Allos Therapeutics Inc. (NASDAQ: ALTH), a biopharmaceutical company engaged in the development and commercialization of small molecule drugs for the treatment of cancer, announced today the results from its ENRICH study failed to meet its primary endpoint.ENRICH is the company’s pivotal Phase 3 study of Efaproxyn combined with whole brain radiation therapy (WBRT) in women with brain metastases (cancer) originating from breast cancer. The study failed to reach its goal of demonstrating a significant improvement in overall survival in patients receiving the drugs in combination, as compared to those patients only receiving WBRT.
Women participating in the study were given either Efaproxyn and WBRT or WBRT alone. Though the women who took both drugs survived an average of 8.5 months as compared to 7.5 months in patients taking WBRT alone, the results were not considered statistically significant.
Allos shares rose $1.08, or 19 percent, to $6.69 this morning after the company addressed its shareholders, patients and staff with the announcement posted early this morning.
“I would like to acknowledge the patients and investigators for their participation in the ENRICH study,” said Paul L. Berns, president and CEO of Allos, in the press release. “We continue to move forward with focus and determination … and look forward to providing future updates on our clinical progress.”
The company said it intends to turn its focus from Efaproxyn to advancing the development of PDX, its novel antifolate evaluation, in patients with relapsed or refractory peripheral T-cell lymphoma.
“Although we are disappointed with the results of the ENRICH study, we are excited about the potential of our product pipeline,” said Dr. Pablo J. Cagnoni, Allos’ chief medical officer. “We expect to provide the next update on our PDX PROPEL study later this year following completion of a pre-specified interim analysis of response data after 35 patients have completed at least one cycle of treatment with PDX.”
Shares of Allos were down slightly from this morning, trading at 10 cents just before noon CDT.
