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:
http://onlinelibrary.wiley.com/enhanced/doi/10.1002/cncr.28553/
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.
Company and Media Contact:
Christine Berni
VP Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6208
SOURCE Access Pharmaceuticals, Inc.