A new hope for pain

ATLANTA—Tikvah Therapeutics Inc. last month entered into anexclusive licensing agreement with Apkarian Technologies LLC for patents andpatent applications involving certain agonists of specific sites of the NMDAreceptor. These newly-acquired rights provide Tikvah with claims encompassingthe treatment of chronic pain and pain-related indications with glycinereceptor agonists as a monotherapy or in combination therapy with certain otheragents.

Tikvah Therapeutics focuses on identifying new therapeuticuses for already approved pharmaceutical compounds where such uses have beenconfirmed in multiple, new clinical proof-of-concept studies. This strategyshortens product development timelines—i n some cases by up to seven years—andsubstantially decreases the risk associated with the research and developmentefforts, says Dr. Harold Shlevin, company president and CEO.

For example, though his company has been in business forjust over a year, he believes that its sodium phenylbutyrate drug for treatmentof spinal muscular atrophy could be at the NDA stage by mid-2009 and on themarket a year later. SMA is a genetically determined wasting disease—about ascommon as cystic fibrosis—that affects motor neurons and in its worst forms canlead to the death of infants before their second birthday.

The agreement with Dr. A. Vania Apkarian is based on thesame strategy. His work has suggested that treatment with certain classes ofglycine receptor agonists, alone or in combination with other agents, can beused to treat chronic pain as well as modify the structural brain changes thatoccur under conditions of chronic pain. "We are delighted that TikvahTherapeutics sees the potential benefit of our technologies for the treatmentof chronic pain," said Dr. Apkarian, president of Apkarian Technologies andprofessor of physiology, The Feinberg School of Medicine, Northwestern University. More than one quarterof Americans age 20 years and older—or, an estimated 76.5 millionAmericans—report that they have had a problem with pain that persisted for morethan 24-hours.

Concurrent with its formation in 2006, Tikvah signed alicensing agreement with Therapade Technologies LLC, to develop andcommercialize D-cycloserine and related compounds for the treatment of numerousanxiety-related disorders, including acrophobia, post-traumatic stressdisorder, panic disorder, social phobia, and obsessive compulsive disorder.

D-cycloserine, a NMDA receptor partial agonist, is currentlyapproved for other uses, but is expected to be used at a substantially lowerdosage in the treatment of anxiety disorders. Preclinical studies havedemonstrated that D-cycloserine helped reduce fears faster, leading to theeventual disappearance, or "extinction," of the fear. The results of the studyalso showed that patients receiving D-cycloserine required an average of 75percent fewer psychotherapy sessions to reach a defined clinical endpoint offear reduction compared to the normal course of therapy in other studies."Theuse of D-cycloserine in treating anxiety disorders, such as phobias, appears tohave significant clinical implications—namely its potential to augmentpsychotherapy and enhance learning," says Dr. Shlevin. "The licensing of thesecompounds fits nicely with Tikvah Therapeutic's risk reduction andcommercialization strategy."