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4301 W. Markham St., #831
Little Rock, AR 72205 USA
phone:501-554-2377
fax:501-686-8501
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| Symbol |
Private |
| Founded |
2004 |
| Employees |
2 |
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| www.intervexion.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| Monoclonal Antibodies to Treat Substance Abuse. |
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| Management |
| R. Barry Holtz, Ph.D., President and Chief Executive Officer (CEO); S. Michael Owens, Ph.D., Chief Scientific Officer (CSO); W. Brooks Gentry, MD, Chief Medical Officer (CMO); Ralph Henry, Ph.D, Vice President of Biopharmaceutics; Gerald A. Damerow, Chief Financial Officer |
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| Keywords |
| pharmaceutical, Immuno therapeutics, monoclonal antibody medications, drug addiction, vaccine, methamphetamine abuse, drug treatment, phencyclidine abuse, immunology, neurology |
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| Description |
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InterveXion is a pharmaceutical company using antibody-based therapies to treat human disease, beginning with substance abuse. Based in Little Rock, AR since 2004, we are a limited liability company with four members, and 2 employees. Ownership is closely held by the company's founders and the University of Arkansas for Medical Sciences (UAMS). Space has been leased in the UAMS BioVentures business accelerator building, where we occupy an office and laboratory. |
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| Products / Services |
Our products are monoclonal antibody (mAb) medications that bind to toxic drugs in the blood stream and restrict transport into the brain, blocking the drug's rewarding effects and reducing damage to the user's health. These medications can be combined with counseling therapy for treatment of addiction or used in the ER to reduce the amount of drug in a patient's brain.
InterveXion will have the first antibodies available for human use to treat the effects of phencyclidine (PCP) and importantly methamphetamine (METH), a major drug of abuse in the US. An active vaccine for METH is also being developed. PCP-mAb will be our first product tested in clinical trials for the initial indication of acute PCP overdose. METH-mAb, a treatment for chronic METH abuse, will follow shortly thereafter.
Additionally, several active vaccine prototypes are currently being studied and showing promising results. The addition of an active vaccine to InterveXion's pipeline adds value by diversifying our ability to treat METH-dependent patients.
With a platform ability to bind specific small molecules, applications in biodefense and prevention of toxicities are obvious.
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| Technology / Differentiation |
InterveXion has developed drug-binding antibodies to treat some of the most addictive drugs in society. We have exclusively licensed critical patents and patent applications from UAMS and have the first option for new intellectual property discovered by UAMS in this field. The first two issued patents cover antibodies for treating METH abuse. Five additional applications, including one international filing, address the use and development of antibody-based therapies for treating METH, amphetamine, and ecstasy (MDMA) abuse, and a chimeric mAb for treating PCP abuse.
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| Market / Customers |
In 2005, over 7,500 patients required emergency treatment for associated PCP use, and METH or AMP was involved in nearly 139,000 emergency department visits. In addition, over 150,000 sought treatment for METH and AMP addiction. Recent trends suggest the numbers have likely increased since the last available data.
Both of InterveXion's mAb therapies will be used mainly in two patient markets: drug overdose and prevention of relapse to addiction. For overdose treatment, customers will mainly be emergency room doctors and the hospitals where patients are treated. Customers for relapse prevention treatment will be primary care physicians, addiction specialists and care givers who encourage abusers to seek treatment.
These antibody therapies will be the first drug-specific medicines for treating the effects of PCP or METH in clinical programs as a part of drug abuse treatment.
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| Competitors / Substitutes / Alternatives |
InterveXion knows of no other groups with mAb therapies for METH or PCP. Many small molecule medications or combinations thereof have shown varying degrees of success, but have not shown broad-based success, or were derailed by side-effects, including addiction. None are FDA approved for treating METH addiction, and no specific medications exist.
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| Strategy |
The company strategy is to prove the safety and efficacy of our mAb medications through FDA-approved clinical trials. After successful pivotal efficacy trials, the company will be positioned for collaborative marketing with a strategic partner. This plan allows InterveXion to stay focused on its management strengths, which are monoclonal antibody medication design, drug development, and clinical trials.
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| Funding |
InterveXion has received a STTR grant from the NIH National Institute on Drug Abuse which will total $3 million over five years. This funding will provide nearly the entire preclinical data set necessary to present to the FDA.
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| Status |
Expected pre-IND meeting with the FDA during Spring 2009 to discuss PCP-mAb clinical safety trial.
In final stages of selecting a candidate METH-mAb for clinical development.
Over the last year, InterveXion focused on defining the final steps in the pathway to the clinic for PCP-mAb. This pathway will be the same for our second antibody medication to treat METH abuse, so the effort invested now will be valuable for both products.
Some of InterveXion's recent accomplishments include the following:
Site visited, audited and selected a Contract Manufacturing Organization (CMO) that is qualified to produce the PCP-mAb medication for human use.
CMO completed the development of a Chinese Hamster Ovary cell line capable of producing extremely high levels of clinical grade PCP-mAb, nearly 2 grams per liter in a bioreactor.
PCP-mAb producing cell line has been banked for long-term storage.
Site visited, audited and selected a Contract Research Organization (CRO) which will conduct our first clinical trial to assess PCP-mAb safety in human volunteers.
Was selected and presented at InvestMidwest Venture Conference (St. Louis, MO; Feb. 2008)
Trademarked "InterveXion Therapeutics" for use with our substance abuse medications
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Additional Information |
| UAMS BioVentures Business Incubator-UAMS BioVentures provides client companies significant development support. |
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