributing factor in our decision to focus on CRV431 as an antifibrotic. Approximately 250 million people worldwide are chronically infected with HBV, and the risk of developing liver fibrosis and cancer in these individuals remains a significant problem. When fatty liver disease and NASH are overlaid upon the HBV population, the diversity of mechanisms through which CRV431 could benefit patients becomes even greater. Our data generated thus far point to CRV431’s antifibrotic effects as translating to the greatest possible therapeutic and commercial success. What data has Hepion generated for CRV431 in NASH? We originally used a STAM NASH mouse model to test CRV431’s ability to decrease NAFLD scores, which consider the extent of inflammation, steatosis and ballooning. We found that treatment with CRV431 earlier in the disease course decreased NAFLD scores. This seems to indicate to us that CRV431, given early, may alter the steatohepatitis, ballooning, and inflammation of the liver. However, the results we saw with fibrosis were even more exciting. To explore CRV431’s impact on fibrosis, we conducted four separate and independent studies in the same NASH model. We quantified the amount of collagen after treatment with CRV431 and consistently saw a statistically significant decrease in the amount of fibrotic scarring. And, the antifibrotic activity we observed appeared to be quite potent, even when we compared CRV431 to other late clinical stage compounds. Tell us about the data you collected from two new NASH models. After we determined that CRV431 consistently performed very well in the NASH animal model, we decided to conduct another study that focused more closely on fibrosis. In this study, we used a completely different inducer of liver fibrosis, carbon tetrachloride, and found CRV431 produced a statistically significant decrease in fibrosis. For comparison, we tested obeticholic acid (OCA), another NASH drug candidate, which did not appear to have any anti-fibrotic effect in this particular model. Most recently, we tested CRV431 on precision-cut human liver slices, a model that is likely the most applicable to human disease. Here, fibrosis was induced with physiological molecules, TGFβ and PDGFββ, which are known to participate extensively in human fibrotic diseases. We observed that CRV431 also decreased fibrosis in this experimental model, and did so to a greater degree than OCA, as well as another comparator, elafibranor, an NAFLD drug candidate. What are Hepion’s upcoming development plans for CRV431? Our near-term plans are to initiate an IND-opening study that will obtain CRV431 pharmacokinetic data from patients with varying degrees of hepatic impairment. We are also planning to launch a 28-day multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of CRV431. This study will be conducted in virally-suppressed HBV patients in which we will also explore markers of HBV infection and liver fibrosis for early signs of efficacy. How do you envision CRV431 being used in NAFLD and NASH patients? Currently, NAFLD and NASH treatment is commonly focused on addressing the diseases’ main contributors, such as metabolic disorders and inflammation. We believe that CRV431 may be truly antifibrotic. We will continue to study CRV431 and anticipate that our drug candidate may become an important player in the treatment of NASH, fibrosis, and more broadly speaking, the treatment of liver disease. • • • • •To connect with Hepion, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2OpivAr Kenneth L. Waggoner, CEO, President and General Counsel PharmaCyte Biotech (OTCQB:PMCB) is developing cellular therapies for its lead pancreatic cancer program and for diabetes that are based on a proprietary cellulose-based live cell encapsulation technology known as a Cell-in-a-Box. “When used for pancreatic cancer treatment, the combination of Cell-in-a-Box encapsulation plus a cancer prodrug, which needs to be converted to its cancer-killing form by the cells in the Cell-in-a-Box capsules, turns out to be a completely unique approach to the treatment of pancreatic cancer,” CEO, president and general counsel, Kenneth L. Waggoner, says in an interview with BioTuesdays. “In very early clinical trials, this combination produced a strong antitumor effect at the tumor site, with little-to-no treatment-related side effects,” he adds. Mr. Waggoner explains that to treat pancreatic cancer, PharmaCyte’s platform technology encapsulates genetically modified live cells that are used with a cancer prodrug, ifosfamide. These modified encapsulated cells are implanted in the blood supply as close as possible to the tumor site. After implantation, ifosfamide is given intravenously at one-third the normal dose, he points out. When the IV ifosfamide reaches the encapsulated cells, it is designed to flow through pores in the capsules, where the genetically modified live cells produce an enzyme that converts ifosfamide into its cancer-killing form, he adds. Mechanism of Action Mr. Waggoner contends that the live cells inside the capsule act as a “bio-artificial liver” activating the chemotherapy at the site of the cancer. “We use the term bio-artificial liver because if the Cell-in-a-Box capsules were not present near the tumor, the inactive prodrug would not be converted into its active form until it passed through the liver,” he says. “Thereafter, the activated ifosfamide, which has a short biological half-life, would be very diluted by the time it reached the pancreatic tumor and the anticancer effectiveness of the ifosfamide would be quite low.” Mr. Waggoner contends that the implanted capsules do not impede the blood supply to the pancreas and thus to the tumor. This “targeted chemotherapy has proven effective and safe to use in earlier clinical trials, with little to no treatment-related side effects.” A single implantation consists of 300 Cell-in-a-Box capsules, which are each the size of a head of a pin, Mr. Waggoner says, with each capsule containing approximately 20,000 genetically modified live cells. Mr. Waggoner points out that a normal dose of ifosfamide has shown success in treating some cancers, including pancreatic cancer, but clinicians are reluctant to use a normal dose because of its severe toxicity. “If this technology can be solidly proven in the clinic, it will change how certain types of solid tumors are treated for a very long time,” he contends. COO of PharmaCyte, Gerald W. Crabtree Gerald W. Crabtree, COO of PharmaCyte, says the Cell-in-a-Box capsules, which are made of bio-inert cellulose (cotton), have been shown to be safe, effective and durable for at least two years in the body. In addition, the pores in the capsules are too small for immune system cells to enter or encapsulated live cells to leave.” Dr. Crabtree explains that other live cell encapsulation technologies have used alginate, which is derived from seaweed, and alginate derivatives, but many of these tend to produce more of a gel than a capsule. “In addition, alginate-based capsules tend to be far less robust and less stable than our Cell-in-a-Box capsules, and they can’t be frozen for long-term storage or the long-distance shipment.” Pancreatic cancer is the third leading cause of cancer-related deaths in the western world, with an overall survival rate of 8%. Some 72% of patients will die within the first year of diagnosis and more than 90% will die within two years after diagnosis. Patients have less than six-months average life expectancy after diagnosis without treatment. In addition, pancreatic cancer is usually not diagnosed until it is advanced and inoperable. However, advances in imaging technologies have enabled the disease to be diagnosed earlier. Still, there is no cure unless the tumor is surgically removed in its earliest stages. Since the first chemotherapy drug, gemcitabine, was approved by the FDA for pancreatic cancer in 1996, some 40 unsuccessful pivotal trials have been conducted to find a combination therapy to improve on gemcitabine alone, Dr. Crabtree recalls The current standard of care is a combination of gemcitabine and Abraxane. The FDA approved the combination chemotherapy in 2013. While there are severe side effects associated with gemcitabine plus Abraxane therapy, the combination has increased the percentage of one-year survivors to 38% from 22% with gemcitabine alone. FOLFIRINOX, a combination of four chemotherapy agents – folinic acid, 5-fluorouracil, irinotecan and oxaliplatin – has been used outside of North America for patients with metastatic and locally advanced pancreatic cancer, and is now used in America in some cases, before surgery to shrink the tumor as much as possible. However, FOLFIRINOX does not have marketing approval and comes with severe side effects. In the 1990s, a Danish company, Bavarian Nordic, sponsored two small clinical trials in Europe in patients with stage 3 and 4 pancreatic cancer. Although historical data were used as a control in these trials, it was possible to compare the data from patients that had received gemcitabine alone, Dr. Crabtree recalls. In these trials, an earlier version of the Cell-in-a-Box plus low doses of ifosfamide was used. The Cell-in-a-Box-based therapy was found to be safe, effective and well tolerated by patients. Mr. Waggoner says that in some cases, a patient’s tumor went from inoperable to operable. PharmaCyte, which licensed the Cell-in-a-Box technology in 2013, is currently finalizing an IND that, if approved by the FDA, would allow PharmaCyte to conduct a Phase 2b trial in the U.S. The trial would be scheduled to start in the first quarter of 2020. Mr. Waggoner says the company is targeting a critical unmet medical need that exists for patients with advanced pancreatic cancer whose tumors are locally advanced, non-metastatic and inoperable, and no longer respond to Abraxane plus gemcitabine or FOLFIRINOX therapy. “The goal of the trial is to show that PharmaCyte’s therapy for pancreatic cancer can serve as a consolidation therapy with Abraxane plus gemcitabine or FOLFIRINOX, where no satisfactory consolidation therapy currently exists,” he adds. The company plans to randomize 100 patients into three groups. Fifty patients will receive PharmaCyte’s pancreatic cancer therapy, while the other 50 will receive capecitabine, a chemotherapy, plus external beam radiation, or stereotactic body radiation alone. Mr. Waggoner says each patient in the PharmaCyte therapy group will receive a single implantation of 300 Cell-in-a-Box capsules, which will be implanted in the patients’ bodies three days before they begin receiving multiple courses of low-dose ifosfamide. The administration of the ifosfamide will continue until patients become refractory to the drug or their disease progresses. The primary endpoint of the trial is progression-free survival. Among secondary endpoints are overall survival; objective response rate, complete and partial responses; and determining the number of patients whose tumors are converted from an inoperable state to an operable one post-treatment, he adds. Three internationally renowned pancreatic cancer oncologists – Dr. Daniel Von Hoff, Dr. Manuel Hidalgo and Dr. Matthias Löhr - played leading roles in identifying and designing the Phase 2b trial. Dr. Von Hoff has been a leading figure in the development of cancer drugs for many years; and Dr. Löhr was the principal investigator (PI) of the earlier Phase 1/2 trials and is currently chairman of PharmaCyte’s medical and scientific advisory board. Dr. Hidalgo is the PI for the company’s upcoming Phase 2b study. PharmaCyte has partnered with Austrianova Singapore Pte. to manufacture the Cell-in-a-Box clinical trial material at its cGMP manufacturing facility in Bangkok, Thailand. “Production is being validated on an ongoing basis, and we expect release of clinical trial material in the U.S. during the fourth quarter of 2019,” Mr. Waggoner offers. PharmaCyte has orphan drug designation for its pancreatic cancer therapy in the U.S. and Europe. It also has eligibility under the Biologics Price Competition and Innovation Act, which provides 12 years of market exclusivity in the U.S. and Europe. PharmaCyte’s patent portfolio includes the encapsulation process, which uses unique patent-protected cellulose sulphate and is a pivotal ingredient in the formation of the Cell-in-a-Box capsules; patents protecting genetically engineered cells that convert a cancer prodrug into its active form; as well as Melligen insulin-producing cells that may be a pivotal part of the company’s diabetes program. The company’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes, though still in the preclinical stage, involves encapsulating genetically modified liver cells that are called Melligen cells. PharmaCyte also will be examining the use of stem cells and beta islet cells that have been encapsulated using the Cell-in-a-Box technology and then implanting these capsules in the body. Mr. Waggoner explains that Melligen cells are human liver cells that have been modified to produce, store and release insulin in response to concentrations of glucose in the body. In addition, Melligen cells have demonstrated the ability to reverse the diabetic condition in immunosuppressed diabetic mice. PharmaCyte has an exclusive worldwide license to use Melligen insulin-producing cells to treat diabetes. “In a way that is analogous to how Cell-in-a-Box capsules protect the cells from immune system attack in the body when they are used as part of a pancreatic cancer treatment, they should do the same thing for insulin-producing cells,” Mr. Waggoner says. “These types of cells are designed to function as a bio-artificial pancreas for purposes of insulin production.” Pipeline • • • • •To connect with PharmaCyte, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2YkcAR2 AceAge receives initial purchase order for 6,000 Karie devices for European market Toronto, Ontario, July 23, 2019 AceAge Inc. (“AceAge”) and Centric Health Corporation (“Centric Health”) (TSX: CHH) are pleased to announce that AceAge has signed a distribution agreement with a European partner that is a leader in the home health and seniors healthcare services market. The distribution agreement includes an initial purchase order for 6,000 Karie devices, with deliveries commencing in the fourth quarter of 2019. “This is an exciting milestone as this agreement, and sizable order of Karie devices, are AceAge’s first steps outside our Canadian borders,” said Spencer Waugh, Chief Executive Officer of AceAge. “We are ecstatic to be aligned with a world leader of integrated telemedicine.” Following an initial launch of Karie in the Canadian market earlier this year, AceAge continues to gain traction across multiple jurisdictions and is scaling up operations appropriately to meet this demand. “AceAge’s European distribution agreement is a meaningful validation of the Karie technology and the global demand for this innovative product,” said David Murphy, President and Chief Executive Officer of Centric Health. “As both a significant shareholder of AceAge and their preferred Canadian pharmacy, we continue to be excited about this partnership and look forward to supporting the continued deployment of Karie in Canada and around the world.” About AceAge Inc.
AceAge is a healthcare technology company, creating intuitive products to ease the aging process and improve health outcomes. AceAge’s Karie device is a home-based automated drug delivery appliance that makes it simple to follow complex medication regimes by automatically delivering prescription drugs, in the correct dosage and at the right time. The medication comes pre-organized in an easy-to-load cartridge and the patient's medication schedule is also stored. Karie provides audio and visual cues when it's time for each dose and provides a visual and audio alert. It can also be set to automatically notify a family member or caregiver if a dose is ever missed. It is a simple, easy to use solution that provides peace of mind to the children of seniors and other family members given that adverse drug reactions is one of the leading causes of emergency room visits and hospital admissions in the seniors population. Karie also incorporates facial recognition which ensures the safety of the user and protects others, network connectivity using TELUS' cellular IoT network and is Bluetooth-enabled to connect to other health monitoring devices. To view a demonstration video of Karie, please click here: http://bit.ly/KarieDevice. About Centric Health Centric Health’s vision is to be the leading provider of pharmacy and other healthcare services to Canadian seniors. The Company is one of Canada's leading, and most trusted providers of comprehensive Specialty Pharmacy services and solutions to seniors. We operate a large national network of pharmacy fulfilment centres that deliver high-volume solutions for the cost-effective supply of chronic medication and other specialty clinical pharmacy services, serving more than 31,000 residents in over 450 seniors communities (long-term care, retirement homes, and assisted living facilities) nationally. With services that address the growing demand within the Canadian healthcare system, Centric Health's unparalleled national care delivery platform provides significant potential for future expansion and growth. Centric Health currently has a 19.5% ownership interest in AceAge with the ability to increase its investment to up to 32.5%. Source: AceAge Inc. and Centric Health Corporation |
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