|Aeterna Zentaris Adds Hollings Cancer Center To Multi-National Phase 3 Trial; Marina and Mirna Amend License Agreement|
|By William Kent|
|Thursday, 20 November 2014 20:54|
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) announced the opening of a new clinical site at the Hollings Cancer Center of the Medical University of South Carolina in Charleston, South Carolina, for the Company's ongoing multinational, pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer. The Hollings Cancer center is the only National Cancer Institute designated cancer center in South Carolina and the state's largest academic‑based cancer program. Furthermore, the Company announced that patient recruitment for this trial now stands at over 320 patients out of a projected total of 500 patients.
David Dodd, Chairman, CEO at Aeterna Zentaris stated, "Patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer, our lead oncology program, is in line with our projected timelines to secure a first interim analysis in the first half of 2015 by an independent Data Safety Monitoring Board. Today, there is no FDA approved therapy for treating women suffering from advanced, recurrent or metastatic endometrial cancer. Our hope is that our novel product will be successful in this trial and subsequently, become a core tool in improving the lives of women with this type of cancer. Also, we are very pleased to be working with the Hollings Cancer Center at the Medical University of South Carolina for this trial, and look forward to other future collaborations with this most prestigious institution as part of our plan to establish activities in the Charleston area, one of the most thriving and exciting business communities in the United States."
Jennifer Young Pierce, MD, Assistant Professor of Obstetrics & Gynecology and Principal Investigator at the Hollings Cancer Center, Medical University of South Carolina added, "Metastatic endometrial cancer is a devastating disease, and we see a disproportionate number of cases at Hollings Cancer Center. Given the limited therapeutic options for these patients and few clinical trials available, we are especially excited to collaborate with Aeterna Zentaris to offer our patients this promising new therapy."
The ZoptEC Phase 3 trial in endometrial cancer -- This is an open-label, randomized, multicenter Phase 3 trial currently being conducted in North America, Europe and Israel, under a Special Protocol Assessment, comparing zoptarelin doxorubicin with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. Lead investigators are David Scott Miller, MD, from the University of Texas Southwestern Medical Center, in Dallas, Texas, and Hani Gabra, MD, from the Imperial College London Hammersmith Campus in London, England. The trial will involve over 120 sites and approximately 500 patients with improvement in median overall survival as the primary efficacy endpoint. To date, more than 120 sites are in operation and more than 320 of the expected 500 patients have been entered into the trial.
Selected as the contract clinical development organization, Ergomed will also assume 30% (up to $10 million) of the clinical and regulatory costs for this trial.
Marina Biotech, Inc. (OTC Pink: MRNA), a leading oligonucleotide-based drug discovery and development company, and Mirna Therapeutics, Inc. (Mirna), a privately-held biotechnology company pioneering microRNA (miRNA) replacement therapy for cancer, announced they have amended their license agreement regarding the development and commercialization of microRNA-based therapeutics utilizing Mirna’s proprietary microRNAs and Marina Biotech’s novel SMARTICLES liposomal delivery technology. Under terms of the amendment, Mirna paid certain pre-payments to Marina Biotech and now has additional rights to its lead program, MRX34, currently in Phase 1 clinical development for patients with unresectable primary liver cancer or metastatic cancer with liver involvement. In addition, under the terms of the license agreement, Mirna has optioned exclusivity on several additional miRNA targets. Further terms of the Agreement were not disclosed.
“Mirna and Marina Biotech have enjoyed a successful, durable collaboration by leveraging the systemic delivery of our proprietary, double-stranded, miRNA mimics with the SMARTICLES delivery technology,” said Paul Lammers, President and CEO of Mirna Therapeutics. “Amendment of the license agreement strengthens the potential medical and commercial value of MRX34 as the first miRNA mimic to enter the clinic in cancer, and provides exclusivity for the use of SMARTICLES with other highly promising tumor suppressor miRNAs.”
“We are extremely pleased with our on-going relationship with Mirna as a forerunner in the human clinical development of microRNA-based therapeutics,” stated J. Michael French, President and CEO of Marina Biotech. “We are also pleased about our ability to successfully close licensing transactions during the past year and a half, which has allowed us to keep the company moving forward during a difficult stretch. Although this transaction will not allow us to resume normal operations, I believe it will be sufficient to achieve certain tactical and strategic objectives over the next quarter. We have witnessed over the past several months increasing interest across the broader pharmaceutical sector in the application of our drug discovery engine to the development of nucleic acid-based therapeutics for rare and orphan diseases. We are excited about this increased awareness of our capabilities and hope to capitalize on these developments in the future.”
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