Ovarian Cancer News Today recently featured Hemispherx in a story about the ongoing clinical trials at the University of Pittsburgh Medical Center using our drug Ampligen to develop a more effective treatment for recurrent ovarian cancer. In an April 30 press release, we announced significant progress based on an interim clinical trial report of Ampligen in combination with cisplatin in advanced ovarian cancer. The report from the trial’s Principal Investigator, Dr. Robert Edwards, provided data consistent with increasing genes associated with anti-tumor immunity.
As stated in the story “Ampligen — approved in Argentina for severe cases of chronic fatigue syndrome — is an immune modulator that activates part of the immune system and is thought to assist in immune infiltration within the tumor. In cellular models, Ampligen promoted an accumulation of killer T-cells, which are immune cells that attack cancerous ones, without attracting regulatory T-cells (T-regs) – potent immunosuppressive cells that promote the progression of cancer through their ability to limit the anti-tumor immune response.”
The data supporting the favorable change in the tumor microenvironment (TME) by Ampligen were derived from ovarian cancer tumor explant studies (See here.) and a Phase I trial of patients with colorectal carcinoma at the UPMC (unpublished data of Dr. P. Kalinski et al.). These data demonstrate that Ampligen increases the Teff cell to Treg cell ratio in the TME, thereby converting “cold” tumors into “hot” tumors, which are believed by experts in the field to have an increased likelihood of responding to checkpoint blockage drugs, such as pembrolizumab, the checkpoint drug being used in the study (See: ClinicalTrials.gov). The significant progress occurring in our Ampligen Ovarian Cancer Program as reported in the Ovarian Cancer News Today relates to the safety data showing that intraperitoneal Ampligen is generally well tolerated in patients with recurrent ovarian cancer, as well as the initiation of the Phase II study at UPMC that will evaluate Ampligen in up to 45 patients with ovarian cancer in combination with the checkpoint blockade drug, pembrolizumab, which is being supplied by Merck.
Ovarian cancer is projected to kill 152,000 this year worldwide. Recurrent ovarian cancer is a dire unmet medical need. Working with the University of Pittsburgh, we are able to team up and focus world-class science on developing a meaningful combination therapy with the potential to save the lives of women who may be out of therapeutic options.
Read the full story at OvarianCancerNewsToday.com.