Immunophotonics, Inc. Announces First Patient Dosed in a Randomized, Controlled Breast Cancer Clinical Trial for inCVAX – A Novel Investigational Immuno-Oncology Therapy
This South American, phase 2/3 clinical trial will enable Immunophotonics to further advance the investigation of inCVAX, which is intended to be a specific, systemic, and targeted immuno-oncology treatment for metastatic tumors
ST. LOUIS, Aug. 23, 2016 (GLOBE NEWSWIRE) -- Immunophotonics today announces that it has dosed its first patient in a randomized & controlled clinical trial to further evaluate the efficacy of its developing cancer vaccine, inCVAX.
“The initiation of this clinical trial in South America marks a substantial milestone for the company. It significantly advances the development of a potential new treatment option for patients with late-stage cancer,” Dr. Bobby W. Sandage. Jr., Chairman of the Board for Immunophotonics stated.
Immunophotonics, Inc. is a biotech company developing a proprietary drug (GC, N-dihydro-galacto-chitosan) for use as a therapeutic cancer vaccine (inCVAX) for the potential treatment of metastatic tumors. inCVAX is a novel investigational immuno-oncology (IO) therapy that is designed to stimulate the patient’s own immune system to kill cancer cells.
In a previous investigator-initiated clinical trial in Peru, several advanced breast cancer patients experienced a reduction of both the treated tumors as well as distant, untreated metastases. In some cases, the intervention led to a complete elimination of the tumors. These results persuaded the Peruvian regulatory authorities to approve a 246 patient randomized, controlled clinical trial assessing the efficacy of inCVAX in late-stage breast cancer patients.
Lu Alleruzzo, Co-Founder & President commented, “We were encouraged by the investigator initiated first-in-human results and are excited to have initiated this follow-on clinical trial. The clinical investigators are eager to enroll patients and we expect to have preliminary results available sometime in Q2-2017.”
While Immunophotonics is focusing its current clinical efforts on advanced breast cancer in South America, our data suggests that inCVAX may have broad applicability to several solid tumor indications. A US Investigational New Drug submission is planned for 2017. Other indications, based on preclinical research - including advanced melanoma - are currently under evaluation by the Immunophotonics team.