Dr. Agron Lumiani, leading German radiologist
After nearly a decade of R&D, Profound Medical (OTCQX:PRFMF; TSXV:PRN) is now conducting a pilot launch of its TULSA-PRO medical device to ablate tissue in localized prostate cancer within key European and other CE Mark jurisdictions ahead of full commercialization.
The first focal therapy with TULSA-PRO was successfully conducted at the ALTA Klinik in Bielefeld, Germany last week under the supervision of Dr. Agron Lumiani, a leading German radiologist and an early adopter of the use of MRI for prostate diseases imaging and biopsy.
Arun Menawat, CEO of Profound Medical, describes the pilot program as a great step forward in the journey to commercialize the TULSA-PRO system within Europe, and in building awareness about the technology as an attractive clinical option for patients with localized prostate cancer.
“We also believe it will act as a strong catalyst for further adoption of the therapy as we continue our penetration into other European and international markets,” Dr. Menawat adds. “We look forward to continue working with Dr. Lumiani, to address the unmet needs of patients who suffer from this disease.”
The TULSA-PRO system is an innovative, minimally invasive way to ablate tissue in patients with localized prostate cancer.
Arun Menawat, profound medical's CEO
The system uses MRI to carefully map out the unique shape of a patient’s prostate and plan the treatment best suited for their needs. The TULSA-PRO procedure then uses MRI guided, robotically-driven, therapeutic ultrasound, with real-time thermal feedback to accurately and precisely ablate the prostate tissue, all while preserving surrounding healthy tissue.
The same-day TULSA procedure is precise, accurate and offers low rates of serious or long-term adverse effects.
Profound is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which is designed to further demonstrate the safety and effectiveness of its technology. If successful, TACT is expected to support Profound's application to the FDA for approval to market TULSA-PRO in the U.S.
To support the rollout, the company has established strategic partnership/collaborations with two global medical device developers - Royal Philips and Siemens Healthcare.
In addition to ensuring compatibility of TULSA-PRO with their MRI platforms, Philips and Siemens are collaborating on the capital unit placements as well as joint marketing activities. Profound has publicly announced the sale of four commercial units.
Dr. Lumiani has been working with MRI technology since 1984 and founded the ALTA Klinik 11 years ago to focus on MRI diagnostics for prostate diseases. Since then, his clinic has performed more than 6,000 MRI examinations of the prostate.
“Our patients come from all over Germany and neighboring countries,” Dr. Lumiani says in an interview with BioTuesdays. “MRI examination of the prostate has become increasingly important for urologists.
MRI diagnostics, as a primary diagnostics, form the basis for detecting prostate cancer, even at an early stage. “MRI-guided and targeted prostate biopsy enables superior diagnostic clarity for prostate cancer, as it can ensure that the biopsy material comes directly from the suspected lesions,” he points out.
The TULSA-PRO system is an innovative, minimally invasive way to ablate tissue in patients with localized prostate cancer
“Although our biopsy method is MRI-guided and targeted, we also take out systematic tissue samples to give the patient maximum certainty in the result,” he adds. “The result of the biopsy helps the urologist to define the individualized treatment for each patient.”
Dr. Lumiani recalls that in 2009, his clinic developed a MRI-guided, targeted transgluteal transforaminal prostate biopsy. “It was important for me to find a way to access the prostate that did not involve going through the rectum, since that route leads to intestinal bacteria reaching the prostate, which requires a patient to take prophylactic antibiotics.”
The transgluteal transforaminal path to the prostate is ideal because access is sterile and painless, and enables reaching all suspicious lesions in the prostate, he adds. Ultimately, the rectum is left untouched, and other organs are not injured as a result.
Dr. Lumiani also has had positive results with transrectal HIFU (high-intensity focused ultrasound) as a focal treatment for the prostate.
But he contends that the advantages of the TULSA-PRO procedure are that it is done transurethrally, and that each localized tumor can be treated. The procedure is performed under constant real-time MR imaging, so that heat generation is accurately monitored throughout the entire treatment.
“With the TULSA-PRO, we preserve the rectal wall and the neurovascular bundle, and provide intra-urethral cooling which ensures the preservation of the urethral wall,” Dr. Lumiani explains. As a result, a patient’s anatomical structures and their functions, which run through the prostate, can be preserved.
Dr. Lumiani uses TUSLA-PRO for focal therapy of localized prostate cancer and for other diseases of the prostate.
“As a radiologist who has seen the advantages of MRI diagnostics for over 30 years, it is a great medical advancement to be able to offer our patients an MRI-guided prostate treatment,” he contends. “These prostate treatments are monitored by MRI the entire time. That means that the whole procedure, from the examination, to the biopsy, and straight to the treatment are MRI-guided in our clinic.”
In the future, Dr. Lumiani suggests that the radiologist and the urologist will work in closer collaboration. The radiologist provides the attending urologist with the diagnostic findings of the prostate, and the urologist then decides on how to proceed. Fusion biopsy, which is based on MRI diagnostics, will certainly be used more often in the future as well.
“Optimized MRI diagnostics, and the application of these methods, enables prostate tumors to be detected more often, and at the earlier stages than in the past,” he says.
“Overall, a greater number of patients receive maximum diagnostic certainty and their treatments can be customized precisely to their own needs, ensuring the best possible outcomes.”
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Ventripoint Diagnostics Ltd. (TSX-V: VPT) today announced that it has closed its previously-announced non-brokered private placement of 10,496,938 units at $0.32 per Unit for total gross proceeds of $3,359,020. Existing shareholders subscribed for $1.9M and new shareholders subscribed for $1.4M of the private placement. Each Unit consists of one common share of Ventripoint and one common share warrant, with warrant entitling the holder thereof to acquire one common share at a price of $0.50 per common share for a period of two years after the issuance of the warrant. Ventripoint intends to use the proceeds of the private placement for product development, sales and marketing and general working capital purposes.
"All of us at Ventripoint are thankful to our existing and new shareholders for providing the funding we needed to fully commercialize the VMS-PLUS™ heart analysis system. With these resources, we can market the VMS-PLUS and begin to improve the examination of patients with suspected or known heart disease." - Dr. George Adams, Chief Executive Officer.
Dr. George Adams, the Chief Executive Officer and a Director of the Corporation, subscribed for 312,000 units in the private placement. Such subscription constitutes a Related Party Transaction within the meaning of Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") and Policy 5.9 - Protection of Minority Security Holders in Special Transactions of the TSX Venture Exchange. The Corporation is relying on exemptions from the formal valuation and minority shareholder approval requirements available under MI 61-101. A material change report in respect of the Related Party Transaction will be filed by the Corporation but could not be filed earlier than 21 days prior to its completion due to the fact that the transaction is still subject to confirmation by the TSX Venture Exchange of the suitability of the acquirer of the insider units.
For further details, read the Company's full news release here.
Ventripoint Receives Approval for World's First Complete Heart Analysis System for 2D Ultrasound Exams
Ventripoint Announces Closing of Shares for Debt and New Closing Date for Private Placement
Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Corporation") (TSX-V: VPT) is pleased to announce that it has completed its previously-announced, shares-for-debt transaction (the "Shares for Debt") with holders of debentures previously issued by the Corporation (the "Debentures"). The Corporation issued to the holders of Debentures a total of 1,575,000 units of the Corporation ("Units") as payment of $504,000, being the aggregate of all amounts due under such Debentures. Each Unit consists of one common share of Ventripoint ("Common Share") and one Common Share purchase Warrant ("Warrant"), with each Warrant entitling the holder to acquire one Common Share at a price of $0.50 for a period of 2 years after the issuance of the Warrant.
The Corporation also announces that the previously-announced private placement of Units (the "Private Placement") has over 80 subscribers and the Corporation is working to complete all the paperwork to close on or before March 24, 2017. The Private Placement is subject to the final approval of the TSXV. For further details of the Private Placement, please see the Corporation's news releases of March 9, 2017 and March 15, 2017.
Dr. George Adams, the Chief Executive Officer and a Director of the Corporation, received 312,500 Units pursuant to the Shares for Debt. Such participation in the Shares for Debt constitutes a Related Party Transaction within the meaning of Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") and Policy 5.9 - Protection of Minority Security Holders in Special Transactions of the TSX Venture Exchange (the "TSXV"). The Corporation is relying on exemptions from the formal valuation and minority shareholder approval requirements available under MI 61-101. A material change report in respect of the Related Party Transaction will be filed by the Corporation but could not be filed earlier than 21 days prior to its completion due to the fact that the transaction was subject to approval by the TSXV.
Ventripoint announced earlier this month that it had received a license from Health Canada for the new VMS-PLUS™ machine and the 4-chamber (4C) heart analysis system. The VMS is already licensed in Canada for use for the right ventricle (RV). This expansion allows the determination of volume and function for all four chambers of the heart using conventional 2D ultrasound.
co-founder and CEO, enkateswarlu Nelabhotla (N. Venkat)
Closely-held Vyome Biosciences expects to enroll the final patient next month in a proof-of-concept clinical trial of its lead molecule for drug-resistant acne, VB 1953.
“Our product has the potential to be the first bactericidal antibiotic and anti-inflammatory topical gel for acne,” Venkateswarlu Nelabhotla (N. Venkat), co-founder and CEO, says in an interview with BioTuesdays. “We are the only company globally to address the issue of antibiotic resistance for skin pathogens.”
Vyome was established in 2011 to develop novel drugs for fungus infections in the scalp, but is now focused on developing molecules for drug-resistant skin infections.
In addition to acne, Mr. Venkat says Vyome has a deep pipeline of antibiotics, known as Dual Action Rational Therapeutics (DARTs) for multiple indications and a strong pipeline of clinically proven anti-fungal products based on Molecular Replacement Therapeutics (MRT). Nine patent groups, with some 300 patent applications filed globally, cover the company’s IP.
Only four antibiotics have been approved for the treatment of inflammatory acne in the U.S., of which clindamycin-based products are the most commonly used topically.
However, one-in-three people are resistant to clindamycin. “There has been very little innovation in this space for many years, making it a major unmet medical need, with a large and growing market,” he contends.
according to Mr. venkat, there is an unmet need and a growing market for antibiotic-resistant propionibacterium acne
Asked what differentiates VB 1953 from approved anti-acne medications, Mr. Venkat cites the anticipated patient response rates based on preclinical models; good anti-inflammatory properties; and “given the nature of the molecule and what we’ve seen in in vitro studies, we believe the probability of resistance developing in Propionibacterium acne is very, very low.”
Acne affects 240 million people globally. Some 100 million suffer from antibiotic-resistant acne, of which more than 10 million are in the U.S. alone.
“We are looking to address a potential $2-billion market for drug-resistant acne,” he points out. In addition, the same pipeline also addresses a $1.6-billion market of implant-related infections caused by Staphlococcus epidermidis, he adds.
In preclinical and in vitro studies, he says VB 1953 demonstrated excellent efficacy against antibiotic-resistant and-sensitive strains of Propionibacterium acne.
In January, Vyome released top-line results from a two-week Phase 1 study of VB 1953. The topical gel exhibited a promising dermal safety signal; was generally well tolerated, along with very low plasma concentrations; and displayed potential early signs of efficacy, with an early reduction in acne inflammatory lesions.
“These data are encouraging for patients with moderate-to-severe acne,” Mr. Venkat says.
Also in January, Vyome began enrolling up to 180 patients in a 12-week proof-of-concept clinical study of VB 1953 and expects to complete enrollment next month, with a data read out in August this year. The double-blind, randomized study will measure three efficacy endpoints: the number of patients with two points improvement in Investigator’s Global Assessment and a reduction in inflammatory and non-inflammatory acne lesion counts.
Vyome also plans to initiate a U.S. Phase 2b efficacy trial in the fourth quarter this year.
Beyond VB 1953, Vyome is developing a new generation of antibiotics, called DARTs, which have dual mechanisms of action against skin opportunist pathogens, making them candidates against the development of future resistance.
Last December, Vyome presented two posters at the Re-Entering Antibacterial Discovery and Development Summit in Boston. One detailed how its DARTs may have the potential to bypass and/or suppress antibiotic resistance for severe infections caused by orthopedic implants stemming from Staphylococcus epidermidis.
VB 1953 - PHASE 1 RESULTS SUMMARY
The second poster detailed the potential of Vyome’s library of novel antibiotics for skin opportunist pathogens and their low propensity to develop antibiotic resistance.
With its understanding of functional genomics, Vyome also has developed an advanced anti-fungal platform technology, known as Molecular Replacement Therapeutics (MRT), which not only impacts enhanced fungal killing ability to a known agent, but also allows for higher retention in deeper layers of the skin.
Mr. Venkat explains that MRT represents a novel way of changing the milieu of the fungi, which in turn disrupts the fungal membrane. “This technology can significantly enhance the efficacy of anti-fungal products,” he adds.
The company has commercialized two over-the-counter anti-dandruff products based on the MRT platform: a leave-on lotion and wash-off shampoo, and is in early development of a ketoconazole emulsion gel to treat skin Seborrheic dermatitis.
The program also includes several anti-fungal creams/lotions to treat recalcitrant Tinea infections, such as ringworm, athlete’s foot and jock itch.
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DiaMedica Announces Issuance of European Composition of Matter Patent and Additional Worldwide Filings for DM199
MINNEAPOLIS, Minnesota--(Marketwired) - DiaMedica Therapeutics Inc. (TSX VENTURE:DMA)(DMCAF), today announced that the European Patent Office has issued European Patent No. 2854841, entitled "Human Tissue Kallikrein 1 Glycosylation Isoforms". This patent contains claims that cover the composition of matter of DiaMedica's product candidate, DM199, and pharmaceutical compositions comprising DM199. The patent protects key composition of matter of DM199's proprietary recombinant kallikrien protein. The patent has an expiration date of 2033, which does not include any potential patent term extension.
The expanded patent protection adds European protection to DiaMedica's intellectual property portfolio related to DM199 that includes U.S. Patent No. 9364521 which provides expanded composition of matter protection for DM199.
DiaMedica also recently filed new worldwide patent coverage, including in the U.S., Europe, China and Japan for dosing, route of administration, formulation and for numerous indications that would expire in 2037. The filings was based on recent clinical trial results and related matter.
"We are delighted to announce the issuance of the composition of matter patent in Europe for DM199, which we believe affords broad, foundational composition of matter protection for our compound," commented Rick Pauls, President and CEO of DiaMedica. "We plan to continue to expand and fortify our intellectual property estate for DM199 via expanded worldwide patent coverage including in the U.S., Europe, Japan, and China. We also continue to maintain proprietary manufacturing know-how and trade secrets as we advance DM199 into Phase II clinical trials starting in the upcoming months."
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". For more information, please vist www.diamedica.com.
Jon Lieber, cfo
Histogenics (NASDAQ:HSGX) expects to complete enrollment by the end of the second quarter this year in a Phase 3 clinical trial of its NeoCart biologic cell therapy and tissue engineering solution for knee cartilage regeneration.
“We believe that if we are successful in this Phase 3 trial, we have the potential to become the new standard-of-care in knee cartilage regeneration,” CFO, Jon Lieber, says in an interview with BioTuesdays.
“We believe that NeoCart is the only product on the market or in development that has a one-year primary endpoint for marketing approval, compared with other products, which based on available data, do not appear to show a difference to microfracture surgery, the standard of care, until well beyond one year,” he adds. “One-year superiority would represent a significant marketing advantage.”
In an earlier 30-patient Phase 2 study, NeoCart demonstrated a statistically significant response, compared with microfracture surgery, for relieving pain and improving joint function in patients with knee cartilage defects within one year of surgery, with 76% of NeoCart patients responding, compared with 22% for microfracture. Long-term follow up pointed to a positive trend persisting for at least five years following surgery.
according to lieber, Cartilage injury causes pain and loss of function, leading to lengthy unsatisfactory surgeries, or debilitating conditions later in age
Mr. Lieber explains that NeoCart is manufactured using the company’s proprietary tissue engineering platform that combines the patient’s own cells with the company’s scaffold, bioengineering and bioadhesives to create tissue ex vivo that is designed to mimic and integrate with the surrounding tissue after implantation into the knee.
In addition, he points out that NeoCart is a biologic, not a medical device, so the “regulatory pathway, clinical trial design and manufacturing process and know how represent significant barriers to potential competitors.”
Beyond knee cartilage injury, Histogenics believes that the NeoCart platform can be developed to treat defects at other joints, such as the ankle, shoulder, hip and toe, as well as other tissue types, such as ligaments and tendons.
Mr. Lieber suggests that existing surgical procedures and therapies require extensive recovery time, impede return to normal function and are often ineffective over the long term.
First line therapy for cartilage injury usually begins with orthoscopic debridement, which involves shaving the edges of bone and removal of loose cartilage. The procedure reduces pain but does not repair cartilage and often leads to a second procedure, microfracture surgery, which involves perforation of bone at the site of the lesion to stimulate cartilage regrowth. However, microfracture often results in lengthy rehab and variable outcomes. Some 30% of microfracture patients will require reoperation within two years.
“We have the potential to offer patients pain reduction and cartilage regeneration, with accelerated rehab and durable outcomes; physicians a fast and easy procedure, with favorable reimbursement and less time in the operating room; and payers a lower reoperation rate, with costs expected to be competitive with other autologous cell-based products on the market,” Mr. Lieber contends.
In addition, he says NeoCart has potential advantages, such as the one-year primary endpoint and focus on the smaller-lesion microfracture standard of care market over cell-based products now on the market, such as Vericel’s Carticel and MACI, a second-generation product, approved by the FDA last December.
Carticel is currently used as second-line rescue therapy following the failure of microfracture or other procedures. Unlike NeoCart, Carticel therapy injects a mixture of a patient’s chondrocytes into the site of injury and seals them using a covering, which can result in a more complicated surgery of one-to-three hours, compared with 30 minutes or less for NeoCart, as well as a longer recovery period and more varied results.
In addition, two common side effects of Carticel treatment are insufficient healing and bone overgrowth, which can lead to pain and joint stiffness. Mr. Lieber points out that no patient showed evidence of tissue overgrowth or knee stiffness in Histogenics’ previous Phase 1 and 2 studies.
neocart is designed to offer a complete solution for cartilage repair
In January, investigators published MRI and clinical outcomes data from NeoCart’s Phase 1 and 2 clinical trials in the American Journal of Sports Medicine. The data demonstrated significant improvement in cartilage quality over the first 24 months after treatment, with stabilization and maturation out to 60 months. In addition, improvements in cartilage quality were accompanied by consistent and statistically significant improvements in patient-reported clinical outcomes as early as three-to-six months after implantation, as compared to baseline.
According to Mr. Lieber, there is a strong correlation between untreated cartilage loss and osteoarthritis or total knee replacement. “We are targeting NeoCart to younger, healthy and active adults, with repetitive knee trauma and acute cartilage injury.”
Histogenics estimates that knee cartilage defects represent a significant market opportunity in the U.S., with an estimated 500,000 or more applicable corrective procedures each year.
Mr. Lieber points out that the company’s Phase 2 study originally was designed to be an exploratory study, but the “strong data we obtained encouraged us to seek approval to move directly into a Phase 3 trial with a similar trial design.”
Like the Phase 2 study, Histogenics’ Phase 3 trial intends to evaluate whether NeoCart can outperform standard-of-care microfracture in improving patient pain and physical functions, as assessed by Knee injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) score, at one year. Secondary endpoints include time to full weight bearing, reoperation rates and MRI analysis.
The Phase 3 trial, which is being conducted under a special protocol assessment from the FDA, will require an approximate 15-to-20-percentage point difference in responders between NeoCart and microfracture, he adds.
neocart phase 3 clinical trial
Histogenics is enrolling 245 patients in the Phase 3 trial, with 163 in the NeoCart treatment arm and 82 receiving microfracture. At the end of 2016, enrollment had reached 190-to-200 patients, with completion expected by the end of the second quarter.
“We believe this is the largest ever prospective trial of cartilage repair conducted in the U.S.,” Mr. Lieber contends, noting that so few products have been developed in the field because “historically, these trials have been difficult to enroll. The FDA wants to be sure that pain relief resulted from cartilage repair, not other corrective treatments.”
If the trial is successful, Histogenics hopes to file a Biologics License Application (BLA) in mid-2018, with possible marketing approval in the first half of 2019.
Mr. Lieber says Histogenics plans to build a scalable U.S. commercial infrastructure for NeoCart, with 40-plus sales reps, targeting high prescribing orthopedic surgeons. The company also will employ a small staff of medical liaison reps. Due to the ease of the NeoCart procedure, the company can target large sports medicine surgeon markets with a small commercial infrastructure.
Outside the U.S., the company plans to partner the sales and marketing of NeoCart, initially in Japan. “We have been holding talks with the Pharmaceuticals and Medical Devices Agency in Japan and hope to share that feedback in the first half this year, which we expect will lead to discussions with potential partners,” he adds.
Mr. Lieber says that the company has a production-ready strategy and believes its fully integrated manufacturing facility in Massachusetts combined with the Phase 3 trial, which has the same design as the Phase 2 trial, have the potential to de-risk its BLA filing. The facility has state-of-the-art biologics, biomaterials and cell therapy capabilities.
“The expansion plan is also scalable so that for $10-million of capital, each additional manufacturing module has the potential to generate $75-million of revenue,” he adds. “Expansion will be based on demand but we have a modular strategy in place that matches up nicely with our regulatory strategy.”
Last year, Histogenics and Intrexon generated proof-of-concept data for next- generation, one-step allogeneic cartilage products to accelerate manufacturing and pipeline initiatives through a master cell line. “The data demonstrated our ability to make induced pluripotent stem cell-derived implants as measured by the same cartilage biomarkers as NeoCart,” Mr. Lieber says.
The companies plan to meet with the FDA or other regulatory authorities this year to establish a development pathway.
In December, Swayampakula Ramakanth, an analyst with H.C. Wainwright, initiated coverage of Histogenics at “buy” with a price target of $3.50, saying that if the Phase 3 results hold up, NeoCart has the potential to become the best-in-class cartilage restoration treatment and replace microfracture as the first-line treatment of choice for knee cartilage injury. The stock closed at $1.84 on Friday.
“NeoCart may offer the potential for accelerated patient recovery, improved efficacy, a better safety profile, and can be used by more patients,” he added.
NEOCART PHASE 3 CLINICAL TRIAL BASED ON SUCCESSFUL PHASE 2 TRIAL
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DiaMedica Presents Updated Positive DM199 Phase 1b Trial Identifying A Superior Subcutaneous Delivery Profile
MINNEAPOLIS, Minnesota, March 13, 2017 /Marketwired/ -- DiaMedica Therapeutics Inc. (the "Company") (TSX-V: DMA) (OTCQB: DMCAF), a clinical stage biopharmaceutical company developing synthetic protein treatments for neurological and kidney diseases, reported positive results from its Phase 1b bridging trial. The study was designed to compare the profile of DM199 to the approved urinary KLK1 product (trade name Kailikang®) on the market in Asia for acute ischemic stroke. The reference drug is administered intravenously and has a very short half-life. The DiaMedica study identified an intravenous dose of DM199 having a similar profile to urinary KLK1.
Today the Company is reporting an improved subcutaneous dose of DM199 producing sustained plasma levels superior to the reference drug. The Company plans to use the results of this study to guide Phase II dosing in upcoming clinical trials.
The DM199 subcutaneous delivery provides sustained levels of the KLK1 protein, offering a potentially superior profile to the reference drug, which has a very short exposure window. The dosing of DM199 will be significantly more convenient and potentially provide improved efficacy to the short half-life of the reference drug. DM199 has the same amino acid sequence as the reference drug, identical biochemical activity, and demonstrated similar physiological effects.
"We are very pleased to have identified an intravenous dose of DM199 that mimics the currently approved version of the drug and a new subcutaneous delivery option that could provide sustained therapeutic levels of DM199 for acute ischemic stroke," said Dr. Todd Verdoorn, Chief Scientific Officer of DiaMedica. "This study identified what we believe is an optimal dosing of DM199, fully supporting upcoming Phase II trial in stroke patients."
The Phase 1b controlled trial tested DM199 in 36 healthy volunteers, who received either one of four 30-minute intravenous infusions or a single subcutaneous injection. Plasma DM199 concentration, biomarker concentrations, and other safety and pharmacokinetic parameters were measured in the trial.
No treatment-limiting adverse events were reported in any dose group. The Company plans to publish the full results of the study in a peer reviewed journal.
DM199 is a recombinant (synthetic) human tissue kallikrein ("KLK1") protein to treat neurological and kidney diseases. DiaMedica has completed five clinical trials with DM199, including single ascending and multiple ascending doses, studies in diabetic patients, and the current bridging study. In addition to a good safety and tolerability profile, DM199 showed the anticipated activity, lowering blood pressure over the course of treatment in multiple clinical studies. In a recent preclinical study, DM199 significantly increased cerebral blood flow.
About KLK1 in Asia
Two forms of the KLK1 protein are approved in Asia for the treatment of acute ischemic stroke and diabetic nephropathy (diabetic kidney disease). A human urinary KLK1 (Kailikang®) protein and a porcine KLK1 (Kallidinogenase) protein have been approved in Asia for acute ischemic stroke, diabetic nephropathy, hypertension, and retinopathy. DiaMedica estimates over 200,000 patients are treated each year with the two forms of the KLK1 protein in Asia with total estimated sales of over $200 million U.S.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". For more information, please visit www.diamedica.com.
Dr. Terrence Norchi, president and CEO
Arch Therapeutics (OTCQB:ARTH) has multiple regulatory filings planned in the U.S. and Europe this year for its AC5 Topical Hemostatic Device as the biopharma company shifts to regulatory-stage footing ahead of commercialization.
“While we see a path to commercialization of AC5, we expect to remain a clinical-stage company as we develop subsequent products in our pipeline,” Dr. Terrence Norchi, president and CEO, says in an interview with BioTuesdays.
On the drawing board for 2017 is a filing for CE Mark approval in Europe, a 510(k) filing in mid-2017 for topical use in the U.S. and an investigational device exemption (IDE) filing in the U.S. to conduct a surgical trial for premarket approval (PMA) to use AC5 for internal use.
Dr. Norchi explains that AC5 is typically applied as a clear free flowing solution of self-assembling peptides that forms a scaffold or mesh gel of nanofibers within seconds of exposure to the ions naturally present in all bodily fluids, including blood, cerebrospinal fluid, and interstitial fluid.
Unlike many competitive products, he says AC5 conforms to irregular wound geometry, forming a barrier to achieve hemostasis, which then allows for normal healing while maintaining a clear field of vision directly into the wound area. Because it is not sticky or glue-like, it could be ideal for use in a range of open and closed procedures, he adds.
Arch’s preclinical pipeline includes several product applications with high medical need, including care of chronic cutaneous wounds and burns, prevention of surgical adhesions, sealing gastrointestinal anastomoses and ophthalmology. “We’ll advance the best product candidate where we see the most potential,” he suggests.
“Bleeding presents a significant clinical and economic burden. Any hole made in the body must be properly sealed and managed to allow for normal healing,” he adds.”
Bleeding also poses problems in surgical procedures and trauma, with loss of visual field and increased error risk, Dr. Norchi points out. Patients on anticoagulants and antiplatelet agents, also known as blood thinners, or those with co-morbidities, such as diabetes and renal disease, also are at increased bleeding risk.
“In our first clinical trial, AC5 has demonstrated it can establish a hemostatic barrier even in a patient taking blood thinners,” he contends.
dr. terrence norchi says, AC5 conforms to irregular wound geometry, forming a barrier to achieve hemostasis, which then allows for normal healing while maintaining a clear field of vision directly into the wound area
Arch licensed the worldwide rights to the technology behind AC5 from MIT in Cambridge, MA. When adding patents covered by the license to its own patents and patent applications, Arch currently has more than 40 patients granted and pending to protect its intellectual property.
Dr. Norchi believes that existing products, such as gelatin, collagen, cellulose, polymers, thrombin and fibrin sealants, do not present ideal solutions to stop bleeding.
He says these products can be associated with a range of challenges, including unreliability, slow onset of action, handling restrictions, infections, negative inflammatory responses and healing problems. Some of the products can cost approximately $500 per application.
Many of the currently marketed products can take up to several minutes to stop bleeding, compared with often less than 30 seconds for AC5.
“What physicians want in a hemostatic barrier device is something that works quickly, easily, broadly and safely,” he points out, noting that this is the solution offered by AC5. “Data to date supports that our AC5 is biocompatible – or safe - and the amino acids that it is made of are themselves made synthetically, rather than derived from humans or other animals.”
Last August, Arch reported results from its first clinical trial in humans, which met its primary and secondary endpoints. The study was conducted in Ireland with 46 patients, 10 of whom were on blood thinners. Each patient had two freshly excised, or bleeding, skin lesions: one treated with AC5 and one control lesion treated with saline.
Specifically, the median time to hemostasis of wounds in the AC5 treatment group, including those on blood thinners was less than 30 seconds, which was a statistically significant 41% faster than for those in the control group. Notably, the control lesions on patients taking blood thinners took more than three times longer to stop bleeding.
Dr. Norchi says the company is working on a next generation kit that would contain prefilled syringes, compared with the current AC5 powder that must be mixed.
Arch’s plan is to file for CE Mark approval as soon as possible this year. A 510(k) filing for topical use of AC5 in the U.S. has been advanced to mid-2017 from the earlier plan of late-2017.
The company also expects to file an investigational device exemption with the FDA this year for an AC5 surgical trial in order to obtain premarket approval (PMA) of the device for internal use.
"Our anticipated 510(k) filing focusing on external skin applications should present a nearer-term opportunity for AC5, compared with our previous plan of filing a PMA for all uses in the U.S.,” Dr. Norchi says.
“We anticipate that the potential benefit from an earlier 510(k) filing is significant in terms of business opportunity and technology validation,” he adds. “Our intent to file a PMA for internal use after completing the necessary human clinical work also remains intact."
Industry analysts suggest that the $3-billion global hemostat market, which is dominated by a relatively small number of global firms, will double over the next seven years.
“We believe those firms will be increasingly attracted to, if not threatened by, Arch’s AC5 hemostat as it continues to develop,” Roth Capital Partners analyst, Michael Higgins, wrote in an initiation report last month. He believes that AC5 has the potential to “revolutionize the hemostat market.”
Mr. Higgins rates Arch shares at “buy” with a 12-month price target of $3. The stock closed at $0.63 on Friday.
pipeline potential: stasis and barrier applications - opportunities for arch and/or potential partners
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Ventripoint Receives Approval for World's First Complete Heart Analysis System for 2D Ultrasound Exams
Today, Ventripoint Diagnostics Ltd. (TSX VENTURE: VPT) announced that it had received a license from Health Canada for the new VMS-PLUS™ machine and the 4-chamber (4C) heart analysis system. This is an expansion of the VMS heart analysis product to include right atrium (RA), left atrium (LA) and left ventricle (LV) chambers of the heart. The VMS was already licensed in Canada for use for the right ventricle (RV). This expansion allows for the determination of volume and function for all four chambers of the heart using conventional 2D ultrasound, which could only be provided by MRI until now.
"Ventripoint has achieved a "world first" with the approval of a whole-heart analysis system for 2D ultrasound exams, which provides accurate and reliable measurements equivalent to MRI," stated Dr. George Adams, CEO of Ventripoint. "I am excited to begin to market our 4C machine and generate value for our shareholders. With the license in Canada, Ventripoint now has "home-country approval", which simplifies the registration process for VMS products in many countries. This is exactly what we've been striving for."
The size and function of all four chambers of the heart is increasingly recognized as critically important in monitoring patients' responses to cardiac medications and procedures and predicting outcomes This information is often unavailable as access to cardiac MRI is very limited in many countries, including Canada. 2D cardiac ultrasound is universally available worldwide and with the VMS-PLUS generates measurements equivalent to MRI. This simple combination makes it possible to obtain this valuable information at every cardiology appointment in a few minutes.