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Biotech / Medical : Neurobiological Tech (NTII) -- Ignore unavailable to you. Want to Upgrade?

To: Cacaito who wrote (345)	6/19/1998 8:22:00 AM
From: Dr. John M. de Castro	Read Replies (1) \| Respond to of 1494

This is an impressive Phase I study. Thanks. They report that the hypotension is only apparent at 4 ug, while the clinical benefit was present at 2 ug. At 2 ug there were no instances of hypothension. The whole idea behind a dose escalation study is to identify at what dose problems emerge. So, if you do the study right, you will nearly always find a toxicity problem. You just keep increasing the dose until you do. That does not mean that this is a problem for patients receiving the clinically effective dose. In the case of CRF, there would appear to be a fairly wide window of safety between efficacy and toxicity. In regards to CRF use in brain trauma, NTII has made a strategic decision to focus on peritumoral brain edema. They are not, at present, pursuing the trauma indication. You are right in that the market is smaller for edema. However, the probability of success is much much higher. Trauma is a very tough indication to treat. To see a case in point, take a look at what happened to CNSI's attempts to treat trauma with cerestat. The variance is so high, the disease progression so rapid and unpredictable, and the mortality rate so high that it requires a very large and expensive trial to test for efficacy. In truth NTII can't afford such a trial. The final straw though is the likelihood of success is low. Peritumoral edema, on the other hand, is treatable, has a much lower variance, and the disease progression is normally slow to allow for the assessment of a treatment effect. CRF efficacy can be assessed with a modest trial. I'd gauge the probability of success as high. First the Phase I trial is really quite impressive. Second, CRF was one of only two drugs selected by the clinical oncologists for testing last year. The number of patients is limited, so the oncologists are very selective in regard to what drug they will support a trial on. If my memory serves me correctly, they reviewed about a dozen candidates and CRF was one of the two selected. IMHO NTII has made the right decision on the direction for CRF development. If this trial is successful then CRF will likely be partnered. At which time, the resources for an expensive trauma trial might be available. For now, NTII has focused on the doable and high probability of success indication. This is perfectly appropriate an reasonable for a tiny company like NTII with very limited resources. This is another indication of the acumen of management. Unlike the past where valuable resources were wasted on a Dynorphin A trial, testing a molecule that was too expensive to really be useful for the indication tested, this decision to focus on peritumoral brain edema is very sound, reasonable, and a very good investment of resources. I own NTII stock and have a vested interest in its appreciation. Do your own homework and investigate thoroughly before investing. John de C