SAN FRANCISCO--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”) today affirmed its focus on targeted oncologic therapies during the 2016 J.P. Morgan Healthcare Conference, where interest in such therapies remains very strong.
Dr. Richard Sachse, the Company’s Chief Scientific Officer, characterized the interest expressed by oncology companies attending the conference as “intense”, stating as follows: “Immuno-oncology/targeted oncology has been one of the key areas of innovation over the last few years. That is certainly still true today as evidenced by the number of companies presenting developments in this area at J.P. Morgan. We have been at the vanguard of this innovation with our portfolio of targeted oncology compounds, which includes Zoptrex™ (zoptarelin doxorubicin) and our Disorazol Z cytotoxic conjugate, AEZS-138.”
The Company provided an update regarding its progress with Zoptrex™, noting that it recently received DSMB recommendation to continue the ZoptEC Phase 3 clinical program to completion following review of the final interim efficacy and safety data and that the compound met its Phase 2 Primary Endpoint in men with heavily pretreated castration- and Taxane-resistant prostate cancer in an investigator-sponsored study. Commenting on the development status of Zoptrex™, Dr. Sachse stated, “ZoptEC is a fully enrolled Phase 3 study, which we expect to conclude in the second half of 2016. We believe that we are, therefore, a good bit ahead of many of the immune-oncology products that are in development. I would add that Zoptrex™ is a targeted cytotoxic therapy using a peptide as the targeting agent.”
Zoptrex™ is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is D-Lys6-LHRH, a modified natural hormone with affinity for 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. Potential benefits of this targeted approach include enhanced efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin.
The Company is also in the early stages of developing compounds based on another cytotoxic agent that would follow Zoptrex™. The follow-on cytotoxic compound is Disorazol Z, a novel natural compound with outstanding cytotoxic activity that is isolated from the mycobacterium Sorangium cellulosum. Disorazol Z exhibits potent inhibition of tubulin polymerization and has pro-apoptotic properties. It has been shown to arrest cancer cells in G2M stage of the cell cycle at sub-nanomolar concentrations.
“We are focusing on Disorazol Z,” Dr. Sachse explained, “because it is an ideal compound for the formation of cytotoxic conjugates with peptides, proteins and antibodies to selectively target cancer cells. We have one cytotoxic conjugate, AEZS-138, in preclinical development. It is a conjugate based on Disorazol Z and the LHRH receptor agonist that is utilized in Zoptrex™. We believe that the peptide directs the compound specifically to LHRH receptor expressing tumor cells, and mediates binding and uptake via endocytosis. Within the cancer cell, the conjugates are cleaved and Disorazol Z can deploy its potent anti-proliferative activity.”
The Company has patented the cytotoxic agent Disorazol Z in 35 countries, including the United States, Japan, Europe, China, Russia, Korea and Taiwan. This patent protection expires in 2026. The conjugate of Disorazol Z and the LHRH receptor agonist as a targeted cytotoxic agent is patented in 15 countries, including the United States, Japan, China, Russia, Korea and Taiwan. This patent protection expires in 2027. The Company expects the European patent to be granted in the near future.
Mr. David A. Dodd, Chairman, President and CEO of the Company commented on the Company’s business development efforts, saying “With the recent DSMB recommendation that we complete our ZoptEC Phase 3 study of Zoptrex™, we have seen greatly increased interest from companies in commercializing the product in markets outside the United States for its current indication and follow-on indications. Several of these companies are also interested in evaluating Disorazol Z. While much work remains to be done, we are hopeful that we can bring one or more transactions to conclusion.”
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 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, 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.
