DALLAS and NEW YORK, Aug. 14, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, has received notification from the Japan Patent Office that a patent for MuGard and ProctiGard has been granted. The patent covers a wide range of liquid formulations for the prevention and treatment of mucosal diseases and disorders.
"Following our recent European licensing agreement with Norgine, the strengthening of our world-wide intellectual property position for MuGard and ProctiGard further supports our commercial efforts and enhances our ability to license both supportive cancer care products in Japan," said Jeffrey Davis, President and CEO of Access. "It is with this in mind that we continue to pursue opportunities within the Japanese market as we believe in the benefit both MuGard and ProctiGard can offer patients when undergoing anticancer treatments."
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 provides the oral mucosa with a thin protective hydrogel layer which has been demonstrated in several clinical studies of mucositis to benefit patients in terms of reduced pain and discomfort as well as a reduction in objective mucositis scores.
Access recently announced that one of the oldest peer-reviewed journals in oncology, the American Cancer Society's journal publication, Cancer, featured MuGard as the cover article of its May 2014 edition. 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," discusses data on Access' post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck. In the trial, MuGard was shown to be superior to the sham control saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis progression. The article can be accessed by clicking on the following link:
About MuGard: 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 also licensed in China, RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
ProctiGard: ProctiGard is a treatment options for rectal mucositis and radiation proctitis, a debilitating oncology side effect. ProctiGard received 510(K) FDA clearance in July 2014. Access currently holds global commercialization rights for ProctiGard.
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.
About Rectal Mucositis / Radiation Proctitis (RP): Rectal mucositis, and specifically radiation proctitis, is the inflammation and damage to the lower portion of the colon, primarily the sigmoid colon and rectum, after exposure to x-rays or ionizing radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon, and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment. Experts believe that RP occurs due to damage to the blood vessels that occurs as part of the radiation therapy.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and ProctiGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.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 Cobalamin, 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 Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
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