Oxigene Nears Cancer FDA Catalysts

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spacerBreaking News and Insider ScoopsNovember 29, 2010
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Oxigene Nears Marketing Approval Of First Ever Anaplastic Thyroid Cancer Drug
(NASDAQ:OXGN)

With just a few weeks left on the calendar before the world’s largest oncology annual meeting, investors are already gearing up their portfolios for equities that could see exponential gains based on their potentially new research abstracts. The American Society of Clinical Oncology (ASCO) will begin on May 18th and will feature everything from investigational new drugs to well developed late-stage products. While many companies have seen strong share appreciation leading up to their presentations, the real key lies in finding companies like Oxigene (NASDAQ:OXGN) which has yet to experience this momentum and mass media coverage.

At a market cap of only 10M, Oxigene remains the cheapest and most undervalued of all phase 3 late-stage oncology companies worldwide, with its flagship product, ZYBRESTAT targeting Tanaplastic Thyroid Cancer. The company has stated that they will be presenting the final phase 2/3 (FACT study) data for the drug at the ASCO, and many experts seem to be leaning towards highly positive results based on its previous clinical trials. Currently there exists no treatments available for this form of cancer other than radiation therapy and surgery which is usually combined with chemotherapy.

Just a few months ago, the company reported positive data from the FACT study of ZYBRESTAT plus chemotherapy in patients with Anaplastic thyroid cancer (ATC). At the 14th International Thyroid Congress, the company’s investigators reported that patients receiving ZYBRESTAT had a median overall survival (OS) time of 5.1 months, compared with a median survival time of 4.1 months for patients receiving chemotherapy alone. Furthermore, 48% of patients treated with ZYBRESTAT and chemotherapy were alive at six months, compared with 37% percent of patients treated with only chemotherapy and at one year, 23% of patients treated with ZYBRESTAT and chemotherapy were alive compared to 9% of patients treated with chemotherapy alone. These are some of the best results of any late-stage Aanaplastic thyroid cancer drugs seen worldwide, and this improvement in OS is meaningful, both clinically and on a personal level for patients. With no currently approved drugs in the market for treatment, the doors are wide open for Oxigene to step in and dominate it. The company also reported on March 21st that they had spoken with the FDA and received very positive type C meeting minutes stating that the trial data was highly suggestive of regulatory approval given an additional clinical trial with a suvival endpoint.

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  • $OXGN to present phase 3 data @ ASCO conference
  • $AEZS and $AVNR potential partnerships coming up
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