Products

Business Vision
InterveXion Therapeutics LLC was founded in Little Rock, Arkansas in 2004 to use its proprietary hapten technology to produce antagonist therapies that neutralize toxins in the body and improve patient health.

InterveXion’s is developing and commercializing therapies for treatment of substance abuse from PCP and methamphetamine. Abuse of these stimulants is increasing and no specific therapies are currently available for treatment.

Therapeutic Products
InterveXion Therapeutics is developing PCP-mAb for the treatment of PCP abuse and METH-mAb for the treatment of methamphetamine abuse. These therapies are monoclonal antibodies (mAbs) that can “absorb” these toxins in the bloodstream to reduce the acute effects of overdose and can also be used in the chronic setting to help abusers overcome their dependency. The development and approval of these drugs will provide a strong scientific, regulatory and financial basis to extend the use of passive monoclonal therapy for neuroprotection and other protective therapies.

The Technology
InterveXion Therapeutics will commercialize two therapies for the the treatment of substance abuse from PCP and Methamphetamine. Our products are monoclonal antibody (mAb) medications that tightly bind to dangerous drugs in the blood stream and restrict their transport into the brain. This blocks the rewarding effects and reduces damage to health. They can be combined with counseling therapy for treatment of addiction or used in the emergency room to reduce the amount of drug in a patient’s brain. Our first two products are: PCP-mAb for treating PCP abuse, and METH-mAb which could be used to treat METH, AMP or MDMA abuse. Animal studies have produced significant preclinical results showing the feasibility of treating addiction-related diseases with mAb therapy.

With technology that allows the discovery and development of molecules that bind specific small molecules, InterveXion is also pursuing prevention of toxicities that have bio-defense applications.

This technology, representing over two decades of work, is the basis for an exclusive license agreement between InterveXion and the University of Arkansas for Medical Sciences (UAMS).
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Clinical Development
InterveXion's therapies will have a short clinical path due to the proven safety of monoclonal antibody therapies and the unmet medical need for these treatments. At this point there are no specific medications coming forward for the treatment of methamphetamine and PCP abuse. Our mAb therapies could be approved in three to four years with a fast-track designation by FDA.

InterveXion expects to file its first IND during 2010and start the PCP-mAb Phase I trial in 2011. InterveXion is scaling-up cGMP production of both PCP and Meth-mAb clinical materials. The IND for Meth-mAb is expected to be filed in early 2012.

The pre-clinical research leading up to this IND is very extensive and well documented in peer-reviewed scientific publication by InterveXion’s co-founder and Chief Scientific Officer, Dr. Michael Owens, at UAMS. This gives the opportunity to bring a new drug from the laboratory to the clinic in a very short time.

National Institute on Drug Abuse (NIDA) Collaboration and Funding
The Company has been awarded one of largest Small Business Technology Transfer (STTR) grants given by National Institute of Drug Abuse (NIDA) part of the National Institutes of Health (NIH). This grant is a “Fast Track”, Phase I and Phase II award for approximately $3.1 million over a period of five years for the development and initial production of PCP-mAb, the company’s lead molecule.

Two years of collaboration among Dr. Michael Owens (UAMS and InterveXion), Dr. Brooks Gentry (UAMS and InterveXion), Dr. Barry Holtz (InterveXion), and Dr. Ralph Henry (UA Fayetteville and InterveXion) led to the funding of the STTR grant. The STTR process provided InterveXion’s scale-up plan and clinical approach with a detailed peer review by an excellent outside panel as part of its award process.

InterveXion has also been awarded an ARRA (American Recovery and Reinvestment Act) grant to accelerate the development and commercialization of the Meth-mAb product. This will focus another approximately $4.0 million dollars on the manufacturing scale-up and preparation materials to support the company’s meth-mAb clinical trials.
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The Disease
The company is developing monoclonal antibodies for Methamphetamine (METH) and Phencyclidine (PCP, “Angel Dust”) abuse.

METH use is a significant international medical issue and its societal and economic impact is profound. The long-term cost to an individual, society and the health care system is larger than expected because its use can lead to chronic medical problems, disruption of the family structure and long-term imprisonment. Methamphetamine abuse affects large numbers of people in North America, Central Europe and Japan.

PCP is a dangerous drug of abuse found in all facets of society and which causes significant psychiatric and medical problems.

The use of a monoclonal antibody (mAb) therapy against drug abuse will be a major clinical event, because it will be the first mAb used for the treatment of a brain disease. The resulting shift in the medical paradigm for how we treat chronic stimulant abuse, and how we can protect the brain from other disease processes, could be a major clinical breakthrough. The successful testing and use of our innovative and long lasting medications will provide a solid platform for the use of specifically targeted mAb's as protective therapies.

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Recent statistics taken from the Substance Abuse and Mental Health Services Administration and other sources:

26 million people worldwide used (+)-METH during a 12-month period from 2003-2004. This more than doubles the number estimated to have used heroin or cocaine (Rawson and Condon, 2007).

During 2007, 3 million people in the USA, aged 12 or older, reported using illicit stimulants, with 1.3 million using (+)-METH. Over 2 million people reported using ecstasy ((±)-MDMA; SAMHSA, 2008a).

Over 140,000 people in the USA presented for treatment of stimulant abuse in 2007. This constituted 7.9% of all drug and alcohol treatment admissions, and represented almost twice the number who presented for treatment in 1997 (SAMHSA, 2009).

Approximately 125,000 emergency department visits in the USA were related to stimulant abuse in 2007, which is 7% of all drug-related emergency department visits (SAMHSA, 2008b).
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Facilities
InterveXion Therapeutics occupies offices and laboratories in the new Arkansas Bioventures Building. This new facility is located on the UAMS campus in Little Rock and serves as an incubator for commercialization of translational research from University of Arkansas for Medical Science (UAMS) and other affiliated institutions. The facility includes offices, laboratories and pilot processing facilities. The building designed to support compliant manufacturing of drug substances for clinical trials.

InterveXion Therapeutics LLC
4301 West Markham Street #831
Little Rock, Arkanasas 72205

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