CORAL SPRINGS, Florida, July 9, 2015 /PRNewswire/ --
Researchers & Biotech companies are constantly searching for tailor-made treatment plans for bone marrow conditions such as aplastic anemia as part of an emerging precision medicine movement which likely will help doctors optimize treatment for this rare and deadly blood condition. Even with the Biotechnology struggling a bit this week in markets, companies in focus today with news and current developments are Regen BioPharma, Inc. (OTCBB: RGBP), Oculus Innovative Sciences, Inc. (NASDAQ: OCLS), Horizon Pharma plc (NASDAQ: HZNP), AstraZeneca Pharmaceuticals Co. (NYSE: AZN) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
Regen BioPharma, Inc. (OTC: RGBP) reported today the successful dosing of mice lacking an immune system in a safety and tolerability study with HemaXellerate, the Company's proprietary aplastic anemia cell therapy drug candidate. The experiment is being conducted under Good Laboratory Practices (cGLP) by Charles River Laboratories. Charles River Laboratories, established in 1947, is well respected NYSE-traded contract research organization with 8,500 employees specializing in a variety of pre-clinical and clinical laboratory services for the pharmaceutical, medical device and biotechnology industries. The purpose of the study is to evaluate whether administration of more than ten-fold the proposed clinical dose of cells in mice on a per weight basis will cause any adverse effects on the experimental mice. The study was conducted in response to the last material question posed by the US Food and Drug Administration ("FDA") to Regen with regard to Regen's proposed clinical trial evaluating HemaXellerate in patients with aplastic anemia.
Read the full RGBP Press Release at http://www.financialnewsmedia.com/profiles/rgbp.html
"Given that HemaXellerate is generated from the patient's own fat (adipose) tissue, we are highly optimistic that no adverse effects will be observed." Stated Thomas Ichim, PhD, Chief Scientific Officer of Regen BioPharma. "It was important to conduct this study in mice lacking an immune system because we will be administering human cells. The immune deficient mice provide an excellent and trusted model of evaluating human cell therapies in the rodent system." Safety parameters evaluated will include: weight changes, alteration in cellular structures of the major organs, organ function, serum biochemistry, and hematology tests. The initial observation will take 14 days, after which data will be collected, analyzed, and submitted to the FDA. Charles River Laboratories anticipates submission to Regen BioPharma, Inc. of an audited draft report by September 16, 2015.
In other biopharmaceutical news & developments: Oculus Innovative Sciences, Inc. (NASDAQ: OCLS), a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, announced the receipt of a new U.S. patent for the use of the Microcyn(R) Technology hypochlorous acid in the treatment and mitigation of atopic dermatitis. Dr. Bob Northey, Oculus senior vice president for research and development said: "Our intellectual property portfolio is perfectly synced with our new focus on the dermatology market with our direct sales force. The empirical evidence demonstrating Microcyn's efficacy in the treatment of atopic dermatitis is highly compelling. This new patent provides Oculus market exclusivity for the use of hypochlorous acid with broad ranges of activity in the treatment of atopic dermatitis until the year 2027 when the patent expires."
Depomed, Inc. (DEPO) confirmed this week that it has received an unsolicited, highly conditional, non-binding proposal from Horizon Pharma plc (NASDAQ: HZNP) to acquire all of the outstanding shares of Depomed in an all-stock transaction valued at $29.25 per share. Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs.
AstraZeneca Pharmaceuticals Co. (NYSE: AZN) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that top-line data demonstrate linaclotide met all primary and secondary endpoints, covering multiple abdominal and constipation symptoms, in a Phase III clinical trial of adults with irritable bowel syndrome with constipation (IBS-C). The trial was conducted primarily in China and the companies intend to file in early 2016 for China Food and Drug Administration (CFDA) approval to market linaclotide. Linaclotide is currently approved in the United States for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC) and in a number of other countries for adults with IBS-C.
Raptor Pharmaceutical Corp (NASDAQ: RPTP) Climbs On Strong Volume on Wednesday - Despite Oppenheimer downgrading the stock recently - Read more at http://cnafinance.com/raptor-pharmaceutical-corp-rptp-climbs-on-strong-volume/4365 - Raptor Pharmaceutical Corp. is a global biopharmaceutical company focused on the development and commercialization of life-altering therapeutics that treat rare, debilitating and often fatal diseases.
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