To: BRAVEHEART who wrote (1 ) 1/30/1999 6:04:00 PM From: BRAVEHEART Respond to of 423
NTII UPDATE: Hi Gang, Nothing in the way of a Global Pharma partnership with NTI & MERZ just yet. NTII just received a 100,000 grant for XERECEPT (TM). "Neurobiological Technologies, Inc. Awarded $100,000 SBIR Grant to Continue Phase II Clinical Trial of XERECEPT(TM) for Brain Swelling Due to Cancer" "The funds will be used to continue patient enrollment and treatment in the company's randomized, double-blind, positive-controlled Phase II clinical trial to evaluate the ability of XERECEPT to control neurological symptoms caused by peritumoral brain edema. In this trial, NTI® is seeking to confirm and extend results of its pilot Phase I/II trial, in which the majority of peritumoral brain edema patients treated with XERECEPT experienced clinical improvement in symptoms such as seizures, muscle weakness, loss of coordination and double vision." "Peritumoral brain edema, or swelling in the brain caused by a tumor, is a serious condition affecting approximately 100,000 patients in the U.S. with brain cancer. In these patients, swelling of brain tissue often impairs neurological functioning more than the tumor itself. Symptoms of peritumoral brain edema may include seizures and lack of coordination, as well as impaired mental faculties." ''These patients are in great need of a safer therapy which will restore neurological function and improve their quality of life. High-dose chronic administration of synthetic corticosteroids, the current standard treatment for this condition, can cause muscle wasting, osteoporosis, vision problems, and psychosis.'' ''These side effects are especially devastating in children with brain tumors,'' continued Dr. Carr. ''Children with brain tumors are the patient population which I believe could be most helped by this potential new therapy. If results from the current Phase II trial of XERECEPT(TM) are positive, I hope that the company will be in a position to pursue the possibility of pediatric use.'' A lot has been said about Memantine and the two P-2 clinicals NTI is conducting as well as the three P-3 trials MERZ is conducting. However one should not overlook XERECEPT's potential. The product certainly targets an indication whereby the current form of treatment has untoward side effects. This suggests the eventual opportunity for rapid market penetration if successful. The reality of XERECEPT is the clinical enrollment is extremely slow because of the nature of the disease and treatment protocall. Hence I don't expect this product to be a value enhancer anytime soon unless NTI were to partner it. It is a significant product advancing in clinicals none the less. UPDATES ON CLINICALS: MERZ should complete it's European P-3 clinicals for Alzhimers related dementia relatively soon. The US P-3 clinical for the same indication is not far behind and it's results should be in sometime soon also. NTI's P-2 clinical for Aids related dementia is projected to end in late spring. I believe that this product is a strong candidate for early FDA consideration. Assuming P-2 results are stellar ( prior clinical results suggest this is plausible ) I can see where the utilization of MERZ clinical P-2 & P-3 data for a similar indication ( dementia ) could provide a strong argument to approach the FDA for early consideration. This would be a very significant development for NTI shareholders. NTI's P-2 clinical for Peripheral Neuropathies is enrolling patients at a faster rate than anticipated. This is good news. Essentially this could shave a significant amount of time off the clinical trial. I would attribute this rapid enrollment to two factors. 1. The fact that there is little in the way of effective treatments available to diabetic patients who suffer from this indication. Just talk briefly with a long term sufferer of diabetic neuropathies to learn of their frustrations as I have in various conversations. 2. Quintiles superior experience with clinical trials associated with Memantine. They also conducted MERZ's three Memantine clinicals which have all successfully advanced into P-3 trials.Message 7069713 PS: It is now my understanding that there are certain grandfather provisions relative to a stock which has been delisted. I am told a stock which is grandfathered in only need to achieve a $1 shareprice to satisfy that requirement to be relisted. Hence NTI's hurdle is a stable cash position. This increases my confidence in NTI's eventual ability at regaining listing status if and when it forms a collaboration partnering Memantine in line with it's advanced level and market potential. BEST WISHES LONE WOLF