PHILADELPHIA, July 10, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced that 12 pancreatic patients are currently undergoing treatment with single-agent Ampligen immuno-oncology therapy in an Early Access Program (EAP) managed by Amsterdam-based myTomorrows, an international leader in providing physician access to experimental medicines.
Eight of the 12 patients entered the EAP with metastatic disease (late stage) and have been on drug for 12 weeks or longer. The four other patients entered the program in the last several weeks with earlier stage disease.
The program is being conducted at Erasmus Medical Center in Rotterdam under the supervision of lead clinician C.H.J. (Casper) van Eijck, MD, a noted Dutch oncologist specializing in pancreatic cancer.
“Ampligen has been shown in numerous earlier studies to possess both tumor-killing and immuno-modulating activity, the two characteristics that form the basis of immuno-oncology therapy. This is developing into one of the fastest growing and promising forms of cancer treatment,” noted Thomas K. Equels, CEO of Hemispherx.
He continued, “The program at Erasmus is intended to see if Ampligen’s immuno-modulating properties correlate to disease progression and increased survival of pancreatic cancer patients who have run out of conventional therapeutic options. We are very pleased with the progress so far. As evidenced in our many prior clinical studies, Ampligen appears to be generally well-tolerated by the pancreatic patients in this program.”
The EAP program in the Netherlands is designed to treat up to 50 pancreatic patients with government funding to compensate Hemispherx for the experimental use of Ampligen in the program. Top line data from the program is expected to be reported before year-end.
Hemispherx and myTomorrows are working together on plans to expand early access to Ampligen to other European countries with full government reimbursement.
Separately, Hemispherx is laying plans for cancer trials of Ampligen in the U.S.
Mechanistically, Ampligen’s Toll-like Receptor 3 mechanism activates the innate and adaptive immune systems and, as such, modulates the tumor microenvironment, potentially enhancing tumor-killing activity and patient survival rates.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics rintatolimod (tradenames Ampligen® or Rintamod®) and Alferon® LDO. Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both rintatolimod and Alferon® LDO are experimental in nature, they are not designated safe and effective by the FDA for general use and are legally available only through clinical trials.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, no assurance can be given as to the ultimate results of the Ampligen pancreatic cancer therapy trial discussed herein on a more long term basis or with a much larger pool of recipients. While we are planning possible cancer trials of Ampligen in the U.S., we will need significant additional funding to commence and conduct such studies. Expansion of the Early Access Program with myTomorrows into pancreatic cancer is no assurance of commercial approval in the US or elsewhere. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.