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CHICAGO, June 06, 2019 (GLOBE NEWSWIRE) -- PrimeVax Immuno-Oncology, Inc. announced today that the company has received permission for their Investigational New Drug (IND) Application from the FDA to perform all three of their clinical trials. In a communication yesterday with the agency, the FDA confirmed that they had received the additional information filing from PrimeVax, and that the IND was not on clinical hold.
“At the start of 2019, we signed a collaborative agreement with the US Army to use their dengue virus to treat cancer,” states Tony Chen, PrimeVax’s CEO. “Today, I am proud to report that we have successfully built their dengue virus into our clinical design, and have gained alignment with FDA on this novel therapeutic approach. We are now permitted to test cancer patients for dendritic cells alone, dengue virus alone, and by combining the two.”
PrimeVax’s intended therapeutic effect is to induce fever and other forms of immune activation in cancer patients, in combination with dendritic cell therapy. Last year, the agency granted permission for PrimeVax to begin their clinical trial with dendritic cells first.1
“I have always believed that PrimeVax’s dengue virus would contribute meaningfully to science,” said Bernard A. Fox, PhD, Harder Family Chair for Cancer Research at the Earle A. Chiles Research Institute. “Working with the US Army is a well-considered strategy; their history of managing dengue symptoms and safety data make this virus candidate a reasonable choice for cancer patients. The use of dengue in cancer patients who have failed standard-of-care, yet have not previously been exposed to dengue or other flaviviruses, presents a unique opportunity for us to study the effects of the virus-induced cytokine storm on the development of destructive anticancer immunity in patients who lack that immunity.”
With the IND fully enabled across all three clinical trials of their design, PrimeVax is now finishing getting the hospital sites ready to treat cancer patients.
PrimeVax Immuno-Oncology, Inc. is focused on the development of personalized immunotherapy with its PV-001 platform. PrimeVax’s therapeutic intent is to induce a very strong anti-tumor response using the dengue virus along multiple mechanisms of action, and then redirect that immune effect toward the patient’s own specific tumors. The Company was founded in 2015 and will engage in human clinical trials in 2019. Initial indications to be targeted include metastatic melanoma, triple negative breast cancer, and glioblastoma.
PrimeVax’s clinical trial listing on clinicaltrials.gov.
PrimeVax Immuno-Oncology, Inc.