News

New Publication Describes ch-mAb7F9 Bioequivalence Studies

InterveXion and UAMS have published a new manuscript describing the development of the ch-mAb7F9 antibody and early studies demonstrating it’s bioequivalence to the murine mAb7F9. Abstract - Ch-mAb7F9, a human-mouse chimeric monoclonal antibody (mAb) designed to bind (+)-methamphetamine (METH) with high affinity and specificity, was produced as a […]

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FDA grants meeting to discuss Phase 1a results and plans for Phase 1b

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 […]

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All Planned Follow-Ups Completed in First Human Study of ch-mAb7F9

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 […]

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InterveXion Completes Planned Dosing in Phase 1a Study of ch-mAb7F9

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 […]

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A Vaccine to Curb Addicts’ Highs

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…

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First Human Subject Dosed in Phase 1a Study of ch-mAb7F9

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 […]

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InterveXion’s First IND Application Becomes Active

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 […]

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NIDA Funds the First Clinical Trial of an Anti-Methamphetamine Antibody

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.

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InterveXion Conducts a Successful Pre-IND Meeting for Anti-Methamphetamine ch-mAb7F9

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 […]

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ARRA Grant Award to Fund Development of Anti-METH mAb

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 […]

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