By Lisa Seachrist
WASHINGTON — Titan Pharmaceuticals Inc. said collaborator Novartis AG has moved into the next stage of clinical trials with iloperidone, launching a Phase III study of the novel anti-psychotic drug to treat schizophrenia.
Novartis, of Basel, Switzerland, licensed iloperidone from Titan in November 1997, and initiated the Phase III program this month. It is the first product from South San Francisco-based Titan to enter Phase III studies.
"Novartis is an excellent partner for us, with experience in the area," said Louis Bucalo, president and CEO of Titan.
Iloperidone became the leading late-stage product in Novartis' schizophrenia program last year, when Novartis obtained the license worldwide — with the exception of Japan — from Titan for $38 million. (See BioWorld Today, Nov. 21, 1997, p. 1.)
The newly initiated Phase III program will include approximately 3,000 patients at 100 centers in 20 countries.
Novartis did not specify a date for completion of the study, but such studies typically take about two years.
Iloperidone, a small molecule drug, is one of a newer generation of anti-psychotic agents that treat both the positive and negative symptoms of schizophrenia.
Patients suffering from the disease have "positive" symptoms that include delusions and hallucinations, as well as "negative" symptoms such as apathy and social withdrawal.
Drug Blocks Serotonin Strongly, Dopamine Weakly
Earlier drugs controlled positive symptoms quite well, but had no effect on negative symptoms, leaving patients unable to interact and function in the world. In addition, many of the older anti-psychotic medications cause uncontrolled muscle movements.
"These side effects can be quite severe," Bucalo said. "They can be a very significant issue regarding whether a patient stays on their medicines."
Like other anti-psychotic medications, iloperidone blocks the brain chemicals serotonin and dopamine. However, iloperidone blocks serotonin strongly and dopamine weakly, whereas earlier anti-psychotics do just the opposite.
Schizophrenics overproduce dopamine in one area of the brain and underproduce it another part. By weakly blocking dopamine, iloperidone may strike a better chemical balance in the brain and avoid the motor-function side effects.
Titan also has moved to Phase II studies with a number of cancer therapeutics in the last few months. CeaVac, an immunotherapeutic cancer vaccine, entered Phase II trials in July, as did TriAb, a vaccine for the treatment of breast cancer.
The company also started a Phase II study of pivanex, a small molecule therapeutic for non-small cell lung cancer. TriGem, a cancer vaccine under development for melanoma, is also being tested as a treatment for psoriasis.
"Our cancer vaccines are being tested in robust, prospectively controlled Phase II studies," Bucalo said, noting that such a design allows the FDA to consider a conditional approval of the drugs if the trials show positive results.
Titan's stock (NASDAQ:TTNP) closed at $3.125, up $0.125. *