NeoTherapeutics Begins Pivotal Alzheimer's Disease Clinical Study
Enrollment opens for a 12-week study of Neotrofin(TM) in approximately 500 patients with Alzheimer's disease
Results from the high dose efficacy study expected in less than one year
IRVINE, Calif., April 10 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT, NEOTW) announced today that enrollment has opened for a pivotal study of its lead drug Neotrofin in patients with mild to moderate Alzheimer's disease. Approximately 500 patients at over 50 clinical sites throughout the United States are expected to enroll in the study and the Company expects to complete the enrollment process within six months. Assuming no enrollment delays, all patients should complete the primary analysis period by the end of this year. Results from the study are expected to be available by the first quarter of 2002.
The new study, designed to be "pivotal'' for FDA consideration, will evaluate the effectiveness of higher doses of Neotrofin in treating symptoms of Alzheimer's disease. During a 12-week "primary'' analysis period, patients will initially receive 500 mg of Neotrofin or placebo twice a day for one week, and then the dose will be increased to 1000 mg twice a day. The dose may then be maintained at 1000 mg or decreased to 500 mg twice a day, based on tolerability, and the optimal dose will be continued for the remainder of the first 12 weeks. This will be followed by 12-weeks of "extended'' treatment in order to allow patients initially given placebo to receive Neotrofin. The primary efficacy measures for the trial will be the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), which measures cognition and memory, and the Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change (ADCS-CGIC) which measures changes in behavior. Secondary efficacy measures include the Neuropsychiatric Inventory (NPI) and the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).
"Neotrofin holds great promise for patients with Alzheimer's disease, both as a symptomatic treatment and as a potential disease-course modifying agent,'' stated neurologist F. Jacob Huff, M.D., Vice President of Medical Affairs for NeoTherapeutics. "We have assembled a very capable and experienced team to manage the trial, and we are pleased to have many of the leading clinicians in the Alzheimer's field participating in this important clinical trial.''
"The potential benefits that Neotrofin could provide to patients, and the value it could create for our shareholders is enormous. Our team of experts has designed a clinical study with the help of some of the world's leaders in the field that maximizes our potential for success,'' stated Rajesh C. Shrotriya, President of NeoTherapeutics. "While we have achieved major milestones in broadening our product portfolio and the base of value at NeoTherapeutics over the past six months, Neotrofin, as a treatment for Alzheimer's disease, remains our first priority. We are pleased to begin this important next step in the clinical development of the drug.''
Results from previous studies involving over 1,100 Alzheimer's patients indicate that Neotrofin is well tolerated in single doses as high as 4,000 mg and multiple doses as high as 2,000 mg. The Company believes that there is sufficient evidence to expect that the doses to be used in this study will provide enhanced clinical effects. A second pivotal study is planned to commence in the first quarter of 2002. Assuming favorable results, the plan would be to submit these two studies in a New Drug Application to the FDA.
According to the Alzheimer's Association, four million people in the United States have Alzheimer's disease, and that number is expected to increase to 14 million by the year 2050. Worldwide, it is estimated that 22 million people will develop Alzheimer's disease by the year 2025. Currently one in ten people over 65, and nearly half of people over 85, have Alzheimer's disease.
NeoTherapeutics is a biopharmaceutical company focused on the development of drugs for unmet medical needs. The Company's most advanced drug, Neotrofin(TM), is currently being developed for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease and spinal cord injury. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics, is engaged in functional genomics research. A second subsidiary, NeoOncoRx, Inc., is engaged in the development of anticancer drugs. For additional Company information, visit NeoTherapeutics' web site at www.neotherapeutics.com.
This press release may contain forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
Contacts:
MEDIA RELATIONS
Jon Siegal
Ronald Trahan Associates (RTA) Inc.
(508) 647-9782, ext. 15
INVESTOR RELATIONS
John McManus
NeoTherapeutics, Inc.
(949) 788-6700, ext. 247 |
