Access Pharmaceuticals Advances Development of ProctiGard™ for Radiation
Leveraging Proprietary Mucoadhesive Polymer Hydrogel Technology to Expand
Product Offerings; Seeking Global Marketing Partners
NEW YORK, March 21, 2014
NEW YORK, March 21, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB:
ACCP) announced that it has advanced development of a new proprietary product,
called ProctiGard™, for the treatment of radiation proctitis. Radiation
proctitis ("RP") is a significant unmet medical need, with no well-established
standard of care. It is estimated that there are in excess of 250,000 new
cases of prostate, cervical, rectal, testicular, bladder and endometrial
cancer diagnosed each year. Approximately 50% of these patients require
radiation therapy, and roughly 75% of patients undergoing pelvic irradiation
experience radiation proctitis. Access is actively seeking marketing partners
globally for ProctiGard™.
"Access is actively developing follow-on products to MuGard® that leverage our
powerful mucoadhesive polymer hydrogel drug delivery technology, and
ProctiGard™ is the first example of this development effort," stated Jeffrey
B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Radiation
proctitis is a condition somewhat analogous to oral mucositis, concerning the
damage and ulceration of the mucosal tissue of the digestive tract. The
development of ProctiGard™ is a direct response to dialogue with the oncology
community that is looking for better, more effective treatment options for
this debilitating oncology side effect."
Davis continued, "Access intends to follow the MuGard^® development and
commercialization strategy with ProctiGard™ by progressing manufacturing
scale-up, the signing of multiple commercialization partners here in the US
and abroad, and the completion and successful publication of supportive,
positive clinical data similar to the recently published MuGard^® clinical
trial data in Cancer."
About Radiation Proctitis: 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, and symptoms include
diarrhea, nausea, cramps, urgency, mucus discharge and painful defecation.
Experts believe that RP occurs due to damage to the blood vessels that occurs
as part of the radiation therapy.
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 was
launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug
Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United
States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea.
Clinical data on MuGard^®, entitled "Multi-Institutional, Randomized, Double
Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive
Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being
treated With Chemoradiation Therapy for Cancers of the Head and Neck," was
recently published online at
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
is developing multiple follow-on products including ProctiGard™. 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
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
Company and Media Contact:
Access Pharmaceuticals, Inc.
SOURCE Access Pharmaceuticals, Inc.
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