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Biotech / Medical : Biotransplant(BTRN) -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (1325)	5/15/2002 10:02:08 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 1475

TD: There is nothing inherently wrong with T cell depletion. We have more T cells that we need, day to day. If one were to selectively deplete a subpopulation aside from antigen-activated cells, that might be "unwanted". If MEDI (BGEN, for LFA3tip) shows that there are no adverse events (infection would be a primary concern), then no sweat.... you discontinue treatment if cell count drops too far. However, if I were a psoriasis patient, I'd prefer to avoid it. And, until proven otherwise, it's a pink flag. >> 1) Would the dosing regimen necessarily be the same for psoriasis as for RA? << I would expect the effective dose for psoriasis to be ballpark the effective dose for other autoimmune diseases. However, the potential magic in 507 is in Dumont et al.-like results (including independent results from MEDI, showing a different mechanism but similar message), not in making people 20% better by depleting 20% of their T cells. That's why it is of interest to determine the minimal amount of antibody that is effective. Again, results from the small i.v. phase IIa did not show a dose response. Approximately 1 mg/recipient was as effective (or more effective!), mean reduction PASI, as higher doses. The number of recipients per treatment group was insufficient, however, to draw conclusions. MEDI had, honestly, done too little too late. They're trying to make up for that now. We'll see if they used a little wisdom this time. >> 2) "If" they actually undertake clinical trials with this new indication, would it not be safe to assume that at least they have some anecdotal evidence that the depletion issue isn't that great? << Yes, but the AC meeting for LFA-3tip will provide light on concern, and MEDI's judgement re. 507 is -- IMO -- pure crap. >> 3) Concerning the start of the retreatment studies, would it not be logical to assume that MEDI had to provide some data to the FDA for them to approve such retreatments and if so, wouldn't an issue of depletion preclude such retreatments? << No. Trials that show T cell depletion are nothing new to the world of biologicals. As long as depletion is not deep and long-lasting, side effects have not been pronounced. For psoriasis, it's a concern. Again, we'll see how much of a concern when we hit the LFA-3tip AC. I'd like to avoid depletion if I were a patient, but it wouldn't stop me from seeking treatment with a LFA-3tip or a 507.

To: Arthur Radley who wrote (1325)	5/21/2002 11:15:00 PM
From: Arthur Radley	Respond to of 1475

Morgan Keegan Update! by: PrintedWords (M/Corner of Third and Main!) 05/21/02 11:11 pm Msg: 1858 of 1858 MK's Buddy Lyons issued an update two weeks ago under the title..."Clearing the Air" Highlights of his update: Siplizumab alive and well. Cash concerns overblown. AlloMune data results encouraging. "Siplizumab has become a recent victim of the investor fear factory. Recently, it came to light that two retreatment trials would be conducted. When this information was divulged, investors were quick to sell position, suggesting that investors were worried about the efficacy and future potential of sip. In fact, being retreated in this case was essentially a follow-up study of patients who had been treated previously. The goal of the retreatment trials is to assess the long-term benefits of sip. by measuring the compound's efficacy in patients who had previously received the compound. From this perspective, this news only serve to support the long-term benefits of using sip. and validate this treatment as an effective therapy for psoriasis patients. Furthermore, speculation regarding the future of MEDI-507 was laid to rest as management of MEDI provided an update on the status and future of the compound. On the conference call, MEDI stated that (1) the 124 patient Phase II study has been closed (2) the 121 patient subcutaneious Phase II trial being conducted in Europe should be completed in Q2:02 and (3) the data from the 420 patient multi-arm study that closed in Q4:01 should be available in Q3:02. Management stated that an "enormous" amount of data would be presented before the end of Q3:02 and that a Phase III trial should begin in Q4:02. ......the summer conference of the Am. Academy of Dermatologists happens July 31-August 4. We are speculating that this would be an appropriate venue to present some of the Phase II data. Additionally, MEDI plans to start two Phase II trials in PA(0ne involving Sip. in combination with methotrexate and one with sulfasalazine). According to a Jan. 02 survey by the National Psoriasis Foundation approx. one million patients suffer from this disease. As for the cash issue, he states they have cash to take them to the first Q of 2003 and that he anticipates an equity offering between May and August. And he finally states..."We reiterate our Outperform rating and 12 month $13.00 target." Sounds good, but one must always remember...an equity offering and what Morgan Keegan does for the big bucks. At least I'm encouraged....