AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) 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.” (Original Source)
Shares of Aeterna Zentaris are up nearly 8% to $3.90 in after-hours trading. AEZS has a 1-year high of $31.38 and a 1-year low of $2.60. The stock’s 50-day moving average is $3.67 and its 200-day moving average is $4.06.
On the ratings front, Aeterna has been the subject of a number of recent research reports. In a report issued on April 28, Maxim Group analyst Jason McCarthy reiterated a Buy rating on AEZS, with a price target of $11, which represents a potential upside of 204.7% from where the stock is currently trading. Separately, on March 31, Canaccord Genuity’s Neil Maruoka reiterated a Buy rating on the stock and has a price target of $9.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Neil Maruoka have a total average return of 7.5% and -31.1% respectively. McCarthy has a success rate of 52.8% and is ranked #484 out of 3894 analysts, while Maruoka has a success rate of 18.2% and is ranked #3887.
Ãterna Zentaris, Inc. operates as a specialty biopharmaceutical company that is engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. The company’s pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. It focuses on the development of Perifosine, Cetrotide, Ozarelix, AEZS-108 and AEZS-130.