Aeterna Zentaris: Final Data for Phase 1 Portion of Ongoing Phase 1/2 Trial with Zoptarelin Doxorubicin in Prostate Cancer Published in Clinical Cancer Research
QUÉBEC CITY, Dec. 29, 2014 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") today announced that an article on final data for the Phase 1 portion of the ongoing Phase 1/2 trial in prostate cancer with zoptarelin doxorubicin (formerly AEZS-108), a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin, has been published in the December issue of Clinical Cancer Research. The article outlines data previously disclosed in June 2013 at the American Society of Clinical Oncology's ("ASCO") Annual Meeting, which demonstrated the compound's safety profile and promising anti-tumor activity in heavily pre‑treated men with castration- and taxane-resistant prostate cancer. These results led to the current investigator-driven Phase 2 portion in this same indication under the supervision of lead investigator, Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center. Titled, "Phase I, Dose-Escalation Study of the Targeted Cytotoxic LHRH Analog AEZS-108 in Patients with Castration- and Taxane-Resistant Prostate Cancer", Liu SV, Tsao-Wei DD, Xiong S, Groshen S, Dorff TB, Quinn DI, Tai YC, Engel J, Hawes D, Schally AV, Pinski J., the article is available at this link: Clin Cancer Res.
David Dodd, Chairman and CEO of Aeterna Zentaris stated, "The Phase 1 portion data are very encouraging and we look forward to further results from the current Phase 2 portion of this investigator‑driven trial. Because luteinizing hormone-releasing hormone receptors are expressed in a great number of prostate cancers, we believe that zoptarelin doxorubicin, which specifically targets those receptors, may represent a novel targeted treatment for men with this disease. Expansion into prostate cancer with zoptarelin doxorubicin after positive Phase 2 results in endometrial and ovarian cancer, is further demonstration of the potential of this innovative compound in a variety of cancer indications which affect men as well as women, and could provide the Company with a significant market opportunity."
Phase 1 Results and Conclusions
Luteinizing hormone-releasing hormone ("LHRH") receptors are expressed on the cell membrane of many tumors, including prostate cancer ("PC"). This Phase I study with zoptarelin doxorubicin which targets these LHRH receptors, determined the maximum tolerated dose ("MTD") of this agent in men with taxane- and castration-resistant PC while providing additional information on its safety profile and efficacy. Zoptarelin doxorubicin was administered as an intravenous infusion every 21 days until progression or unacceptable toxicity in cohorts of 3 or 6 patients until the maximum tolerated dose ("MTD") was reached. The MTD of zoptarelin doxorubicin in this cohort was 210 mg/m2, which was lower than that seen in a Phase I study conducted in women with endometrial or ovarian cancers. The dose limiting toxicity was persistent neutropenia. Three patients had a prostate-specific antigen ("PSA") response with an additional 10 patients maintaining PSA stable disease. Of the 10 patients evaluable by RECIST criteria, 9 achieved stable disease. These findings show that zoptarelin doxorubicin has an acceptable safety profile and a signal of efficacy, lowering PSA in heavily pretreated patients with prostate cancer, and that internalization of zoptarelin doxorubicin in PC circulating tumor cells may be a viable pharmacodynamic marker.
Current Phase 2 Portion of the Study
This is a single-arm Simon Optimum design Phase 2 study of zoptarelin doxorubicin involving up to 37 patients with pre‑treated castration-and taxane-resistant prostate cancer, using the dose selected (210 mg/m2) in the Phase 1 portion. The primary endpoint is to evaluate the clinical benefit of zoptarelin doxorubicin for these patients. Clinical benefit will be defined as non-progression at 12 weeks with no dose‑limiting toxicity or other toxicity requiring termination of treatment.
More information on the current Phase 2 portion of the trial is available at this link: NCT01240629.
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. In addition to the ongoing investigator-driven Phase 2 trial in prostate cancer, the Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer. Aeterna Zentaris owns the worldwide rights (ex. China, Hong Kong and Macau) to this compound.
About Prostate Cancer
Prostate cancer is the most frequently diagnosed cancer in men aside from skin cancer. An estimated 233,000 new cases of prostate cancer will occur in the U.S. during 2014. With an estimated 29,480 deaths in 2014, prostate cancer is the second-leading cause of cancer death in men.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
SOURCE Aeterna Zentaris Inc.
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