On the other hand, new investor may pay bit higher price for TTP stock that it is today close.
After first PIII Iloperidone trial (Zomaril), hospital setting for schizo atack, Novartis is going for broad and *normal* schizo-pts population.
Miljenko
Novartis Announces Launch of Phase III Trial to Evaluate Compound in Schizophrenia
- Patient Recruitment Begins Across US -
EAST HANOVER, N.J., Jan. 15 /PRNewswire/ -- Novartis Pharmaceuticals Corporation announced today the initiation of a Phase III clinical trial in the United States for Zomaril™ (iloperidone), a compound being evaluated for treatment of schizophrenia. The study is the first of several in the Zomaril™ Efficacy/Utility and Safety (ZEUS) program and is known as the ZEUS study (ILP3000). The ZEUS study has recently initiated patient recruitment and aims to enroll a total of 600 patients at 40 sites throughout the United States during the next eight months. When it is fully implemented, the ZEUS program will involve 3,300 patients at 208 sites in 24 countries worldwide.
The ZEUS trial is designed to assess the safety and efficacy of three fixed doses of Zomaril™ in patients with schizoaffective disorder or schizophrenia. A devastating condition which affects nearly one percent of the world's population and 2.7 million Americans, schizophrenia is the most common and disabling of all major mental illnesses. Patients in the ZEUS study will receive free medication and be closely monitored on a regular basis by mental health professionals. To be eligible for participation in the trial, patients must be between the ages of 18 and 65, diagnosed with schizophrenia and exhibiting symptoms of the disease.
''Although there have been significant advances made in the treatment of schizophrenia over the past few years,'' said John Kane, M.D., chairman of psychiatry at Hillside Hospital, ''we still lack an optimal therapeutic agent and 20% to 30% of patients do not respond to the current therapies. Therefore research into new modes of treatment is vital for patients battling this horrible disease.''
Schizophrenia impairs patients' cognitive functions causing positive symptoms such as hallucinations and delusions, and negative symptoms such as blunted affect and social withdrawal. The disease typically strikes in late adolescence, with the onset of gross abnormalities in perception and an inability to feel or express pleasure. The profound incidence of suicide among schizophrenics is a well-documented public health problem.
Commenting on Novartis' role in this program, A.N. Karabelas, CEO, Novartis Pharma AG said, ''By sponsoring this trial, Novartis is honoring its long-standing commitment to development of new compounds that may help patients suffering from schizophrenia to re-establish balance in their lives, regain personal independence and improve their overall quality of life. Zomaril is the leading late-stage product in our development program for schizophrenia.''
Novartis has been a leader in the management of psychotic disorders for several decades. Beginning in the 1950's with the introduction of Mellaril® (thoridazine), to the discovery of the breakthrough drug Clozaril® (clozapine) in the 1970's, the company has set new standards of care for patients with mental illness. The development of Zomaril™ (iloperidone), licensed from Titan Pharmaceuticals, once again demonstrates Novartis' commitment to this patient group. To obtain further information about the ZEUS Study, please contact Clinical Trial Leader Josephine Cucchiaro at 973-781-8155.
Novartis Pharmaceuticals Corporation (U.S.) researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals is an affiliate of the Novartis Group, a world leader in Life Sciences, with core businesses in Healthcare, Agribusiness and Consumer Health (Self-Medication and Nutrition). In 1997, Novartis Group sales were 31.2 billion Swiss francs (U.S. $21.6 billion) and invested more than 3 billion Swiss francs (U.S. $2.5 billion) in research and development. Headquartered in Basel, Switzerland, Novartis employs approximately 86,000 people in more than 100 countries around the world.
SOURCE: Novartis Pharmaceuticals Corporation |
