About MVK Pharmaceuticals
Dr. Michael Kubek (US Army veteran), first outlined the idea of intranasal delivery of TRH nanoparticles with Dr. Abraham (Avi) Domb (Israeli Army veteran) in 2000 at a military health conference in Israel. The idea of commercializing intranasal delivery of TRH nanoparticles to treat behavioral disorders began in 2007 when then CAPT Neal Naito, Director of Public Health, US Navy, cold called Dr. Michael Kubek about joining a research team to submit a proposal to DARPA for treating TBI and associated co-morbidities among military members and veterans. Although the proposal was not funded by DARPA, the partnership between Dr. Naito and Dr. Kubek eventually resulted in DoD funding for an anti-suicide project beginning in 2012.
Mr. Christopher Browning (US Marine Corps veteran and Indiana Army National Guardsman) was recruited by Dr. Kubek to provide research/business support and development services. GMP TRH nanoparticles were successfully synthesized in 2014 and a FDA pre-IND meeting was conducted in 2014.
Preclinical animal toxicity studies were completed in March 2017 and a licensing option agreement between MVK Pharmaceuticals and Indiana University Research and Technology Corporation on the IP is currently under construction.
The Phase I clinical trial protocol is finalized and is in preparation for HRPO regulatory review in anticipation for FDA IND submission for Fast Track designation in 4Q 2017.
MVK Pharmaceutical's seeks to build growth through the intranasal nanomedicine platform for use to deliver neuropeptides to revolutionize the standard of care in CNS disorders.
MVK Pharmaceutical's is a unique veteran owned pharmaceutical company seeking to help military members, their families, veterans, and civilians beat suicide and other mental health disorders.