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

To: Dr. John M. de Castro who wrote (389)	1/13/1998 11:19:00 PM
From: John McCarthy	Respond to of 449

John - Cannot thank you enough. I mean it. Good god. The dreaded "E" word - again! I got killed at the OK Depo corral. I don't read well because I am more accustomed to reading table type data. During the DEPO saga I created the table below. This weekend (I'm tired) I will read the NXCO press release and see if I can fit their numbers into this format. I want to "catch" the difference between the total universe of "intended to treat" versus "evaluable". Regards, John ============================================================= IGNORE ALL NUMBER BELOW - THEY HAVE NOTHING TO DO WITH NXCO ============================================================= JUST THE FORMAT IS IMPORTANT ============================================================= ------------------------------------------------------------------- Part 1 - Reconcile past ODAC meeting ------------------------------------------------------------------- ODAC VIEW OF DATA ------------------------------- ------- ------- ------ DepoCyt Cytar- Metho- abine trexate Total ------------------------------- ------- ------- ------ A A Total Population 31 30 61 B B Not Evaluable 0 0 0 ------- ------- ------ C A - B Adj. Population 31 30 61 ------- ------- ------ D D Responders 8 6 14 E E Responders Not Evaluable 0 0 0 ------- ------- ------ F D - E Adj. Responders 8 6 14 ------- ------- ------ G F/C % Responding 26 20 -- ======= ======= ====== DEPO MANAGEMENT VIEW OF DATA ------------------------------- ------- ------- ------ DepoCyt Cytar- Metho- abine trexate Total ------------------------------- ------- ------- ------ A A Total Population 31 30 61 B B Not Evaluable 7 1 8 ------- ------- ------ C A - B Adj. Population 24 29 53 ------- ------- ------ D D Responders 8 6 14 E E Responders Not Evaluable 0 1 1 ------- ------- ------ F D - E Adj. Responders 8 5 13 ------- ------- ------ G F/C % Responding 33 17 -- ======= ======= ======

To: Dr. John M. de Castro who wrote (389)	1/14/1998 10:06:00 AM
From: NeuroInvestment	Read Replies (1) \| Respond to of 449

Three notes: 1) Technically, ziconotide is a specific calcium channel blocker, operating at a slightly different location than competitive NMDA antagonists. The neuropsychiatric side effects sometimes seen in the latter class of drugs (hallucinations, catatonia) have not to my knowledge been associated with ziconotide.The side effects of the two classes can be quite different, for example the late and lamented NMDA antagonist Cerestat caused mild hypertension. 2) The hypotensive crises have been associated with IV use of ziconotide in head trauma, where the dose is several thousandfold greater (70mg per day) as opposed to the .3-300 micrograms qd used intrathecally in pain. It is true that blood brain barrier absorption cuts down greatly on the amount of drug actually reaching the brain in IV administration, thus the ultimate difference in brain levels reached is much less (and perhaps those patients reporting dizziness are having some mild hypotension). However the hypotension issue will be irrelevant to malignant pain, and I do not expect it to be critical for ambulatory neuropathic pain patients, though there it will likely have to be monitored. 3) With ample headroom in sample size, and a reasonably robust treatment effect, analyzing the overall population of 'intent to treat' patients is not likely to significantly shake the efficacy findings. This is not a borderline level of magnitude where 30-40 patients would be expected to make a crucial difference. NeuroInvestment