ATLANTA, Feb. 13 /PRNewswire/ -- Atlanta-based Tikvah Therapeutics, Inc. has signed a licensing agreement with Therapade Technologies LLC, a drug development company founded by researchers at the Emory University School of Medicine and the College of William and Mary, for worldwide rights to develop and commercialize D-cycloserine and related compounds for the treatment of numerous anxiety-related disorders, including post-traumatic stress disorder, panic disorder, social phobia, obsessive compulsive disorder (OCD), as well as other afflictions exacerbated by anxiety. Tikvah Therapeutics will also explore additional indications for D-cycloserine through its own research and development efforts and the support of further investigator initiated clinical trials.
D-cycloserine, a NMDA receptor partial agonist, is currently approved for other uses, but is expected to be used at a substantially lower dosage in the treatment of anxiety disorders. Drs. Michael Davis and Kerry Ressler of the Emory University School of Medicine and Yerkes National Primate Research Center conducted preclinical studies that demonstrated D-cycloserine helped reduce fears faster, leading to the eventual disappearance, or “extinction,” of the fear(1,2). Based on the results of these preclinical studies, a clinical trial was initiated by the Emory University School of Medicine in which acrophobic patients were given a low dose of D-cycloserine or placebo, administered in conjunction with psychotherapy. The results of the study showed that patients receiving D-cycloserine required an average of 75 percent fewer psychotherapy sessions to reach a defined clinical endpoint of fear reduction compared to the normal course of therapy in other studies. Importantly, the patients treated with D-cycloserine also exhibited increased self-exposure to real-life fearful situations compared to those treated with placebo(3,4).
Additional clinical proof of concept studies have demonstrated the potential benefits of D-cycloserine in treating a variety of anxiety disorders including Social Anxiety Disorder (SAD)(5) and OCD(6), amongst others(7).
“The use of D-cycloserine in treating anxiety disorders, such as phobias, appears to have significant clinical implications -- namely its potential to augment psychotherapy and enhance learning,” said Dr. Harold H. Shlevin, President and CEO of Tikvah Therapeutics, Inc. “The licensing of these compounds fits nicely with Tikvah Therapeutic’s risk reduction and commercialization strategy.”
Tikvah Therapeutics is compiling an investigational new drug application (IND) for D-cycloserine and expects to file the IND with the U.S. Food and Drug Administration in 2007. Related compounds licensed as part of the agreement with Therapade Technologies include a variety of other modulators of the NMDA receptor and various combination products.
“We are pleased to have licensed the D-cycloserine technology to Tikvah Therapeutics,” said Dr. Michael Davis, Co-Founder of Therapade Technologies LLC, Robert W. Woodruff Professor in the Department of Psychiatry and Behavioral Sciences at the Emory University School of Medicine and a scientist in residence at the Yerkes Research Center. “The company’s experienced management team is committed to seeing this compound through clinical development and into the hands of the millions of individuals suffering from anxiety disorders.”
About Tikvah Therapeutics
Tikvah Therapeutics focuses on exploring new uses for already approved pharmaceutical compounds in which new therapeutic uses have been confirmed in multiple, new clinical proof-of-concept studies. This strategy shortens product development timelines -- in some cases by up to seven years -- and substantially decreases the risk associated with the research and development efforts. A second prong of its strategy is to focus on specialized products with multiple stepping-stone indications and strong patent protections for the new uses, thus helping to ensure manageable commercial risk.
Tikvah’s pipeline includes Phase II compounds such as an agent initially targeted to treat neurodegenerative diseases; D-cycloserine and other NMDA receptor agonists for treatment of a variety of anxiety disorders; and multiple other products under consideration.
About Therapade Technologies LLC
Therapade Technologies LLC was formed by Drs. Jason McDevitt, Michael Davis and Kerry Ressler to pursue regulatory approval for the founders’ proprietary therapeutic methods for treating and curing anxiety disorders and other related medical conditions(8).
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*Tikvah Therapeutics, “Bringing Hope to Life” and the above logo design are trademarks of Tikvah Therapeutics, Inc., Atlanta, GA
(1) Walker et al. J Neurosci. 2002 Mar 15;22(6):2343-51- (2) This work was supported by a grant from The National Institutes of Health (Number MH047840) to Dr. Davis. (3) Ressler et al. Arch Gen Psychiatry. 2004 Nov;61(11):1136-44 (4) This work was supported by a venture grant from the Center for Behavioral Neurosciences that is supported by The National Science Foundation. under Agreement No. IBN-9876754 (5) Hofmann et al. Arch Gen Psychiatry. 2006 Mar;63(3):298-304 (6) D-Cycloserine Augmented Exposure Therapy for Obsessive Compulsive Disorder Matt G. Kushner, Suck Won Kim, Christopher Donahue, Paul Thuras, David Adson, Michael Kotlyar, Pharm.D, James McCabe , Jillian Peterson, and Edna B. Foa, Biological Psychiatry (In press) (7) Garakani et al. Mt Sinai J Med. 2006 Nov;73(7):941-9. (8) Dr. Davis and Dr. Ressler are entitled to royalty derived from Therapade Technologies LLC and Tikvah Therapeutics, Inc. from sale of products related to the research described here. Their financial interests could be affected by the outcome of this research. The terms of this arrangement have been reviewed and approved by Emory University in accordance with its conflict of interest policies.
Tikvah Therapeutics, Inc.
CONTACT: Gabrielle Braswell, +1-404-918-0400,gabrielle@gabriellebraswellpr.com, for Tikvah Therapeutics, Inc.
