Arrowhead Files For Regulatory Permission To Begin Phase 1 Trial Of RNAi; TapImmune Announces Phase II Clinical Trials with VGTI Florida Print E-mail
By Marilyn Mullen   
Tuesday, 18 November 2014 19:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 18, 2014.
Arrowhead Research Corporation (NasdaqGS: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it recently filed an application for approval to begin a Phase 1 clinical trial of its RNAi-based therapeutic candidate, ARC-AAT, for the treatment of liver disease associated with alpha-1 antitrypsin deficiency.
Pending approval, Arrowhead intends to proceed with a double blind, placebo-controlled dose escalation, Phase 1 study to determine the safety, tolerability, pharmacokinetics and effect on circulating alpha-1 antitrypsin levels of ARC-AAT in healthy volunteers and patients with alpha-1 antitrypsin deficiency. The study is planned to start in Australia in healthy volunteers and will dose escalate until predetermined levels of alpha-1 antitrypsin reduction are reached. Once these levels of protein knockdown are achieved, the study will transition into a population of patients with ZZ genotype alpha-1 antitrypsin deficiency to further evaluate escalating doses of ARC-AAT. The study is designed to enroll up to 48 subjects, including healthy volunteers and alpha-1 antitrypsin deficiency patients.
The application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration. 
 
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TapImmune, Inc. (OTCQB: TPIV), is pleased to announce a new collaborative research agreement with The Vaccine & Gene Therapy Institute of Florida (VGTI Florida), a leading, non-profit biomedical research institute, forming a partnership to advance TapImmune's proprietary,  cancer vaccines into  Phase II human clinical trials for the treatment of breast and ovarian cancers. 
These highly promising therapeutic cancer vaccine candidates were developed by VGTI Florida's Director of Cancer Vaccines and Immune Therapies Program, Keith Knutson, Ph.D.  The goal is to prevent breast and ovarian cancer recurrence for patients who achieve remissions following standard-of-care treatment.  The vaccine works by enabling the immune system to target and
eradicate any residual cancer cells or newly arising cancer cells that express the antigens delivered by the vaccine.   TapImmune has already announced interim data on both clinical programs that exceeded its expectations for immune responses in the treated patients.
VGTI Florida will work with TapImmune to design and

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execute the Phase II clinical programs.  This includes the design of the clinical protocols, selection of clinical trial sites, recruitment of key opinion leaders as clinical advisors, and selection of external manufacturing and
clinical resources.
TapImmune had previously announced the licensing of these vaccines technologies for the treatment of HER2/neu breast cancer and ovarian and breast cancer developed in the laboratory of Dr. Keith Knutson while at the Mayo Clinic.
TapImmune's CEO, Glynn Wilson commented: "We are delighted to establish this collaboration with the Center for the Diseases of Aging at VGTI Florida to expand our relationship with Dr. Keith Knutson and leverage their unique experience in breast and ovarian cancer vaccine development and clinical trial design as we move our clinical programs into Phase II trials." 
Also Tuesday:
 
ADMA Biologics, Inc. (Nasdaq:ADMA), today announced the opening of its second plasma collection facility in Marietta, Georgia.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today reported financial results for the quarter ended September 30, 2014.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that Roy E. Beauchamp, U.S. Army Lieutenant General (retired) was elected to Authentidate's Board of Directors, expanding the number of directors from six to seven.
Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced positive data from the laboratory of Eduardo Marbán, M.D., Ph.D., Capricor's Scientific Advisory Board Chairman and the Director of the Cedars-Sinai Heart Institute. 
Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, announced yesterday at the American Heart Association's Annual Scientific Sessions 2014, the one-year results of the Phase I ALLSTAR (Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration) clinical trial, which indicate that intracoronary injection of allogeneic cardiosphere-derived stem cells (CAP-1002) to achieve myocardial regeneration in patients with left-ventricular dysfunction who have had an anterior myocardial infarction appears to be safe, with no deaths, no acute myocarditis and no major adverse cardiac events.
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today announced that the Company's management will be participating in two upcoming investor conferences.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today announced that Thomas M. Patton, President and Chief Executive Officer, will present at the seventh annual LD MICRO MAIN EVENT conference on Tuesday, December 2, 2014, at 11:00 a.m. Pacific time. 
Cellular Dynamics International (CDI) (Nasdaq:ICEL) today announced the publication1 of a study in the American Journal of Transplantation describing a key first step in ultimately rebuilding and eventually transplanting organs: recreating a portion of the blood supply infrastructure. Jason Wertheim, M.D., Ph.D., Assistant Professor of Surgery-Organ Transplantation at Northwestern University Feinberg School of Medicine, used CDI's iCell® Endothelial Cells to coat the blood supply system of a kidney scaffold, which is crucial for circulation and nutrient distribution throughout the tissue of any organ. 
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced the launch of CombiPGS™, a preimplantation genetic screening (PGS) test for women undergoing in vitro fertilization (IVF). 
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that it has completed patient enrollment in the EVAS FORWARD-IDE clinical trial, the Company's U.S. pivotal clinical trial designed to evaluate the safety and effectiveness of the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System") for the endovascular repair of infrarenal abdominal aortic aneurysms ("AAA"). 
Fibrocell Science, Inc., (Nasdaq:FCSC), an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced the U.S. Food and Drug Administration is allowing the company's investigational new drug (IND) application to proceed for developing a new treatment for amputee stump skin to prevent skin diseases that lead to prosthesis abandonment.
Forward Pharma A/S (Nasdaq:FWP) announced today that it has filed a lawsuit against Biogen Idec GmbH, Biogen Idec International GmbH and Biogen Idec Ltd. in the Regional Court in Dusseldorf, alleging infringement of its German utility model DE 20 2005 022 112 due to Biogen Idec's marketing of Tecfidera® in Germany.
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, today announced the completion of enrollment in the GALE-401, or Anagrelide Controlled Release, Phase 2 Clinical Trial. 
Intellipharmaceutics International Inc.  (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that it has appointed Domenic Della Penna as its new Chief Financial Officer ("CFO") effective November 24, 2014.
Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced upcoming oral presentations related to KTE-C19, the Company's most advanced product candidate, that will take place at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco, California, December 6-9, 2014. 
Protea Biosciences Group, Inc. (OTCQB:PRGB) announced today that it has reported financial results for its third quarter ended September 30, 2014. 
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that the company will participate in the following conference:  Julie Anne Smith, President and Chief Executive Officer-Designate, will present at the 26th Annual Piper Jaffray Healthcare Conference on Tuesday, December 2, 2014, at 9:10 a.m. ET/6:10 a.m. PT at The New York Palace, New York, NY.
RedChip Companies, Inc., today announced it has issued a research update on OxySure Systems, Inc. (OTCQB:OXYS), a medical technology company that develops, markets, and sells life-saving, easy-to-use medical devices.
Sangamo BioSciences, Inc. (Nasdaq:SGMO) announced today that Edward Lanphier, Sangamo's president and CEO, will provide an update on the progress of Sangamo's ZFP Therapeutic® development programs and an overview of the company's business strategy at 8:00 am ET on Tuesday, December 2, 2014, at the 26th Annual Piper Jaffray Healthcare Conference in New York.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 26th Annual Piper Jaffray Healthcare Conference in New York City on Tuesday, December 2nd at 10:30am (EST).
Vital Images, Inc., announces enhancements in image management to its industry-leading VitreaView® enterprise viewer with VioStream™ software. 



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