Monday, May 21, 2012

FDA Updates: HEPI, CBRX, CTIC, MYRX

The following is a list of clinical FDA updates for: Health Enhancement (OTC:HEPI), Columbia Laboratories (NASDAQ:CBRX), Cell Therapeutics (NASDAQ:CTIC), Myriad Pharmaceuticals (NASDAQ:MYRX)

HEPI.ob: ProAlgazyme(PAZ), iquid extract from living algae grown in purified water, announced on 4/26/10,credit/fusing secured to complete current safety/toxicity study, file IND application and begin Phase 0 micro-dose study to determine potential pharmacological activity for recently identified compounds contain in PAZ with year end 2010 estimate to begin study. Updated 6/8/10.

CBRX: PROCHIEVE 8%, progesterone gel, to reduce the risk of pre-term birth in women with a short cervix at mid-pregnancy, agreement with WPI includes additional payments up to $45.5M on future milestones, expects to report top-line results by year end 2010 to support potential NDA filing by mid-2011, enrolment complete 6/8/10. Updated 6/8/10.

CTIC:OPAXIO(paclitaxel poliglumex), CT-2103 formerly XYOTAX, plans to meet with FDA during 2H10 to explore potnetila pivotal Phase 3 study design on Phase 2 results presented as ASCO on 6/7/10 demonstrating that 38% 15/40 patients received OPAXIO in combo with cisplatin/radiation achieved pathologic or endoscopic complete response. Updated 6/8/10.

MYRX: MDC-3100, synthetic heat shick protein 90 or Hsp90 inhibitor anti cancer agent, expects to report Phase 1 safety, tolerability and pharmacokinetic results during 2H10.

MYRX: AZXIA (MCP-6827), (verbulin) a small molecule microtubule destabalizing anti-cancer agent, announced on 6/8/10, plans to expand ongoing study to include a two armed TEMODAR (temozolomide) combo study for treatment of brain cancer (GBM) Clinicaltrials.gor ID NCT00892931 with estimated results during 1Q11, Updated 6/8/10.



[[T_F]]Data Leak Prevention – Data Security Solutions – Information Theft Protection, Detection and Prevention Software Productstracefusion_signature=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[[T_F]]

Initially starting in the film industry, during the past three years, Edoardo has studied the financial markets along with a few of his closest friends and began writing as an editor for one of the largest newspaper publications in his city. This offered him the opportunity to meet new co-workers and lifelong friends which ultimately led to him into moving onto helping form TheMarketFinancial.com. His portfolio style often follow the biotech field, with a mixture of long and short ideas, and has been quoted in a number of well known online financial publications. He prides in investigative research through the use of SEC filings, FDA calendars and mainstream media in order to bring about the most interesting stories to life.
Edoardo Lopezpineda
Edoardo Lopezpineda

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