OXiGENE's Chief Executive Officer: "During the third quarter, we focused on pursuing our lead development programs and ensuring that we have the resources and capabilities we need to advance our ongoing clinical and regulatory strategies, and made progress in our earlier-stage programs. We have continued to focus on identifying a registration pathway in the US for ZYBRESTAT in ovarian cancer and, at the same time, pursuing registration for ZYBRESTAT in the EU for anaplastic thyroid cancer (ATC), utilizing the exceptional circumstances pathway for obtaining a European marketing authorization (MAA).
I believe Dai has been working on this with EMA for the past 2+ years.
When approved, it opens the door to treating some 800 ATC patients/yr.
800 X $50,000. = $40M annual ATC sales
The real potential in this, it opens the opportunity to use Zybrestat off-label in ovarian cancer with Avastin
in 300,000 plus relapsed patients in the EU .
Bottom line: It's safe, no real downside and it's better treatment than chemo.. and in ATC they have +20% OS.
I firmly believe that this is the catalyst.
Jun 10, 2013
"ATC affects 800 to 1,000 patients each year in the U.S. and a similar number in the European Union with a reported median survival around 3-4 months, with fewer than 10 percent of patients surviving one year," said Julie A. Sosa, M.D., Duke University School of Medicine, Durham NC, who was the Principal Clinical Investigator of the study. "This final publication of the FACT study data, suggests there might be clinically meaningful increases in both overall survival and one-year survival with ZYBRESTAT. It may represent a potential new therapeutic option for patients with ATC, who to this day have limited treatment options and generally dismal outcomes."
The preliminary results of the FACT study were previously presented as an oral presentation at American Society of Clinical Oncology (ASCO) meeting and named "Best of ASCO" in 2011.
That is the problem. Management should have already filed for ATC with the EU. They are slow walking the drug rather than seeking the fastest means to getting this drug approved. I guarantee that if a large pharma owned Oxigene or even was partnered on Zybrestat we would already have or be very close to EU approval for ATC and would be considered one of the leading combo drugs for ovarian. Instead, we crawl along and the market gives Oxigene's pipeline a value of less than $10 million instead of the billion dollar valuation it deserves.
My understanding is they can not file in the EU until they have shown stability in 3 commercial lots, and stability of one year. The big thing to me is they have walked back guidance on filing, they now say they are discussing the path to file. IMO, they should have PRed that they would file well before the last raise and I must say I am beginning to question whether they have released all the material information they needed to release before the last 2 raises.
and a nearly 200% increase in one-year survival. In early 2012, the CEO was saying that there are some patients who have been in treatment for over two years. I presume that if the patients would have progressed or had an adverse event, the treatment would have been discontinued. I was very optimistic....
It has been almost a year and what have they done to progress on any of this.....nothing, all they have done is dilute you long share holders. OXGN is going to make shorts rich, just like every other loser biotech out there.