|Aeterna Zentaris Issues Encouraging Updated Data on LHRH Receptor; Peregrine Highlights Bavituximab's Tumor Therapy at Annual Meeting|
|By Staff and Wire Reports|
|Wednesday, 10 April 2013 19:09|
Aeterna Zentaris Inc. (NASDAQ: AEZS) presented encouraging updated proof-of-concept results for Disorazol Z cytotoxic conjugates, such as AEZS-125 and AEZS-138, in human ovarian and endometrial cancer xenograft models. Results further showed the compounds' high potential for the treatment of luteinizing hormone-releasing hormone ("LHRH") receptor positive tumors. Data were presented earlier today by Babette Aicher, PhD, the Company's Director of Preclinical Development, during a poster presentation at the American Association for Cancer Research ("AACR") annual meeting currently being held in Washington D.C. The study is funded through a grant from the German Ministry of Education and Research.
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "Disorazol Z cytotoxic conjugates such as AEZS-125 and AEZS-138 are an extension of our AEZS-108 innovative LHRH-targeted platform in oncology. These results confirm the encouraging data presented at the ENA Symposium in November 2012, and will enable us to better select a specific drug candidate for further preclinical development expected to start during this quarter."
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, highlighted data presented at the Annual Meeting of the American Association for Cancer Research (AACR). Data was presented this week from preclinical studies investigating the immune-stimulating mechanism of action of Peregrine's lead phosphatidylserine (PS)-targeting oncology clinical candidate bavituximab and the anti-tumor and imaging potential of other PS-targeting molecules.
Bavituximab is currently being evaluated in several oncology clinical trials including the lead indication of second-line non-small cell lung cancer (NSCLC), which is anticipated to advance into a pivotal Phase III trial later this year. "These studies yield important insights into the fundamental role that exposed PS plays in tumor immune evasion, and further support our lead clinical candidate bavituximab's ability to reactivate tumor immunity. This is now clearly evidenced by several specific measurements of both the immune-stimulating and anti-tumor mechanisms mediated by PS-targeting antibodies as well as imaging studies demonstrating that tumor growth inhibition is correlated with PS expression levels in tumors," said Jeff T. Hutchins, Ph.D., vice president of preclinical research at Peregrine Pharmaceuticals. "Included in these presentations was a compelling finding of a pronounced antibody-mediated increase in tumor-fighting immune cells that is independently correlated with an impressive survival benefit in patients with NSCLC based on a published retrospective study of clinical data(1) . When taken together, these results support PS as a promising oncology drug target and provide additional rationale for the impressive Phase II survival data we have seen in bavituximab's lead indication of second-line NSCLC."
Data presented from imaging studies(2) demonstrate that the chemotherapeutic drug docetaxel, a commonly prescribed second-line treatment for patients with advanced NSCLC, increases the exposure of bavituximab's target molecule, phosphatidylserine (PS), on tumor blood vessel cells and tumor cells. Results also showed that PS exposure in tumors is correlated with tumor burden and response to docetaxel treatment, supporting exposed PS as a promising biomarker of cancer and response to therapy. Peregrine's PS-targeting imaging agent I-124-PGN650 is currently being evaluated in a clinical trial to assess its safety and potential to image multiple tumor types in patients with cancer. Additional data presented from a series of preclinical studies(3) demonstrate that PS-targeting antibodies mediate immuno-stimulatory changes in tumors resulting in an increase of tumor-fighting (M1) macrophages, immune cells strongly associated with survival benefits in patients with NSCLC(1) . Peregrine recently reported promising data from a randomized, double-blind, placebo-controlled Phase II second-line NSCLC clinical trial demonstrating a 60% improvement in median overall survival (OS) in patients receiving 3 mg/kg bavituximab plus docetaxel compared to the control arm.
The company plans to meet with the U.S. Food and Drug Administration (FDA) in the second quarter of calendar year 2013 with the goal of initiating a Phase III trial by calendar year-end. Researchers also presented details of new PS-binding constructs(4).
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Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today presented encouraging updated proof-of-concept results for Disorazol Z cytotoxic conjugates, such as AEZS-125 and AEZS-138, in human ovarian and endometrial cancer xenograft models.
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