- 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.
About Immunophotonics
Immunophotonics is a biotech company developing a proprietary drug for use in an in situ therapeutic cancer vaccine (inCVAX). inCVAX is a novel investigational immunotherapy approach that utilizes two injections into an accessible tumor, intended to elicit a systemic anti-tumor immune response against the cancer. The first injection primes a tumor to liberate an array of tumor antigens from whole cells, followed by a second injection of GC designed to activate antigen-presenting cells and facilitate the uptake of tumor antigens, which may trigger the desired systemic immune response. Immunophotonics has received funding from Cultivation Capital, BioGenerator, iSelect and the Missouri Technology Corporation to continue the development of its novel investigational technology. Immunophotonics’ vision is to create effective immunotherapies for the treatment of late stage cancer.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/2789a4df-55ad-498d-bd0f-b1cabf9f82a2
Media Contacts: Immunophotonics, Inc. - Lu Alleruzzo, lu@immunophotonics.com, 636.675.6161
