Aeterna Zentaris Adds Hollings Cancer Center To Multi-National Phase 3 Trial; Marina and Mirna Amend License Agreement Print E-mail
By William Kent   
Thursday, 20 November 2014 20:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 20, 2014.
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.

 
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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.”


 
Also Thursday:


 
AXIM Biotechnologies (OTC:AXIM)
brings to market global innovative solutions that set the "green standard" in the industrial hemp industry.

BG Medicine, Inc. (Nasdaq:BGMD)
, the developer of the BGM Galectin-3® Test, announced today that 17 abstracts reporting independent research that investigates galectin-3 testing in various cardiovascular diseases have been presented at the American Heart Association's 2014 Scientific Sessions and Resuscitation Science Symposium, which was held in Chicago, Illinois during November 15-19, 2014.

ChemoCentryx, Inc., (Nasdaq:CCXI)
, a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, reported today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for CCX168, an orally administered inhibitor targeting the receptor for the complement protein known as C5a (C5aR).

CNS Response, Inc. (OTCBB:CNSO)
CNS Response Chairman Thomas Tierney and CEO George Carpenter provided testimony in support of HR 5059, the Clay Hunt Suicide Prevention for American Veterans Act, at the request of the of the House Veterans Affairs Health Subcommittee on Health.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, which develops, assembles, markets and sells medical devices and wearable sleep respiratory products in China, today announced that it has signed a new software license and strategic cooperation agreement (the "New Agreement") with Israel-based WideMed Technologies Ltd. ("WideMed") during the MEDICA trade fair ("MEDICA"), which took place November 16 -19, 2014 in Düsseldorf, Germany.

Endologix, Inc. (Nasdaq:ELGX),
developer and marketer of innovative treatments for aortic disorders, announced today the presentation of initial clinical data from the Company's EVAS FORWARD – Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms ("AAAs") who were treated with the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System").

FutureWorld Corp. (OTCQB; FWDG)
, a leading provider of advanced technologies and solutions to the global cannabis industry, announces today that it is depositing 20,000,000 shares of common stock of CB Scientific, Inc. ("CB Scientific") with a trust formed for the benefit of holders of FutureWorld' common stock. 

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care announced today the execution of a purchase agreement for up to $55.0 million with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospital medicine and post-acute physician group practice company, announced today that it is continuing its investment in the acute and post-acute care market with the acquisition of Hospital Practice Associates, Inc.(HPA), in Jacksonville, Florida.

Lombard Medical, Inc. (Nasdaq:EVAR)
, a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today presented efficacy and safety data from the two-year follow up of the U.S. PYTHAGORAS pre-marketing approval (PMA) trial of Aorfix™, the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees.

Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), an emerging biopharmaceutical company focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions, today announced that Roelof Rongen, President and Chief Executive Officer, will be presenting a corporate overview highlighting the recent clinical progress of Matinas BioPharma's lead product candidate MAT9001 at two upcoming investor conferences during the first week of December of 2014.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax' RSV F-Protein nanoparticle vaccine candidate (RSV F vaccine) for protection of infants via maternal immunization.

Otonomy, Inc. (Nasdaq:OTIC)
, a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that David A. Weber, Ph.D., president and CEO, will present at the 26th Annual Piper Jaffray Healthcare Conference on Wednesday, December 3, 2014 at 2:00 p.m. ET at The New York Palace in New York City.

PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, today announced that its Chairman and CEO, William J. Caragol, will present at the LD Micro Conference on December 2, 2014, at 4:30 PM PST / 7:30 PM EST, at the Luxe Hotel in Los Angeles.

REVA Medical, Inc. (ASX:RVA)
is pleased to announce that the financing transaction approved by the Company's shareholders at the Special Meeting of Stockholders held in Sydney, Australia on October 31, 2014, has been successfully completed.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that its management is scheduled to participate in the 26th Annual Piper Jaffray Healthcare Conference.

Sientra, Inc. (Nasdaq:SIEN)
, a medical aesthetics company, today announced its financial results for the third quarter and nine months ended September 30, 2014.

Symmetry Medical Inc. (NYSE:SMA)
, a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that Thomas J. Sullivan, President and Chief Executive Officer, is scheduled to participate in a fireside chat presentation at the 26th Annual Piper Jaffray Healthcare Conference in New York, NY.




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