|Repros' Proellex Receives FDA Guidance; BioLineRx Receives Regulatory Finnish Approval for BL-7010|
|By Staff and Wire Reports|
|Monday, 04 November 2013 19:35|
Repros Therapeutics Inc.® (Nasdaq: RPRX) reported it has received guidance from the FDA regarding its clinical program for low dose oral Proellex in the treatment of uterine fibroids.
The Company currently has three open INDs for Proellex: 70,535 - oral treatment of fibroids STATUS: Full Clinical Hold; 76,631 – oral treatment for endometriosis STATUS: Partial Clinical Hold and in Phase 2; 112,576 – vaginal treatment for fibroids STATUS: Initiating Phase 2b
The Company held a meeting with the FDA on October 31, 2013 to discuss "going forward" plans for low dose oral Proellex in the treatment of uterine fibroids and to lift the clinical hold. In 2007, data had been discussed with the FDA based on the efficacy of a 12mg dose. The earlier study showed highly statistically significant results in achieving clinically relevant improvements in menstrual bleeding as well as symptoms associated with tumor bulk via a previously validated quality of life instrument (UFSQOL).
During the meeting with the FDA, the Agency provided guidance to the Company for endpoints it believed to be acceptable for the treatment of uterine fibroids. The Agency instructed the Company to submit a request for lifting of the full clinical hold at the same time it submits a new protocol. The Company will follow FDA's recommendations and submit the protocol and full hold lift in a timely fashion.
The Company will use the same design for the vaginal Phase 2b study and expects to start the two studies in early 2014. The Company has accounted for the costs of these studies in its current budget and these studies will not change the projected cash burn rate for 2014.
BioLineRx (NASDAQ: BLRX) announced it has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health (Valvira) to commence a Phase 1/2 safety trial for BL-7010, for the treatment of celiac disease. The study is expected to begin by the end of this year.
The Phase 1/2 study is a two-part (single and repeated), double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients at a world-leading site for celiac disease research in Finland. The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients. Secondary objectives include an assessment of the systematic exposure, if any, of BL-7010 in the study patients.
Professor Markku Maki, M.D., Ph.D., of the University of Tampere School of Medicine and the Tampere Center for Child Health Research in Finland, the responsible coordinating investigator of the trial, stated, "Celiac has become an increasingly problematic condition, with 1% of the world's current population suffering from this disease.
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces the initiation of a clinical development program with masitinib in the treatment of Amyotrophic Lateral Sclerosis (ALS).
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AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today that Joseph M. DeVivo, President and Chief Executive Officer, will present at the following investor conferences in late November.
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Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announced that its Chief Executive Officer, Jeffrey A. Duchemin, has been appointed by the Board of Directors to the additional positions of President and Director, effective immediately.
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Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it intends to offer, subject to market conditions and other factors, 3,500,000 shares of its common stock in an underwritten public offering registered under the Securities Act of 1933, as amended. In connection with the offering, Integra expects to grant the underwriters a 30-day option to purchase an additional 525,000 shares of common stock.
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Luminex Corporation (NASDAQ: LMNX) today announced financial and operating results for the third quarter ended September 30, 2013.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization, announced today that PCT has entered into a collaboration with ATMI, Inc. (Nasdaq:ATMI), a global technology company and leader in single-use bioprocess solutions.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that it will host a meeting for investors and analysts at its NuVasive East office, 117 West Century Road, Paramus, NJ, 07652, on Thursday, November 14, 2013 from 8:30 a.m. to 11:00 a.m. ET.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, will announce financial results for the third quarter ended September 30, 2013, on Tuesday, November 12, 2013 prior to market open.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that Peter Langecker, M.D., PhD., President and Chief Executive Officer, will provide a corporate overview at the 19th annual BIO-Europe international partnering conference on November 6, 2013 at 9:45 GMT at the Messe Wien Exhibition and Congress Center, Vienna, Austria.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will report third quarter 2013 results on Tuesday November 12, 2013.
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that its PLacental eXpanded (PLX) cells proved to be safe in an animal study assessing maternal and fetal toxicity.
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SIGA Technologies, Inc. (Nasdaq:SIGA) announced today that management will host a conference call and simultaneous webcast to provide a quarterly business update at 5:00 P.M. ET on Wednesday, November 6, 2013.
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