|Soligenix Announces FDA Protocol Clearance of SGX203; Biogen Reports New Anti-LINGO-1|
|By Marilyn Mullen|
|Tuesday, 14 April 2015 19:20|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 14, 2015.
Soligenix, Inc. (OCTBB: SNGX), announced an agreement has been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating its product, SGX203 (oral beclomethasone 17,21-dipropionate or BDP), in the treatment of pediatric Crohn's disease. SGX203 has previously been granted both orphan drug and fast track designations from the FDA for the treatment of Crohn's Disease in the pediatric population.
SGX203 is a proprietary formulation of BDP that uses a two-tablet immediate and delayed release system to orally deliver high mucosal concentrations of the topical steroid to both the upper and lower bowel walls. This makes SGX203 particularly well suited for Crohn's disease in younger patients that are reported to have gastrointestinal (GI) inflammation in both areas of the bowel as opposed to adults who have mainly lower (colon) involvement. Oral BDP has a limited systemic absorption into the blood stream, decreasing the potential for the development of adverse side-effects frequently seen with systemic steroid therapies, like prednisone. These side effects include bone demineralization and interference with normal growth, which are particularly concerning in children.
The upcoming pivotal Phase 3 study will be a double-blind, randomized, controlled, multi-national trial and will seek to enroll approximately 150 subjects 6-17 years of age with endoscopically proven mild to moderate Crohn's disease. The trial will compare the rates of improvement of the signs and symptoms of Crohn's disease after 8 weeks of treatment among subjects randomized to one of three SGX203 dose groups (split 60:30:60 among the lowest, middle and highest dose of SGX203). Subjects will be followed for an additional 6 months after the completion of treatment. Entry criteria for the trial are the presence of Crohn's disease symptoms (abdominal pain and/or diarrhea) associated with laboratory evidence of active disease in the blood. The primary clinical efficacy endpoint of the trial will compare the percentage of subjects in each of the three dose groups having resolved their signs and symptoms after an 8-week course of treatment. An adaptive design will be employed in which an independent Data Monitoring Committee will review the efficacy data after approximately 90 subjects have completed treatment and determine if the trial size requires adjustment based on the actual event rate or halted for futility or overwhelming efficacy. The trial is anticipated to begin in the second half of 2015 with primary data available in the first half of 2017.
"We are excited to move forward with this trial in an effort to improve the signs and symptoms of acute attacks of pediatric Crohn's disease while minimizing the deleterious side-effects often seen with systemic steroids," stated Richard Straube, MD, Chief Medical Officer of Soligenix. "Currently, most pediatric patients with mild to moderate active disease are treated with off-label prednisone. The side effects of prednisone, such as bone demineralization and interference in normal growth, are particularly concerning in children. We believe that SGX203 has the potential to deliver adequate doses of BDP to the GI tract with markedly reduced systemic toxicity. This, in turn, may offer physicians and patients an effective, and safer, therapy to control disease symptoms."
"We are pleased to have FDA agreement on this Phase 3 protocol after having worked closely with the FDA on its design," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are excited to move forward with this pivotal trial in an effort to address the significant unmet medical need that currently exists in this orphan disease."
Today, Biogen (NASDAQ: BIIB) announced detailed results from the Phase 2 RENEW study of anti-LINGO-1 in acute optic neuritis (AON) – the first clinical study to demonstrate remyelination (the formation of new myelin on axons) following an inflammatory injury in humans. These data will be presented at the 67th Annual Meeting of the American Academy of Neurology (AAN) in Washington, DC, next week.
The new data demonstrate a statistically significant improvement in recovery of optic nerve conduction latency (time for a signal to travel from the retina to the brain's visual cortex), as measured by the primary endpoint full-field visual evoked potential (FF-VEP), among anti-LINGO-1-treated participants at the last study visit (week 32), as compared to placebo. Results from a sub study of multifocal VEP (mfVEP) are consistent with the FF-VEP findings. These data supplement the top-line, 24-week RENEW results reported by Biogen in January 2015.
"RENEW is the first study to show repair of the human central nervous system (CNS) through remyelination, and the results support our ongoing development of this molecule," said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen. "We believe the anti-LINGO-1 data point toward a potential new approach to treating demyelinating diseases, and we look forward to the ongoing Phase 2 SYNERGY study results to further clarify the potential of this investigational therapy in MS."
Several physicians and practices have selected Allscripts (Nasdaq:MDRX) for IT solutions and analytics services that help them succeed with value-based care and reimbursement models, including the full formation of accountable care organizations (ACO) leveraging the company's Value-based Care Services from the Professional Physicians Business.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, and Lummy (Hong Kong) Co. Ltd., a wholly owned subsidiary of Chongqing Lummy Pharmaceutical Co. Ltd. (Stock code: 300006) ("Lummy HK"), today announced they have entered into a license agreement.
Athersys, Inc. (Nasdaq:ATHX) will release its first quarter 2015 financial results at approximately 4:00 PM EDT on Monday, May 11, 2015, and host a conference call shortly thereafter at 4:30 PM EDT to review the results.
BioCorRx, Inc. (BICX), developer of the Start Fresh Program, announces that the Company's pilot program that was created as a result of an agreement with Myriad Medical Marketing (MMM) is scheduled to launch later this month. As of April 27, 2015 Corona Physical Medicine (CPM) in Corona, CA plans to begin setting appointments with potential patients. CPM is located at 1150 El Camino Avenue, Suite 108, Corona, CA 92879.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, April 30, at 4:30 p.m. ET to discuss first quarter 2015 financial results and provide a general business update.
BioSig Technologies (OTCQB:BSGM), a medical device company developing PURE EP™ System, a proprietary technology platform designed to improve the clinical outcomes of electrophysiology procedures, today announced the opening of its second location and headquarters in Minneapolis, Minnesota.
Carbylan Therapeutics, Inc. (Nasdaq:CBYL) today announced the closing of its initial public offering of 14,950,000 shares of its common stock at an initial public offering price of $5.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,950,000 additional shares of common stock.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that Shin Oh, MD, one of its clinical investigators, will be making an oral presentation of safety and efficacy data from the Firdapse® Phase 3 clinical trial in patients with Lambert-Eaton myasthenic syndrome (LEMS) at the American Academy of Neurology (AAN) 67th Annual Meeting.
FEI Company (Nasdaq:FEIC) announced that it will release its financial results for the first quarter of 2015 after the financial markets close on Tuesday, April 28, 2015.
Forward Pharma A/S (Nasdaq:FWP) announced today that an interference was declared by the Patent Trial and Appeal Board (PTAB) on April 13, 2015 between the Company's patent application 11/576,871 (the "'871 patent application") and Biogen's issued patent 8,399,514 (the "'514 patent").
FutureWorld Corp. (OTC: FWDG), a leading provider of advanced technologies and solutions to the global cannabis industry, announced today that its Board of Directors has approved the "record date" and "dividend rate" of the stock of FutureLand Corp to its shareholders.
Healthcare Services Group, Inc. (Nasdaq:HCSG) reported that revenues for the three months ended March 31, 2015 increased approximately 14% to $355,246,000 compared to $312,165,000 for the same 2014 period. Net income for the three months ended March 31, 2015 was $15,516,000 or $0.22 per basic and per diluted common share, compared to the three months ended March 31, 2014 net income of $14,639,000 or $0.21 per basic and per diluted common share.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the home care setting, today announced that it is delaying the filing of its Annual Report on Form 10-K for the year ended December 31, 2014.
Inovalon (Nasdaq:INOV), a leading technology company providing advanced cloud-based data analytics and data-driven intervention platforms to the healthcare industry, announced that it has entered into a new multi-year agreement with two Consumer Operated and Oriented Plans (CO-OPs): Arches Health Plan of Utah and Montana Health CO-OP (plus Idaho as Mountain Health CO-OP) to provide solutions to improve clinical and quality outcomes and financial performance for their quickly approaching 100,000 commercial Affordable Care Act (ACA) member populations.
Mallinckrodt Pharmaceuticals (NYSE:MNK) has been named National Corporate Sponsor for the 2015 Kidney Walk and will sponsor 100 Kidney Walk events in major U.S. cities as part of its support of the National Kidney Foundation (NKF).
MRI Interventions, Inc. (OTCQB:MRIC) today announced that its ClearPoint® neuro navigation platform will be on exhibit at the 2015 Annual Meeting of the American Association of Neurological Surgeons (AANS) May 4-6, 2015, in Washington, D.C.
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced that the company has received clearance from the U.S. Food and Drug Administration (FDA) to market the MicroThermX® Microwave Ablation System (MicroThermX) for the specific indication of ablation procedures requiring partial or complete ablation of non-resectable liver tumors.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that Thomas Liquard has joined its Board of Directors and will become Chairman of the Audit Committee.
Praxsyn Corporation's (OTCQB:PXYN) wholly owned subsidiary, Mesa Pharmacy Inc. (Mesa), entered into a Business Associate Agreement with Products for Doctors for marketing and other services on January 23, 2015.
The Shareholders Foundation, Inc. announces that a lawsuit was filed on behalf of certain purchasers of shares of Castlight Health Inc (NYSE:CSLT) over alleged Violations of Securities Laws by Castlight Health in connection with certain allegedly false and misleading statements.
Stericycle, Inc. (Nasdaq:SRCL) will give a presentation on Tuesday, May 5th by Charlie Alutto, President and CEO, at 2:25 PM Central time at Baird's 2015 Growth Stock Conference at the Four Seasons Hotel in Chicago.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced two upcoming presentations related to its immuno-oncology portfolio.