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

To: Biomaven who wrote (10049)	1/16/2004 3:25:19 PM
From: JMarcus	Respond to of 52153

Peter, I'll post some notes on Metaphore this weekend. I just posted PCYC's 1/5/04 press release announcing publication of their Phase III Xcytrin study in the Journal of Oncology here: Message 19700204 I am totally new to PCYC, so I appreciate your warning about management's propensity for hiding bad news. The news from the brain metastases trial looks rather convincing to me though. There were 401 patients in the last Phase III trial. The endpoint, neurological progression, was reached at 7.4 mos. for placebo vs. 12 mos. for Xcytrin. That is more than a 4-month difference. Only a 2-month difference will be required for the pivotal trail. The pivotal trial will have 500 patients, which they say is powered at a p-value of .001 to detect a 2 months' difference in time to neurological progression -- the clinical endpoint approved by the FDA in the Special Protocol Assessment. They claim that the new pivotal trial includes some improvements over the measurements made in the last Phase III trial and that they will be including some sicker patients this time around. The CEO also promised good news-flow (hopefully a flow of good news too) throughout the coming year. To quote from his letter to stockholders, they "have launched several Phase 1 and 2 clinical trials evaluating Xcytrin either as a single agent or in combination with antibodies, radiation and/or chemotherapy for many cancers including lung, head and neck, prostate, breast, ovarian, primary brain tumors and lymphomas and leukemias." The company expects to present at AACR in April, at ASCO in June, at ASTRO in October, and at ASH in December. They expect to file another IND in oncology sometime this year. The NCI is paying for a Phase II trial in glioblastoma (always nice to have someone else pay the bills). In the Phase I head and neck cancer study, 8 of 9 patients had a complete response. I don't know what bad news was being omitted from the presentation, but there was a surfeit of good news. Marc

To: Biomaven who wrote (10049)	1/19/2004 5:46:57 PM
From: JMarcus	Respond to of 52153

Peter, here is the promised report on MetaPhore’s presentation at JP Morgan. Background: The company is focused upon low molecular weight compounds that mimic the activity of human enzymes. Its current lead product candidates mimic the function of superoxide dismutase (SOD), a beneficial enzyme that serves an important protective role in removing superoxides from the body. Superoxides are toxic free radicals that can damage cells and tissues. Superoxides are byproducts of the body’s use of oxygen. MetaPhore has two lead candidates in clinical testing: M40403 and M40419. The most exciting clinical indication is for treating pain. Other indications for these products include RA, osteoarthritis, and inflammatory bowel disease (IBD). The Presentation: Alan Dunton, CEO, is a large man - large in body (like a football player, not a sumo wrestler) and in charisma. He is a passionate and effective presenter with a good sense of humor. Before joining MetaPhore, he worked 8 years for J&J. The company has invested about $50M in developing its IP. The patent estate, inherited from Monsanto, is extensive. They have composition of matter patents, with protection through 2020. Alan also boasted about his “experienced management team.” He said the company has a unique ability to synthesize drugable mimetics of human enzymes. The current focus is mimetics of SOD, which is approved for clinical uses as an anti-inflammatory agent. No serious adverse events have been encounters in their Phase 1 or Phase 2 trials. The current focus of the SOD mimetics is pain and inflammation, but the products may also have applications for oncology and CNS disease. Alan thinks the path to FDA approval may be shorter for the pain/inflammation indications. The SOD mimetics have the following unique combination of effects: (1) they significantly inhibit both TNF and IL-1beta, as well as IL2; (2) they show a synergy with Cox 1,2 inhibitors; and (3) they can reduce, prevent, and reverse tolerance to opiates. M40403 appears to reverse cartilage and bone damage caused by arthritis and inflammatory bone disease. It dramatically reduces concentrations of cytokines. M40403 (or “403") is currently in Phase 2 pain studies. They are targeting an NDA filing in 4Q05. The Phase 2 molar extraction pain study included 250 patients. Vicodin was used for rescue relief of pain. At a 20-mg dose of 403, they showed a statistically significant improvement vs. placebo at improving upon the pain-relief response to vicodin. The FDA is interested in 403 as a single-agent treatment to be included with all administrations of opiates, in order to prevent addiction and enhance the effectiveness of the opiates. The initial target for an NDA will be cancer pain. The next target will be post-operative pain. MetaPhore has just started a confirmatory Phase 2 trial of 403 for cancer pain. The trial compares the combination of 403 + morphine with placebo + morphine. The trial is complete, except for reading out the data, which should happen next month. 403 has an almost instantaneous onset of action. It displays no sedating side effects, no abuse potential, and no serious side effects. The pivotal trial will be for an IV formulation, but they already have an IND for an oral formulation to be used to reverse progression of RA. M40484 will initially focus on IBD. They expect to obtain an IND for that indication in 2004. Late in 2004 they hope to obtain an IND for M40588 in the treatment of arthritis and IBD. MetaPhore is developing a line extension of 403 in a pegylated form. That formulation is called M40307. They have or are working on topical formulations. The IP estate is multi-layered. 31 patents have been issued to MetaPhore. MetaPhore has raised $53M. They have $13M left in cash, but their burn rate is ramping up. They expect to complete another financing in either Q1 or Q2 of 2004. Their goals include three new IND filings by early 2005. Marc