Access Pharmaceuticals Advances Development of ProctiGard(TM) for Radiation Proctitis
Leveraging Proprietary Mucoadhesive Polymer Hydrogel Technology to Expand Product Offerings; Seeking Global Marketing Partners
NEW YORK, March 21, 2014 /PRNewswire/ — ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced that it has advanced development of a new proprietary product, called ProctiGard(TM), 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(TM).
“Access is actively developing follow-on products to MuGard® that leverage our powerful mucoadhesive polymer hydrogel drug delivery technology, and ProctiGard(TM) 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(TM) 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(TM) 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 http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
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(TM). Access also has other advanced drug delivery technologies including CobaCyte(TM)-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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