// Also I believe there are some results due in July or toward the end of summer. Any info would be appreciated. //
First some caveats - I follow the stock reasonably closely, but get most of my information from NTII press releases, 10K & 10Q info, and
this board. If I call the company every 6 months, that's a lot.
As far as I know they only have two clinical trials currently active.
Both deal with Memantine. Dynorphin A has a successful Phase I/II under it's belt, but has no currently active trials. CRF has bombed
for every indication except for cerebral edema. It has had successful
preclinicals (on animals) for cerebral edema but has not yet entered clinicals. (My opinion - if it never does that's OK.) NICOSIM - NTIIs first drug candidate failed and is not being pursued.
Both Memantine trials are in Phase 2.
One, announced December 18,1996, is for Dementia and Neuropathic pain in AIDS patients. It is largely funded by NIH and calls for 120 patients. In order to enter the study the prospective patients must have been diagnosed with AIDS dementia complex and treated with an FDA-approved retroviral for 8 weeks prior to the study. Memantine or placebo will be administered for 16 weeks, followed by 12 weeks of open label treatment with Memantine.
For a while after this trial was announced there was some speculation on this board about the trial. Speculation dealt with potential difficulties in patient accruals and the timeframe the results would be accounced. Some people expressed the opinion that the results would be out sometime in the summer or early fall. John de Castro (again, I think it was him) was of the opinion the results wouldn't be out until January 1998.
IMHO the January figure is much more realistic for several reasons. 1) These things always take longer than we, as investors, want. 2) NIH is funding most of this trial, and they are horrendously slow (especially by our investment-related standards). 3) The protocols call for six months of treatment (28 weeks) and don't take into consideration the time spent accruing patients, compiling reports, and reviewing the results with all interested parties (doctors, NIH, FDA, etc.).
If you are of the opinion that results are due in July and the opinion came from this board, this is probably the trial you are thinking of.
The other Phase 2 trial was announced April 29. It deals with Neuropathic pain in patients caused by diabetes mellitus or post herpetic neuralgia (due to shingles). The protocol calls for 8 weeks of treatment with Memantine or placebo. This is a considerably shorter study than the NIH sponsored trial.
Perhaps you are expecting these results sometime this summer. The protocols take about 2 months. Again you have time issues related to the same issues as with the other trial. Patient accrual should be a little easier and there won't be the NIH "slowdown factor". These trial results MAY come in before the trial on AIDS dementia. I would certainly be interested if anyone has any concrete information about when the results will come out (heck, even speculation would be welcome).
It is possible there are other trials that haven't been mentioned that I don't know about. Sorry for rambling.
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