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Biotech / Medical : Neuroscience -- Ignore unavailable to you. Want to Upgrade?

To: scott_jiminez who wrote (172)	2/1/2001 4:32:13 PM
From: Marty	Respond to of 278

Scott, Thanks for the question. I'm not qualified to answer your question but I will try to get one for you. Give me a little time. I don't know whether or not you will be able to find the answer in the studies Neotherapeutics puts up on their website but the link is neotherapeutics.com They have a section with the published reports there. I know I was overwhelmed that the drug not only survived the GI system and went to the target site and did what it was supposed to do without harmful side effects and an excellent safety profile. Somehow the cascade of events that promotes the growth of a new cell also differentiates it to a neuron and promotes its growth. They have been able to verify that with PET scans at the University of California at Irvine and there is a published report on that study. No reports of the cells going anywhere else or growing into anything else, like feet in the mouth ... which I thought was really funny. Since the stock has been doing so poorly, I needed that. I hope to get you an answer.

To: scott_jiminez who wrote (172)	2/1/2001 10:47:04 PM
From: Marty	Read Replies (1) \| Respond to of 278

Scott - Here is the answer I got from the Company for your question. BTW, it's spelled Neotrofin, with an f and not with a ph. And, incidentally you can call the company with a question on the science and the switchboard operator will get you through to somebody who will answer. Please let me know if, after you read this response, you agree that their press release about increasing stem cells in adult mice is a pretty big deal. Neotrofin is a procainamide-based purine derivative. It has no relationship to norepinephrine. First of all, you raised alot of good questions and there are still many answers we do not know yet. The exact mechanism of action of Neotrofin is not understood yet. What I mean by this is that the receptor or enzyme that the drug targets when it hits a cell is not known. We have looked quite extensively and haven't found it yet. What we do know is that when you treat cells, or an entire animal, with the drug, it triggers an event which induces the selective expression of the neurotrophic growth factors. The drug doesn't turn on the factors in all cells. It triggers something in the cell which tells the cell "make factor X" and induces the cell to do that. In cell in another part of the brain, which needs factor Y to survive or regenerate, that factor is induced. We think that somehow the drug triggers some process which induces the cells to do what they should be doing if they were functioning properly. We have seen that not all areas of the brain produce any one factor. BDNF is produced in some areas and NT-3 in others, for example. There is commonality in neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. In these diseases, brain neurons die, leading to a variety of symptoms depending on the brain region effected. Since Neotrofin has the ability to induce the neurotrophic growth factors selectively and specifically, it has potential for a variety of different diseases where you want to regenerate neurons. In extensive long term toxicity studies we have not seen any of the side effects you see with administration of these growth factors directly via catheters into the brain. We think this is because we are inducing the cells to make the amount of factors which is appropriate, rather than injecting large quantities to allow for a little to actually reach the target cells. Regarding the stem cells, your brain stem cells are constantly proliferating. Things like exercise increase the amount of stem cell proliferation and stress decreases the number. Since Neotrofin increases stem cell proliferation 30-35%, we feel that this will provide benefit and not lead to abnormal cell proliferation. It has been demonstrated that in animals with some type of injury, there is an increase in stem cell proliferation. We feel that Neotrofin may be helping the body accomplish this. At this time, however, there is no evidence that stem cells can be redirected to diseased or injured areas if they were programmed to go somewhere else. I think there are more studies to perform to understand this effect more completely. There are many research groups around the world working to increase the number of brain stem cells to treat disease and injury. It is generally believed that we will be able to harness this mechanism to more effectively treat disease.

To: scott_jiminez who wrote (172)	2/5/2001 3:09:14 PM
From: Marty	Read Replies (1) \| Respond to of 278

NeoTherapeutics to Initiate Pivotal Trial in Alzheimer's Disease For Neotrofin(TM) New higher dose clinical trial to begin in April 2001 Mounting pre-clinical data on drugs action and clinical data gained from dosing studies completed in 2000 lead to enhanced protocol NeoTherapeutics will hold a telephone conference call today (2/5/00) starting at 11:00 A.M. (EST). Alvin J. Glasky, Ph.D., Chairman and Chief Executive Officer; Rajesh Shrotriya, M.D., President; and, Sam Gulko, Senior Vice President Finance and Chief Financial Officer, will discuss issues and answer questions relating to this news release and discuss goals and objectives for 2001. Those wishing to participate should call 888-552-7850 at approximately 10:50 A.M. (EST) . A replay of today's conference call will be available for approximately seven days following the call and can be accessed by dialing 800-642-1687 (reservation # 300784). IRVINE, Calif., Feb. 5 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) announced today that it will initiate a higher dose 12- week study of Neotrofin in Alzheimer's disease. The new study, designed to be ``pivotal'' for registration, will evaluate the effectiveness of higher doses in treating symptoms of Alzheimer's disease. Results from previous studies indicate that daily doses in the higher range were well tolerated, and NeoTherapeutics believes that there is sufficient evidence to expect that the doses to be used will provide enhanced clinical effects. The study is expected to begin in April 2001, and will incorporate 12 weeks of treatment for the primary analysis, followed by 12 weeks of treatment in order to allow patients initially given placebo to receive Neotrofin. Assuming no enrollment delays, this clinical trial should be completed by the end of this year. A second and longer-term pivotal study is planned to commence in the second half of 2001, in which disease course modification will be measured over one year of treatment, while effects on symptom improvement will be measured after 12 weeks of treatment. ``This logical next step for our Neotrofin Alzheimer s clinical program has been based upon a thorough review of all pre-clinical research and clinical data in over 1,100 patients who received this drug in previous clinical trials, particularly the rate and extent of drug absorption in humans as compared to our animal studies,'' stated Rajesh Shrotriya, M.D., President of NeoTherapeutics. ``We have also incorporated the recommendations of our expanded Alzheimer's Clinical Advisory Board and several new consultants, including former high-ranking members of regulatory authorities. The Company s expanded internal medical and scientific staff, including two board- certified neurologists, have developed new clinical protocols to measure and evaluate Neotrofin's efficacy at higher dosage levels in patients with Alzheimer s disease.'' ``A great deal of in-depth analysis, as well as consultation with experts in the field of Alzheimer s disease, has gone into the development of our protocol for the new trial in Alzheimer's disease,'' stated Jacob Huff, M.D., Vice President, Medical Affairs of NeoTherapeutics. ``Neotrofin holds great promise for patients with Alzheimer's disease, both as a symptomatic treatment and as a potential disease course-modifying agent. Our first focus is to get the NDA filed for symptomatic treatment in the shortest timeframe possible. At a later date, if positive results are seen in the second longer-term study designed to show the drug's effectiveness in producing disease-course modification, we plan to ask for extension of the approved treatment indication to include the effect on disease course.'' In a phase 2 clinical study conducted by Steven Potkin, M.D., professor of psychiatry and director of the Brain Imaging Center at the University of California, Irvine, patients treated with 500 and 1000 mg doses of Neotrofin experienced statistically significant improvement in memory, attention and judgement. These behavioral improvements at the higher doses were consistent with changes in brain metabolism seen using Positron Emission Tomography scanning and changes in brain waves measured by electroencephalography. The data from this study were presented in December 2000 at the American College of Neuropsychopharmacology. On January 31, 2001, NeoTherapeutics announced that Neotrofin has significant effects producing increased proliferation of stem cells in the brains of adult mice. A single dose of Neotrofin led to a significant increase in progenitor cells within 24 hours. Regeneration of the nervous system after disease or injury would require re-population by new neurons, and stimulation of brain stem cells may be involved. These data were presented at a recent conference in London. NeoTherapeutics is a biopharmaceutical company focused on the development of small molecule drugs for unmet medical needs for the treatment of important diseases. The Company's most advanced drug, Neotrofin, is currently being developed for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease and spinal cord injury. In animal models of cognitive decline, aging and spinal cord injury, Neotrofin(TM) has been shown to restore neurological function. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics, is engaged in functional genomics research. NeoOncoRx, Inc., a subsidiary of NeoTherapeutics, 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.