Repros Reported Interim Results From The Impact of Androxal; Alnylam Added Orphan Drug Status for ALN-AT3 Print E-mail
By Staff and Wire Reports   
Tuesday, 20 August 2013 19:49

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 20, 2013. Repros Therapeutics's (NASDAQ:RPRX), Study ZA-303 is a single blind placebo controlled study with an Androxal to placebo ratio of 2:1. Men assigned to Androxal were required to exhibit morning testosterone levels of <300 ng/dL on two consecutive mornings. Men assigned to placebo had to meet all the criteria of age (<60) and BMI (>25) of those men assigned to Androxal with the exception that their testosterone level could be in the normal range.

At the 6 month time point, there is no evidence that Androxal reduces bone mineral density as assessed by DEXA scans. In addition, there is some evidence that Androxal may be beneficial to bone health. Overall, there is a consistent trend in many bone regions where an improvement of bone mineral density in comparison to placebo is observed. Subjects treated with 25 mg of Androxal exhibited a statistically significant increase in total hip bone mineral density compared to placebo (p = 0.0339). However, although one should be encouraged by these positive findings, clinically significant changes in bone mineral density generally require exposures longer than 6 months and early results do not always predict final results.

Study ZA-303 also indicates that testosterone may be more influential in maintaining bone health than previously expected. Repros was surprised to find that a relatively high percentage of subjects, 12%, screen failed due to low bone mineral density in this relatively young population (mean age 48).

Topline results from the first 150 subjects completing 12 months of exposure are expected in the second quarter of 2014. Based on the progress in this study and others, the NDA remains on track for submission in mid-2014.

The Company has requested guidance from the FDA regarding what additional work would be required to incorporate these positive findings on bone mineral density into the Androxal label under a separate IND.


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Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced the U.S. FDA has granted an Orphan Drug Designation (ODD) to ALN-AT3 as a therapeutic for the treatment of hemophilia A. As reported last week, the FDA has also granted ODD to ALN-AT3 for the treatment of hemophilia B. Alnylam is developing ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin (AT), for the treatment of hemophilia – including hemophilia A, hemophilia B, and hemophilia A or B with “inhibitors” – and other Rare Bleeding Disorders (RBD).

“We are very pleased that the FDA has granted Orphan Drug Designation for ALN-AT3 now for both the treatment of hemophilia A and hemophilia B. As a subcutaneously delivered RNAi therapeutic, we believe it represents an innovative approach for the management of hemophilia and has great potential to make a meaningful impact in the treatment of this often debilitating bleeding disorder,” said Saraswathy (Sara) Nochur, Ph.D., Senior Vice President, Regulatory Affairs and Quality Assurance at Alnylam. “ALN-AT3 is a key program in our ‘Alnylam 5x15' product development and commercialization strategy, and we look forward to advancing this promising RNAi therapeutic into the clinic in the months to come.”

At the recent Congress of the International Society on Thrombosis and Haemostasis, Alnylam presented pre-clinical data demonstrating that ALN-AT3 can normalize thrombin generation and improve hemostasis in hemophilia mice and can fully correct thrombin generation in a non-human primate (NHP) hemophilia “inhibitor” model. ALN-AT3 utilizes the company's proprietary GalNAc conjugate delivery platform, enabling subcutaneous dose administration. Alnylam plans to file an investigational new drug (IND) application for ALN-AT3 in the fourth quarter of 2013 and initiate a Phase I clinical trial in early 2014.

The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. OOPD provides incentives for sponsors to develop products for rare diseases. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.


Also Tuesday:

 

Arrhythmia Research Technology, Inc. (NYSE MKT: HRT) reported today that it was unable to file its quarterly report on Form 10-Q for the three months ended June 30, 2013 within the automatic extension of its due date to August 19, 2013 afforded by its filing of a Form 12b-25 Notification of Late Filing with the Securities and Exchange Commission.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, the Breast Health Company™, today announced the publication of a peer-reviewed paper titled "A phase I safety and efficacy study of the mammary aspirate specimen cytology test device for collection of specimens for exfoliative cytopathology of the breast ducts."

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that a BIOLASE® informational news segment on WaterLase® dentistry aired on CNBC on Saturday, August 17 at 5:30 PM Eastern Time/2:30 PM Pacific Time, and will be aired on upcoming broadcasts of the Fox Business Network and Bloomberg International Network in the next several months.

Fresh Start Private Management, Inc. (OTCQB: CEYY)
, a leader in alcohol treatment and rehabilitation programs, announced that the company has entered into two definitive licensing and distribution agreements with Fresh Start Private Midwest, LLC and Fresh Start NoCal, LLC.

GeoPetro Resources Company (OTCQB:GEOR) (NYSE MKT:GPR)
announced today that its common stock will begin trading on the OTCQB Marketplace tomorrow, August 21, 2013, under the new trading symbol "GEOR".

HPIL Holding (OTCQB: HPIL)
is pleased to announce that the Company's Form 10-Q for the fiscal quarter ended June 30, 2013, has been filed and is available for review on the SEC EDGAR site.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that Richard L. Sherman, J.D., has been appointed to the Company's Board of Directors.

MiMedx Group, Inc. (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its study "Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amniotic/Chorionic Membrane Allograft for Plantar Fasciitis—A Feasibility Study"has been electronically published in the journal, Foot & Ankle International.

Nuvilex, Inc. (OTCQB: NVLX)
just acquired oncology assets that make this small Silver Spring, Maryland, biotech worth more today than it was just a month ago.

QualityStocks today announced that a new audio interview with OxySure Systems, Inc. (OTCQB: OXYS) is now available.

Urologix®, Inc. (OTCQB:ULGX)
, the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today reported financial results for its fiscal year fourth quarter and fiscal year ended June 30, 2013.




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