InterveXion has been granted a meeting with FDA in January 2014 to discuss the development program for ch-mAb7F9. The purpose of the meeting is three-fold: 1) to discuss the results of the Phase 1a study, 2) to confirm that the proposed nonclinical studies will support a Phase […]
Read more →InterveXion Therapeutics reports that all subjects have completed all planned follow-up appointments in the first clinical study of ch-mAb7F9, the company’s first investigational anti-methamphetamine antibody product. Forty-two (42) non-METH using volunteer subjects were dosed with antibody or placebo in the study starting in May 2012. Because of […]
Read more →LITTLE ROCK – InterveXion Therapeutics LLC and the University of Arkansas for Medical Sciences (UAMS) have successfully completed dosing in the first human safety study of a medication to help methamphetamine users fight their addictions. The medication is expected to significantly reduce or prevent the euphoric rush […]
Read more →Chief Scientific Officer, Mike Owens, Ph.D., was quoted in the Wall Street Journal discussing the potential of anti-methamphetamine antibodies to be available in the right amount at the right time. Read the essay…
Read more →The first subjects have been successfully dosed in InterveXion’s Phase 1a clinical safety study of ch-mAb7F9 in healthy human volunteers. Expected enrollment is 40 subjects in this escalating dose protocol covering doses from 0.2-20 mg/kg. InterveXion expects to complete dosing by fall and have preliminary data in […]
Read more →An IND for InterveXion’s chimeric anti-METH monoclonal antibody, ch-mAb7F9, was submitted to FDA in March and became active in early April. Plans for the Phase 1a clinical study in healthy volunteers are being finalized and we expect to begin screening potential subjects in mid-April. This study will […]
Read more →A grant to fund the First in Human, Phase 1a clinical study of anti-METH ch-mAb7F9 was awarded to UAMS and InterveXion. This three year, $3 million, award will be used to test the safety of the chimeric antibody in healthy human volunteers.
Read more →On April 26, 2011 the company had a productive meeting with the FDA to discuss the impending IND application for ch-mAb7F9 as a treatment for chronic METH use. The discussion centered around the toxicology program and antibody characterization techniques. InterveXion believes the Agency’s comments will be satisfactorily […]
Read more →InterveXion has been awarded a two year $3.9 million grant entitled “Chimeric anti-Methamphetamine Monoclonal Antibody for Treating Stimulant Toxicity” by the National Institutes of Health, National Institute on Drug Abuse (NIDA) as part of the American Recovery and Reinvestment Act of 2009. W. Brooks Gentry, M.D. and […]
Read more →InterveXion met with the FDA on September 29, 2009 to discuss plans for a Phase 1 clinical trial of the PCP antibody ch-mAb6B5. InterveXion’s management team was present with its regulatory consultant from Quintiles, Dr. Raj Kishore, and members of the NIDA management group as attendees. The […]
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