Thanks, Nikita, I'll copy the release below this for anyone who may be interested. It seems to me that what may be the significant new information here is that the drug is biologically active in an area of the brain having to do with emotions and that hasn't been mentioned before. As I haven't any education in this field it is hard for me to follow all of it but as far as I can tell, it all positive developments. Is that your take as well?
I am reading this brand new book out about the history of Alzheimer's research that is helping. You biotechies would get more out of it than me. It's called "Decoding Darkness" by R. Tanzi.
Statistically Significant Improvement In Behavioral Symptoms IRVINE, Calif., Oct. 26 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT, NEOTW) announced today that patients who received Neotrofin(TM) ('AIT-082', leteprinim potassium) once daily, orally, in a berry flavored suspension, in a multi-site, global Phase 2 study showed a statistically significant improvement in the Neuropsychiatric Inventory (NPI) rating scale over the course of 90 days of treatment. NPI is a recognized test that measures behavioral symptoms such as psychosis, aggression and hallucinations. In Alzheimer's disease deficits in the areas of cognition, progressive worsening of memory, and other clinical features such as emotional and behavioral disturbances cause great distress in caregivers, family and friends. Neotrofin(TM) appears to significantly reduce such symptoms, thus minimizing the burden of care on family and friends and enhancing the quality of life. Preliminary results from this study were presented in July at the World Alzheimer's Congress 2000 and the current complete analysis of the data extends and confirms the previously reported results. The study's results showed that those patients who were suffering from more moderate Alzheimer's disease and who received the 500 mg dose level of Neotrofin(TM) improved an average 1.5 points from baseline on the Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog) after only 90 days of treatment. The study also demonstrated that Neotrofin(TM) is safe and well-tolerated in elderly patients with Alzheimer's disease. Of the 431 patients enrolled in the study, 389 or 90 percent, completed their dosing through day 90. The high percentage of patients completing the study is supportive of the drug's tolerability and safety. The frequency of reported side effects, called adverse events, was similar between patients receiving Neotrofin(TM) and those receiving placebo. "For a preliminary study that was designed primarily to evaluate only dose-range and drug safety, these results encourage us to develop Neotrofin(TM) as the first drug to potentially cause disease course modification," said Rajesh Shrotriya, M.D., NeoTherapeutics' President. "Consequently, clinical development of Neotrofin(TM) for the treatment of Alzheimer's disease will continue on its aggressive pace, focused on further exploring the most effective dose, duration of treatment, and patient population." "The results from this initial 90-day Phase 2 clinical trial provide us with a wealth of information regarding the future development of Neotrofin(TM)," added Scott Wieland, Ph.D., NeoTherapeutics' Vice President of Product Development & Regulatory Affairs. "First and foremost is that Neotrofin(TM) is effective in improving the severity of the neuropsychiatric symptoms associated with Alzheimer's disease - behavioral syndromes such as psychosis, aggressive behavior and hallucinations - areas of great concern to caregivers for obvious reasons." "Secondly, Neotrofin(TM) produces a greater beneficial effect at higher doses in those patients with more moderate Alzheimer's disease," continued Dr. Wieland. "Thirdly, we believe that a 90-day clinical trial is not of sufficient duration to observe Neotrofin's maximal effects," added Dr. Wieland. "Longer trials will be required to determine whether Neotrofin(TM) simply provides symptomatic relief, or causes true modification of the course of the disease - an effect that has not been demonstrated by any currently available drug. Disease course modification is congruent with our on-going pre-clinical studies demonstrating Neotrofin's nerve regenerating properties." NeoTherapeutics' is a leader in the field of nerve regeneration therapy. The Company's most advanced drug candidate, Neotrofin(TM), is currently being developed for Alzheimer's disease as its first indication, and is being tested in placebo controlled clinical studies involving some 2,000 patients worldwide. In animal models of cognitive decline, aging and spinal cord injury, Neotrofin(TM) has been shown to restore function. Recent data also has demonstrated the ability of Neotrofin to reduce beta-amyloid accumulation in cell culture. 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 (SEC). SOURCE NeoTherapeutics, Inc. -0- 10/26/2000 /CONTACT: Media Relations: Jon Siegal of Ronald Trahan Associates ("RTA"), Inc., 508-647-9782 or Investor Relations: Carol Gruetter of NeoTherapeutics, Inc., 949-788-6700, cgruetter@neotherapeutics.com/ /Web site: neotherapeutics.com (NEOT NEOTW) CO: NeoTherapeutics, Inc. ST: California IN: MTC SU: |
