|Flexion Awarded Approximately $2 Million to Conduct Clinical Trial of FX006; Arena Reports Favorable Results of APD371|
|By William Kent|
|Wednesday, 29 April 2015 22:47|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 29, 2015.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced the U.S. Department of Defense ("DoD") awarded the company a grant1 worth approximately $2 million to conduct a Phase 2 clinical trial investigating FX006 as treatment for osteoarthritis ("OA") pain in active military and medically retired veterans with post-traumatic OA of the knee. FX006 is a steroid, triamcinolone acetonide or TCA, formulated for sustained-release, delivered by intra-articular ("IA" or "in the joint") injection for patients with OA pain of the knee. Flexion announced in February that dosing had begun in a Phase 3 clinical trial of FX006 as a treatment for pain associated with OA of the knee.
"We are pleased that the U.S. DoD has awarded Flexion a grant to study FX006 in military personnel and veterans who have experienced trauma to the knee and are looking for potentially better options to manage pain related to their knee OA," said Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We are honored to be working toward meeting the medical needs of our U.S. soldiers and to have the agency's support to further investigate our lead drug candidate in this capacity."
The DoD-funded trial is a single-center, double-blind, randomized, parallel group, proof-of-concept study, which plans to enroll a total of 124 male and female active and former service members between the ages of 20 and 45 years. The primary objective of this study will be to assess the analgesic effect of a single IA injection of 40 mg of FX006 relative to commercially available immediate-release TCA in active military and medically retired patients with moderately symptomatic post-traumatic OA of the knee. The primary endpoint is the average change from baseline in the weekly mean of the average daily (24-hour) pain intensity scores over weeks 5 to 10. The study is also designed to assess the effect of FX006 on function, responder status, global impressions of change, stiffness and consumption of analgesic medications and to assess the safety and tolerability of a single IA injection of 40 mg FX006 relative to commercially available immediate-release TCA.
About FX006 -- FX006 is a first-in-class injectable, sustained-release, IA steroid treatment for patients with moderate to severe OA pain. FX006 was specifically designed to address the limitations of current IA therapies by providing long-lasting, local analgesia while avoiding systemic side effects. To date, over 440 patients have been treated with FX006. In a completed Phase 2b dose-ranging clinical trial, FX006 has demonstrated clinically meaningful and significantly better pain relief compared to the current injectable standard of care, TCA. In two Phase 2a synovial fluid pharmacokinetic studies, a single IA injection of FX006 demonstrated therapeutic concentrations of drug in joint fluid for at least 12 weeks. FX006 is currently being studied in pivotal Phase 2b and Phase 3 clinical trials, which are designed to provide the required data for FX006 to be submitted for regulatory approval by the U.S. Food and Drug Administration.
Arena Pharmaceuticals (NASDAQ: ARNA) announced favorable results from a Phase 1 single-ascending dose clinical trial of APD371, a highly selective and potent agonist of the cannabinoid 2 (CB2) receptor currently in development for the treatment of pain and potentially fibrotic diseases.
The randomized, double-blind and placebo-controlled Phase 1 clinical trial enrolled 56 healthy adults to evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of APD371. Dose responsive exposure was observed over the explored dose range of 10-400 mg with good tolerability at all doses administered.
"In this trial, APD371 was well tolerated, as evidenced by the lack of dose-limiting adverse events, at drug levels greatly exceeding those anticipated as needed for activating the CB2 receptor," said William R. Shanahan, Jr., M.D., Arena's Senior Vice President and Chief Medical Officer. "We believe that the intrinsic properties of this compound could offer advantages over currently marketed treatments for pain."
About APD371 -- APD371, an orally available agonist of the CB2 receptor, is Arena's internally discovered investigational drug candidate for several potential indications, including pain and fibrotic diseases. This compound, through its high level of observed selectivity for the CB2 receptor versus the CB1 receptor, is designed to provide pain relief without psychotropic effects or the potential for dependence or abuse. Preclinical efficacy with APD371 has been shown in animal models of osteoarthritic and neuropathic pain.
Acasti Pharma Inc. (Nasdaq:ACST ) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces the departure of André Godin as Chief Financial Officer of Acasti effective immediately.
BioTelemetry, Inc. (Nasdaq:BEAT) will release its first quarter 2015 earnings on Wednesday, May 6, 2015 at 4:00 PM Eastern Time.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that a member of the company's senior management team will participate in the following investor conferences in May and June 2015.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that Leslie V. Norwalk, Esq., will be joining the Endologix Board of Directors effective May 1, 2015.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of updated clinical data from the Company's EVAS FORWARD – Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms ("AAAs") who were treated with the Nellix® EndoVascular Aneurysm Sealing System.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider group practice, today announced financial results for the first quarter ended March 31, 2015.
The Joint Corp. (Nasdaq: JYNT), a national healthcare franchisor of chiropractic clinics, today announced that it will release its 2015 first quarter financial results on Thursday, May 14, 2015, at 4:00 p.m. ET, with a conference call to follow at 5:00 p.m. ET.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) announced today that the U.S. Food and Drug Administration (FDA) has approved KYBELLA™, also known as ATX-101, "for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults." KYBELLA™ is the first and only approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition.
Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced the closing of an underwritten public offering of 5,347,500 shares of its common stock at $6.50 per share.
LifeVantage Corporation (Nasdaq:LFVN), announced today that Darren Jensen has been named President and Chief Executive Officer for the company. Mr. Jensen's appointment is effective May 18, 2015.
MedAssets, Inc. (Nasdaq:MDAS) today announced results for its first quarter ended March 31, 2015.
MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces that a poster presentation highlighting the positive clinical results achieved using NexoBrid™ as an effective enzymatic debridement for severe burns, titled "Early enzymatic debridement of deep dermal burns – first results in hands and preliminary results in face and lower extremity," was awarded "Best-in-Category in Wound Care Practice" among the hundreds of posters presented at the recent American Burn Association 47th Annual Meeting (ABA 2015).
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced that it will provide an online Web simulcast of its 2015 first quarter conference call on Friday, May 8, 2015.
NeoStem, Inc. (Nasdaq:NBS), a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced today the randomization of the first patient in the Intus Phase 3 clinical trial investigating the efficacy of the Company's patient-specific targeted cancer immunotherapy candidate NBS20 (USAN = eltrapuldencel-T) in patients with stage III recurrent or stage IV metastatic melanoma.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), today provided a business update.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), today presented new discoveries related to the company's anti-cancer immuno-oncology pipeline during the company's first Research and Development (R&D) Day for analysts and investors.
Revance Therapeutics, Inc. (Nasdaq:RVNC), a specialty biopharmaceutical company developing botulinum toxin products for the use in aesthetic and therapeutic indications, announced today that the Company will release first quarter 2015 financial results on Wednesday, May 13, 2015 after the close of market.
StemCells, Inc. (Nasdaq:STEM) today announced that it has closed its previously announced offering of common stock and warrants.
Surgical Care Affiliates, Inc. (Nasdaq:SCAI) will present at the Bank of America Merrill Lynch 2015 Health Care Conference on Wednesday, May 13, 2015.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to participate in the Bank of America Merrill Lynch 2015 Health Care Conference being held at The Encore at Wynn Hotel in Las Vegas.
VBL Therapeutics (Nasdaq:VBLT) a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that management will present a company overview at the following conferences in May: Deutsche Bank 40th Annual Health Care Conference in Boston, MA on Wednesday, May 6, 2015, at 2:50 p.m. ET; Oppenheimer 16th Annual Israeli Conference, in Tel-Aviv, Israel on Sunday, May 10, 2015, at 1:10 p.m. IST (6:10 am ET); IATI Biomed 2015 Conference in Tel Aviv, Israel on Wednesday, May 13, 2015, at 2:20 p.m. IST (7:20 a.m. ET).
Wright Medical Group, Inc. (Nasdaq:WMGI) today reported financial results for its first quarter ended March 31, 2015.