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

To: Biomaven who wrote (9308)	10/21/2003 9:55:21 AM
From: Biomaven	Respond to of 52153

Looking at these latest results from TELK, I'm regretting that I sold more than half of my position on the way up. Press Release Source: Telik, Inc. Telik Announces Positive Interim Results From Phase 1-2a Clinical Trial Of TELCYTA(TM) (TLK286) in Combination With Carboplatin Tuesday October 21, 7:06 am ET PALO ALTO, Calif., Oct. 21 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) announced positive interim results from its Phase 1-2a clinical trial using escalating doses of TELCYTA(TM) in combination with carboplatin in patients with platinum refractory or resistant ovarian cancer. At the time of interim analysis, eight patients being treated at TELCYTA(TM) (500 mg/m2) and carboplatin (AUC 5 or 6) are evaluable. All patients have platinum refractory or resistant disease. Five of the eight evaluable patients (63%) have objective tumor responses by the RECIST criteria, including one complete response. The overall disease stabilization rate is 88%. TELCYTA(TM) in combination with carboplatin has been well-tolerated in this patient population. The longest duration of treatment with the combination is greater than nine months (9+ cycles). Patient enrollment and dose escalation continues. These data follow the previously reported single agent anti-tumor activity of TELCYTA(TM) confirmed in two Phase 2 trials in ovarian cancer, and represent an important step in the product development process to establish potential use in less advanced cancer patients. Telik intends to present additional results from this clinical trial at the American Association of Cancer Research -- National Cancer Institute -- European Organization for Research and Treatment of Cancer - International Conference on Molecular Targets and Cancer Therapeutics in November 2003. So out of 8 patients you have 1 CR, 4 PRs and 2 stable disease. That's pretty remarkable for this disease population, even if the numbers are small. Peter

To: Biomaven who wrote (9308)	10/21/2003 4:26:23 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Thought I'd talk a bit more about the POZN rejection, because to my mind it speaks to a problem at the FDA. Migraine drugs happen to be an area I know a lot about. Now DHE-45 is an existing drug that was widely used for many years before the onset of the triptans. It's not that widely used any more because it has some drawbacks - it's given by injection, it doesn't always work as quickly as triptans and it causes nausea in some patients. But it does have some advantages - it is usable for people who don't tolerate triptans, it works for some very severe migraines where triptans may not work, and it's effects last a long time (24 hours or more). It is one of the drugs that is sometimes used when people have to be weaned off analgesics and/or triptans because they get rebound headaches (i.e., if they don't take their usual analgesic or triptan fix each day they get a headache). Now all POZN did was somehow reformulate the drug and package it in a pre-filled syringe. I'm not even sure why they needed an NDA rather than trying to sneak it through as a generic. If you look at their trial results, you will see that the drug worked, both at 2 hours and for sustained relief (24 hours). In one of the two trials it showed only improvement not statistical efficacy on a secondary endpoint - nausea (and perhaps photo/phonphobia - I'm not sure on this). This is not particularly surprising, as nausea is one of the drug side-effects in some people. Missing this secondary endpoint is apparently why this drug was given a non-approvable letter. Bottom line is that the drug is different from a triptan - better in some respects and worse in others. Focusing on one secondary endpoint without looking at the big picture is crazy. Now if the company didn't have more drugs coming up at the FDA they would appeal this decision in a shot, and in my view would win easily if they got this in front of an AC panel. Not clear if they are going to do this given they may want to play nice with the FDA given their more significant drug is under review. One issue is how this feeds in to the approval of their other combo drug. This is always tricky because the FDA hates combo drugs. They have statistical efficacy on all endpoints against placebo. But they also have to demonstrate efficacy or advantage against each of the components. Now against the NSAID they don't have statistical superiority. On the other hand they do show statistical efficacy on some secondary endpoints where the NSAID does not show significance. I think that's probably enough for them, but with the FDA acting weird here one never knows. So perhaps part of the sell-off was people worrying about "collateral damage" to their other application. Peter

To: Biomaven who wrote (9308)	10/22/2003 1:22:20 PM
From: tuck	Read Replies (1) \| Respond to of 52153

Peter, MT100 is POZN's other lead candidate, currently under review in Britain, where the MCA has sent something called a "letter of comments." Does anyone here know the implications of this? MT100's market is almost 10x bigger than MT300, the one the FDA slammed. I would think that the announcement of the receipt of this letter, mentioned in the same PR as the FDA action, may have had a lot to do with POZN's haircut. I would have bought, too, but for my uncertainty about that. Thoughts? Cheers, Tuck