|FDA Grants Fast Track Designation to Can-Fite's CF102; Merck Provides Diabetes Portfolio Update|
|By William Kent|
|Thursday, 17 September 2015 19:20|
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 17, 2015.
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) TASECFBI, a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.
Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.
Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug's development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.
"We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."
According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.
About CF102 -- CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, provided an update today on its diabetes portfolio and re-affirmed the company’s comprehensive, long-term commitment to patients with diabetes. Merck has a proud history in helping patients with type 2 diabetes. Since launching JANUVIA® (sitagliptin) in 2006 as the first DPP-4 inhibitor in the United States, Merck has continued to collaborate with academic and industry partners on advances in the care of patients with diabetes, and to research and develop innovative treatment options. At the 51st European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden, new Phase 3 data on Merck’s investigational once-weekly oral DPP-4 inhibitor, omarigliptin, and additional findings from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) of Merck’s once-daily DPP-4 inhibitor, JANUVIA, are being presented.
“At Merck, our priorities are driven by unmet medical need and our belief in Merck's ability to advance patient care, which is why diabetes remains a top priority. Our teams are focused on bringing forward both scientific insights and new treatment options that can help patients and physicians better manage the challenges of diabetes,” said Sam Engel, M.D., associate vice president, Merck clinical research, diabetes and endocrinology. “We have a strong portfolio of established medicines, and continue to strengthen our role in the future of diabetes treatment through our own research and development, strategic collaborations and acquisitions.”
Our flagship medicine, JANUVIA, was approved in 2006 in the United States and is now available in more than 127 countries worldwide. More than 83 million prescriptions of JANUVIAand JANUMET® (sitagliptin and metformin HCl) have been dispensed worldwide. The recent presentation of the results of TECOS—the CV safety trial of more than 14,000 patients with type 2 diabetes—has provided important new information on JANUVIA, and additional analyses of safety data from TECOS will be presented on Sept. 18, 2015 at the EASD Annual Meeting. The results of the TECOS CV safety trial will be submitted to the U.S. Food and Drug Administration (FDA) and other regulatory agencies this year.
Indications and Limitations of Use for JANUVIA® (sitagliptin) 25 mg, 50 mg and 100 mg tablets -- JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and the Gynecologic Oncology Group (GOG, now part of NRG Oncology), today announced clinical data from Stage 1 of an ongoing two-stage Phase 2 study (GOG-0265) of Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. The Stage 1 data showed that treatment with axalimogene filolisbac resulted in a 38.5 percent 12-month overall survival rate in 26 patients.
American CareSource Holdings, Inc. (NASDAQ:ANCI), a high-growth, urgent and primary care company operating under the name GoNow Doctors, announced today that its NADSAQ ticker will change to "GNOW". The new symbol is anticipated to become effective as of the opening of trading on Friday, September 18, 2015. "Aligning our stock symbol and brand name is a significant milestone in our plan to develop a premier urgent and primary care company," said Chairman and Acting Chief Executive Officer, John Pappajohn. As previously announced, American CareSource adopted "GoNow Doctors" as its urgent care brand name to effectively communicate its commitment to providing immediate access to comprehensive healthcare. "With our symbol change, we are now well positioned to deliver a clear and consistent message to both the investment public and to the growing number of patients we serve."
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced top-line results from the RayVa™ Phase 2a trial in patients with scleroderma who also suffer from Raynaud's phenomenon ("Raynaud's"). The primary objective of this clinical trial was to establish safety and tolerability and to look for pharmacodynamic effects in this targeted Raynaud's population. The RayVa Phase 2a trial was a randomized, double-blind, placebo-controlled trial that enrolled approximately thirty-five subjects across four U.S. sites. The clinical trial was based on an experimental design wherein subjects were exposed to a cold challenge to assess blood flow (hemodynamic) and skin temperature (thermodynamic) changes, by laser Doppler and thermography, as a result of the vasoconstriction characteristic of Raynaud's. In each case, subjects were exposed to a dose of placebo and a dose of one of three active doses, and served as their own control.
Authentidate Holding Corp. (Nasdaq:ADAT), has partnered with AEON Clinical Laboratories to nationally launch Cancer Detect Profile®, a 38-gene cancer genetic test coupled with telehealth-based genetic counseling for the prescribing physicians. The test is designed to identify patients with increased risk of colorectal, breast, pancreatic, ovarian, gastric, melanoma, stomach and other cancers. The test is now available for use by AEON's base of more than 6,000 physicians who annually treat more than one million patients nationwide.
Avant Diagnostics, Inc. (OTCQXB:AVDX) has engaged Goal Capital Inc. to provide a comprehensive strategic investor relations program on behalf of Avant. Goal Capital is an outsourced investor relations and consulting firm with experience in creating value and exposure for small- to mid-cap companies. Gregg Linn the President and CEO of Avant commented "We are thrilled that Goal Capital is part of our professional team. We continue to make progress toward Food and Drug Administration approval of OvaDx®, our proprietary diagnostic test for the early detection of ovarian cancer. Goal Capital has experience working with small cap health care/biotech companies and we welcome the opportunity to have Goal Capital assist us with telling our story to the investing public."
Dear Fellow Shareholder -- I am writing today to reintroduce you to BioCorRx, Inc. (OTCQB: BICX) and bring you up to date on our recent progress and our plans for the upcoming quarters. Since our corporate rebranding in January 2014, BioCorRx has completed a number of steps to establish our platform for sustainable, fast growth as a publicly traded company. Now we are preparing to reap the benefits of these efforts. Data from the National Institute on Drug Abuse suggests that some 23.5 million Americans have alcohol and/or opiate addiction issues. Of this group, an estimated 85% of people with alcohol abuse or dependence go untreated. Marketdata Enterprises sizes the U.S. addiction treatment market at $35 billion annually. As the ACA has expanded access to addiction treatment, healthcare providers and investors are looking to stake claims in this highly fragmented market.
Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today reported financial results for the fourth quarter and year ended fiscal 2015 and provided an update on its progress.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), today announced the presentation of preclinical data demonstrating the molecular rationale for the clinical development of CYC065, Cyclacel's second-generation cyclin dependent kinase (CDK) inhibitor, to treat hematological malignancies, including acute leukemias and lymphomas. The data showed that a range of CDK9-dependent acute myelogenous leukemia (AML) and diffuse large B-cell lymphoma (DLBCL) cell lines were sensitive to CYC065. The cell line panel represented different genetic characteristics of hematological malignancies correlating with poor prognosis, including MLL rearrangements (MLLr) and myc amplification or overexpression. CYC065 was also shown to combine effectively with standard cytotoxic agents, such as cytarabine, and with agents targeting apoptotic regulators, including Bcl-2 inhibitors, such as venetoclax (ABT-199/GDC-0199). The data were presented at the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting taking place September 16-19, 2015 in Houston, Texas.
DeGen Medical has received clearance from the FDA for its first cervical spine implant, Hyper-C™ Anterior Cervical Plate System. The Hyper-C™ system is an anterior intervertebral fixation device that is designed to aid in stabilizing the cervical spine. "Clinical research has shown that greater than 5mm distance (of the cervical plate) from adjacent discs equates to less adjacent level degeneration post-operatively. The small over-hang of Hyper-C™ plate is an evidence based approach to attain this outcome which may be extremely beneficial for patients in decreasing adjacent level disease*." - Dr. Rakesh Chokshi.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that it has appointed Vaseem Mahboob to the position of Chief Financial Officer, effective October 15, 2015. Mr. Mahboob succeeds Shelley Thunen, who is resigning as part of the Company's previously announced CFO transition.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB), announced today the approval by the Board of Directors for a Patient Assistance Program for the open-label AMP-511 study of Ampligen® in Chronic Fatigue Syndrome (CFS) patients. Recently the company announced the first increase in the cost of the drug in 17 years. The Patient Assistance Program will allow the patients currently on the open-label treatment protocol to continue to receive the drug, through March 2016, at the cost-recovery rate in effect when they entered the study.
The Joint Corp. (NASDAQ:JYNT), a national healthcare operator and franchisor of chiropractic clinics, today announced that Jim Amos and Richard Kerley will join the company's board of directors, expanding the board to a total of nine members. They will begin serving immediately. "Both Jim and Richard bring significant growth experience and multi-unit operating credentials to our board," said John B. Richards, chief executive officer of The Joint Corp. "Jim's extensive knowledge and experience of high growth franchise service businesses and of corporate strategy, along with Richard's vast financial experience and background in operations management, will serve us well as we execute on our national expansion plans. I'm confident that their skills, expertise and insights will provide tremendous value to our company."
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective antifungal and anti-bacterial therapeutics for the treatment of serious and life-threatening infections, today announced that it has appointed Peter G. Pappas, M.D., FACP, to its Scientific Advisory Board (SAB). Dr. Pappas, an internationally recognized expert in the treatment and diagnosis of invasive fungal infections, is the William E. Dismukes Professor of Medicine in the Division of Infectious Diseases in the Department of Medicine at the University of Alabama at Birmingham and the Principal Investigator for the Mycoses Study Group Education and Research Consortium (MSGERC) which performs multicenter trials, creates treatment guidelines for invasive mycoses, and coordinates training in the epidemiology, diagnosis and treatment of invasive mycoses. His expertise includes the development of new therapies for fungal infections and understanding the epidemiology of candidiasis, the endemic mycoses, and cryptococcosis. Over the last 25 years, Dr. Pappas has led numerous clinical trials in candidiasis, cryptococcosis, aspergillosis, sporotrichosis, blastomycosis, and histoplasmosis through his involvement with the National Institute of Allergy and Infectious Disease (NIAID) Bacteriology and Mycology Study Group (BAMSG) and the MSGERC.
Nasdaq (Nasdaq:NDAQ) announced that trading of REGENXBIO Inc. (Nasdaq:RGNX) commenced on The Nasdaq Stock Market on September 17, 2015.
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), today provided updates on the potential broad-spectrum, in vitro activity for omadacycline. Across seven microbiology studies omadacycline demonstrated in vitro activity against Gram-positive, Gram-negative, and atypical bacteria, including those with resistance to currently available antibiotics. The data are being presented at the joint meeting of the International Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) in San Diego, September 17 - 21. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. Omadacycline, Paratek's lead clinical candidate, is a once-daily oral and intravenous (IV), broad-spectrum antibiotic currently in Phase 3 development.
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP) announced today that Rick Matros, the Company's Chairman and Chief Executive Officer, Harold Andrews, the Company's Chief Financial Officer, and Talya Nevo-Hacohen, the Company's Chief Investment Officer, will be participating in the 25th NIC National Conference on September 30 to October 2, 2015 at the Gaylord National Resort and Convention Center in National Harbor, Maryland. Additionally, Mr. Matros will be participating in The Future of Permanent Debt Financing panel on October 1, 2015.
SANUWAVE Health, Inc. (OTCQB:SNWV), a leading shock wave technology company, today released a letter to its shareholders from company Chairman of the Board and Co-CEO Kevin A. Richardson, II. --- Dear Fellow Shareholders, I am writing today to share the exciting progress at SANUWAVE Health and detail our plans over the next few months. As you may recall, less than three months ago, SANUWAVE was facing two primary challenges: the preliminary results for our current study involving the treatment of diabetic foot ulcers did not meet its primary 12-week endpoint and we faced a balloon payment per our debt agreement with HealthTronics. In response, our team worked diligently to take on these challenges and I am happy to say that we've moved the Company into a much stronger position in just a short period of time and we've met or exceeded all milestones we established in recent communications.
Surgical Care Affiliates, Inc. (NASDAQ:SCAI) will present at the Deutsche Bank 23rd Annual Leveraged Finance Conference on Wednesday, September 30, 2015. Tom De Weerdt, Executive Vice President and Chief Financial Officer of SCA, will present at 8:00 a.m. MST / 11:00 a.m. EDT in Scottsdale, Arizona. A live audio webcast of the presentation, as well as a copy of the investor presentation for the conference, will be accessible on SCA's Investor Relations website at http://investor.scasurgery.com. An archived version of the webcast presentation will be available on SCA's Investor Relations website later that day.
VBL Therapeutics (NASDAQ:VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that complete Phase 2 data on VB-111 in combination with Bevacizumab (Avastin™) will be presented at the European Society for Medical Oncology's (ESMO) European Cancer Congress 2015, being held September 25th-29th in Vienna, Austria.
Signal Genetics, Inc. (NASDAQ:SGNL), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the appointment of Richard Bender, MD, FACP, as Chief Medical Officer, effective September 14, 2015. Dr. Bender will report to Samuel D. Riccitelli, the Company's President and Chief Executive Officer.
TG Therapeutics, Inc. (Nasdaq:TGTX) announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical trial for its proprietary combination of TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, plus TGR-1202, the Company's once-daily PI3K-delta inhibitor, for the treatment of Chronic Lymphocytic Leukemia (CLL). The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the regulatory submission for drug approval of both TG-1101 and TGR-1202 in combination.
Zecotek Photonics Inc. (TSX-V:ZMS) (Frankfurt:W1I) (OTCPK:ZMSPF), a developer of leading-edge photonics technologies for medical, industrial and scientific markets, is pleased to announce that the University of California at Davis has successfully tested its patented LFS scintillation crystals in a new cutting edge approach for positron emission tomography (PET) scanning.