Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance For ProctiGard™ New product offers treatment to significant unmet medical need in supportive cancer care
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:
VP Corporate Development
Access Pharmaceuticals, Inc.
SOURCE Access Pharmaceuticals, Inc.