DALLAS and NEW YORK, March 5, 2015 /PRNewswire/ -- PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI), a biopharmaceutical company advancing protein biologic therapies and oncology supportive care products, announced today that enrollment has begun in a clinical trial at UCLA's Jonsson Comprehensive Cancer Center that is evaluating MuGard in the prevention and treatment of stomatitis in breast cancer patients using everolimus (marketed by Novartis Oncology under the tradename Afinitor®). The title of the trial is "Phase II Randomized Trial of MuGard Compared With Best Supportive Care for Prevention and Treatment of Stomatitis in Women With Hormone Receptor Positive Breast Cancer Initiating Treatment With Everolimus-based Endocrine Therapy" and details on the trial design and enrollment can be found on its clinicaltrials.gov, under the identifier NCT02015559.
Commenting on the trial, David Nowotnik, Ph.D., PlasmaTech's Senior Vice President, Research and Development stated, "The Company is pleased to see that the clinical community continues to evaluate usage, and expand the body of clinical evidence, that supports the use of MuGard in the treatment of patients experiencing the debilitating side effect of oral mucositis and stomatitis. The Company believes that the incidence of oral mucositis, and it problems it causes for patients and patient compliance, continues to grow as important new therapies such as everolimus expand commercially. MuGard offers clinicians an important option in the management of this challenging side effect."
PlasmaTech previously announced the publication of positive MuGard clinical data in the May 2014 issue of Cancer, the journal of the American Cancer Society. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available to the public at http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is licensed in Korea through Hanmi Pharmaceutical and in Europe, Australia and New Zealand through Norgine, B.V.
About PlasmaTech: PlasmaTech is a biopharmaceutical company focused on advancing protein biologic therapies and oncology supportive care products. Exploiting two proprietary platforms, Salt Diafiltration (SDF™) Process and Polymer Hydrogel Technology (PHT™), PlasmaTech is active in the development and commercialization of human plasma-derived therapeutics, including its proprietary alpha-1 protease inhibitor, SDF Alpha™. The company has a robust product pipeline that includes two commercial stage products, MuGard® and ProctiGard™, and follow-on products in development. For more information, visit www.plasmatechbio.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and ProctiGard, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to PlasmaTech's need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in PlasmaTech Bio's Annual Reports on Form 10-K and other reports filed by the Company with the Securities and Exchange Commission.
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