Trial results take breath out of Oxigene Print E-mail
By Staff and Wire Reports   
Friday, 04 November 2011 05:16
biotech investingShares of Oxigene Inc.(OXGN) closed +6.40% higher on Thursday, but quickly headed lower after a post-market hours announcement that the final results from the FALCON phase 2 trial of ZYBRESTAT™ in non-small cell lung cancer patients were mixed.

The company tried to emphasize the positive in their news release, but results did not seem to indicate any overall survival (OS) benefit for the overall patient population, with the median OS at 13.6 months in the ZYBRESTAT™ arm versus 16.2 months in the standard therapy arm.

Given that, speculators are likely to dump out of the stock and send shares much lower. By the time after-hours trading was over, prices had dropped to $ 1.25 -.58 (-31.69%).

The final analysis of the data showed that the combination regimen of ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel (ZYBRESTAT arm) was observed to be well-tolerated with no significant cumulative toxicities or overlapping toxicities with bevacizumab when compared with the control arm of the study (standard chemotherapy plus bevacizumab). In addition, an analysis of patients with tumor burden greater than 10 cm suggested meaningful improvements in overall survival for patients receiving ZYBRESTAT in addition to bevacizumab and chemotherapy. For patients with this large tumor burden, median overall survival was 14.2 months, compared with 11.0 months for patients on the control arm of the study. For the overall patient population, no survival benefit was observed for patients receiving ZYBRESTAT.

"This final data reinforces our earlier observations that ZYBRESTAT in combination with bevacizumab and chemotherapy may have therapeutic utility for patients with large or hard-to-treat tumors and who appear not to be as well served by the standard therapy of carboplatin, paclitaxel and bevacizumab. The data also suggest that that two vascular targeting agents, ZYBRESTAT and bevacizumab, can be administered in combination with a manageable side effect profile. These results are suggestive and present an opportunity for further clinical exploration in the future," said Peter Langecker, M.D., Chief Executive Officer at OXiGENE. "OXiGENE's major focus remains on working towards a global registrational study of ZYBRESTAT in anaplastic thyroid cancer, including obtaining the necessary financing for such a study, as well as supporting our ongoing clinical program in ovarian cancer and earlier stage programs. We are extremely grateful to the patients and physicians who participated in the FALCON study."

Yesterday’s results certainly do not point in the direction of widely spread rumors that OXGN was on the verge of landing a partnership or a buyout from Big Pharma. We reported last week that social media searches for information and investor forum discussions about OxiGene (Nasdaq: OXGN) were trending higher. Recently, shares of the company had climbed from under $1 to yesterday's close at $1.83.

The company only has 24M  shares outstanding with 38.69% owned by Insiders and 1.90% owned by Institutions.

Key data points from the FALCON trial are as follows.

Overall Survival (OS)

  • OS determined by patients' survival status at last follow up.
  • Median OS was 13.6 months in the ZYBRESTAT arm versus 16.2 months in the standard therapy arm (HR with 95% CI: 1.06 (0.55, 2.03)).
  • Median OS in patients with aggregate tumor burden greater than 10 cm was 14.2 months in the ZYBRESTAT arm versus 11.0 months in the standard therapy arm (HR with 95% CI: 0.67 (0.26, 1.70)).
  • Median OS in patients with aggregate tumor burden of 10 cm or less was 13.6 months in the ZYBRESTAT arm versus 16.7 months in the standard therapy arm (HR with 95% CI: 1.38 (0.51, 3.74)).

Tolerability

  • The addition of ZYBRESTAT to standard therapy appeared to be well tolerated.
  • No significant overlapping toxicities with bevacizumab were observed.
  • Hypertension was increased in patients in the ZYBRESTAT arm of the study but was transient and manageable without significant cardiac toxicity.
  • Myelosuppression was increased in patients in the ZYBRESTAT arm of the study but did not result in significant dose reductions, sepsis or discontinuation of treatment.

Progression Free Survival (PFS):

  • PFS determined by RECIST criteria.
  • Median PFS was 8.6 months in the ZYBRESTAT arm versus 9.3 months in the standard therapy arm (HR with 95% CI: 1.04 (0.57, 1.91)).
  • Median PFS in patients with ECOG 0 status was 7.0 months in the ZYBRESTAT arm versus 11.6 months in the standard therapy arm (HR with 95% CI: 2.12 (0.93, 4.83)).
  • Median PFS in patients with ECOG 1 status was 9.8 months in the ZYBRESTAT arm versus 3.8 months in the standard therapy arm (HR with 95% CI: 0.51 (0.23, 1.16)).

As previously reported, best tumor response in terms of partial response (PR) was 56% in the ZYBRESTAT arm and 36% in the standard therapy arm.




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