DALLAS and NEW YORK,
July 22, 2014 /PRNewswire/
-- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a developer of
new products for oncology supportive care, announced today that it
has received 510(K) marketing clearance from the U.S. Food and Drug
Administration (FDA) for ProctiGard™, its novel treatment
for symptomatic management of rectal mucositis. The Company
indicated its development of ProctiGard™ is a direct response to
dialogue with the oncology community that is looking for better,
more effective treatment options for rectal mucositis and radiation
proctitis, a debilitating oncology side effect. Access believes
that ProctiGard is a first-in-class treatment option that addresses
a significant unmet medical need. Access currently holds global
commercialization rights for ProctiGard.
"This second FDA marketing clearance is an important milestone
for Access following the decision to focus on the development and
commercialization of a portfolio of follow-on proprietary
products," said Jeffrey Davis, CEO
of Access Pharmaceuticals. He continued, "Rectal mucositis and
radiation proctitis, presenting as inflammation and damage to the
lower part of colon, is a common adverse event of the radiotherapy
of tumors in the abdominal and pelvic region with no
well-established effective standard of care. With the
introduction of ProctiGard™, we look forward to providing cancer
patients with an important treatment that manages this debilitating
disease."
Radiation proctitis (RP) is a condition analogous to oral
mucositis in the oral cavity, concerning the inflammation and
damage to lower parts of the colon following pelvic radiation to
the region. Rectal mucositis, a broader condition, can also be
caused by factors other than radiation, including bacterial, viral
or fungal infections, parasites, contact allergies or food
allergies, and surgery. 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 evaluating
commercialization options for ProctiGard™, including the seeking of
global marketing partners.
About Rectal Mucositis / Radiation Proctitis
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, 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 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. 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.