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.
Company and Media Contact:
Andre'a Lucca
Director of Communications
PlasmaTech Biopharmaceuticals, Inc.
212-786-6208
alucca@plasmatechbio.com
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SOURCE PlasmaTech Biopharmaceuticals, Inc.