Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”) today reconfirmed its commitment to LHRH-receptor targeted therapy and its expectation that the pivotal, phase 3 trial for Zoptrex™ (zoptarelin doxorubicin) in women with advanced, recurrent endometrial cancer, is expected to be completed in the third quarter of 2016. During the 2016 Annual Meeting of the American Society of Clinical Oncologists (“ASCO”), the Company also discussed its plans to develop Zoptrex™ for additional indications, based upon achieving a positive outcome in the current clinical program.
Zoptrex™ (zoptarelin doxorubicin), a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE), is the Company’s lead oncology compound. Zoptrex™ is currently in a fully-enrolled Phase 3 clinical trial in endometrial cancer. The Company expects to complete the Phase 3 clinical trial in the third quarter of 2016 and, if the results of the trial warrant doing so, to file a new drug application for Zoptrex™ in the first half of 2017.
Commenting on the significance of Zoptrex™ to oncologists and their patients, Dr. Richard Sachse, the Company’s Chief Scientific Officer, explained, “Zoptrex™ is the first targeted oncological therapy using a peptide as the targeting agent and, therefore, it represents potentially a new tool in the treatment of tumors that overexpress the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors, typically found in gynecological cancers, prostate cancer and some forms of breast cancer. Potential benefits of this targeted approach may include enhanced efficacy and a more favorable safety profile with lower incidence and severity of adverse events, as compared to doxorubicin. If Zoptrex™ is approved as a therapy for endometrial cancer, we intend to develop it for these additional indications. In addition, based on the results of Phase 2 studies, we believe that Zoptrex™ holds promise to prove its efficacy for the treatment of ovarian and prostate cancer.”
During the ASCO Annual Meeting, the Company provided an update regarding its progress with Zoptrex™ during one-on-one meetings with oncological key opinion leaders. Dr. Sachse described his interactions with ASCO attendees as promising, stating as follows: “I’m pleased and gratified by the continuing expressions of support for our work on Zoptrex™. The oncologists with whom we met were pleased to learn of our progress toward the completion of our Phase 3 clinical trial and seemed to be as excited as we are about the contribution that our new targeted oncology therapy could make to the treatment of one of the most severe forms of cancer.”
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. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. 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 may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. 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 and clinical trials, 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 rejection or non-acceptance of any new drug application by one or more regulatory authorities and, more generally, uncertainties related to the regulatory process, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the degree of market acceptance once our products are approved for commercialization, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits 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 place undue reliance 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.
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Contacts:
Philip Theodore
Senior Vice President
843-900-3223
ptheodore@aezsinc.com
