FDA, Clinical Trial Updates: NASDAQ:GTXI, NASDAQ:XNPT, NYSE:GSK, NASDAQ:RMTI

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

GTx Inc. (NASDAQ:GTXI): Over the weekend, GTXI presented additional Phase 3 data analyzing placebo group data from a study of advanced prostate cancer patients being treated with androgen deprivation therapy (ADT) that revealed nearly one in four placebo group subjects developed bone fractures or critical bone loss (>7% loss) within two years. During the two year trial, 9.9% of these men had a non-traumatic fracture while 23.9% experienced either a non-traumatic fracture or bone loss of more than 7%.

GTXI is awaiting a FDA decision (expected in October) for its toremifene 80 mg NDA to prevent bone loss associated with prostate cancer. Toremifene 80 mg is an oral selective estrogen receptor modulator which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT is the primary treatment for advanced prostate cancer and about 700,000 men in the U.S. with prostate cancer are being treated with this therapy).

XenoPort (NASDAQ:XNPT) and GlaxoSmithKline (NYSE:GSK): Shares of XNPT lost about 20% on Monday after reporting Phase 2 clinical trial results for gabapentin enacarbil (GSK1838262/XP13512) as a treatment for nerve pain associated with diabetic peripheral neuropathy in adults. The compound failed to achieve its primary endpoint versus placebo based on a pain intensity rating scale in the 14-week study; although the drug was well tolerated with no serious side effects. XNPT and GSK are awaiting a FDA decision during 4Q09 to market the compound as Solzira in the treatment of moderate to severe restless leg syndrome (RLS).

Rockwell Medical (NASDAQ:RMTI): In mid-April, RMTI announced that the independent Data Safety Monitoring Board (DSMB) providing oversight for the ongoing SFP Phase 2b dose-range study reviewed the interim study data and informed the Company of the following: (1) no safety concerns were identified, (2) there is no need to add the highest SFP dose group of 20 ug/dl, and (3) continuation of the study was recommended with the five existing dose groups. The following is an outline of expected clinical and development milestones for Rockwell's lead iron replacement therapy compound SFP.

+ complete enrollment in ongoing SFP Phase 2b study during 2Q09

+ complete SFP Phase 2b trial by end of 3Q09 with data released in about 60 days (before year-end)

+ begin pivotal (to file for FDA approval) Phase 3 trial for SFP during 4Q09-1Q10

            - adequate liquidity and cash flow to reach the start of Phase 3 trials

            - possible licensing deal to fund completion of Phase 3 trials

+ expected FDA approval and market launch of SFP in 2011

            - capturing just 10% share of the $500M IV iron market in U.S. would double current revenue

            - expects $80M in annual revenue from core business by the time of SFP launch

            - little incremental expenses since SFP would be sold and distributed to same customers

+ clinical trial results expected 1Q10 in a 30-patient NIH, non-FDA study

Below is a link to a 10-page PDF report, which is freely available to view or download in stock research section of BioMedReports.com at http://biomedreports.com/research/cat_view/41-stock-research-reports.html

The report is also available on the RMTI page of a new website I have launched at StockMediaBuzz.com to track my coverage universe of stocks: http://www.stockmediabuzz.com/RMTI.html

Disclosure: No positions.

BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section

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