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

To: tuck who wrote (70)	3/11/2003 5:35:13 PM
From: tuck	Read Replies (1) \| Respond to of 139

PGNX retesting the bottom these days. Wondering if the market is upset that MNTX results aren't out yet. Or maybe it's these PRO 542 results, which look OK to me. But the tankage started exactly when this was released . . . >>BOSTON--(BUSINESS WIRE)--Feb. 11, 2003-- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX - News) reported encouraging new findings from a phase-2 clinical trial of its investigational drug, PRO 542, for treatment of human immunodeficiency virus (HIV) infection. Progenics' scientists found that the magnitude of viral load reductions observed in a previously completed clinical trial were correlated strongly with viral susceptibility to PRO 542 prior to drug treatment, as measured by the PhenoSense(TM) HIV Entry assay from ViroLogic, Inc. (Nasdaq: VLGC - News). The Company believes that viral-resistance testing may identify patients who will derive the greatest benefit from therapy with HIV entry inhibitors. In addition, patient viruses collected six weeks after treatment initiation showed no evidence of having developed resistance to PRO 542. The findings were presented at the 10th Conference on Retroviruses and Opportunistic Infections in Boston. PRO 542 belongs to a new class of drugs, viral-entry inhibitors, which are intended to prevent HIV from entering and infecting cells. Unlike currently approved therapies that block viral replication in cells already infected with HIV, PRO 542 is an antibody-like molecule that is designed to target and neutralize the virus in the bloodstream. Because of its novel mechanism of action, PRO 542 has the potential to be broadly active against viruses that have acquired resistance to existing classes of antiretroviral therapies. Late last year, the Company reported that, in a phase-2 clinical trial, single doses of PRO 542 reduced concentrations of HIV in the blood by 60% to 80% in a target population of highly treatment-experienced patients. The viral-load reductions were sustained throughout the six-week follow-up period, and no serious side effects were observed. Now, new laboratory studies performed in association with this trial revealed that clinical activity (cumulative viral-load reduction) was highly correlated (r = 0.97 and p = 0.0077) to in vitro viral susceptibility to PRO 542 as measured via the PhenoSense HIV Entry assay. The PhenoSense Entry assay was also used to compare the susceptibility of patients' viruses to PRO 542 before and after therapy. No significant change in PRO 542 sensitivity was observed for viruses collected from patients at the end of the six-week study period, during which time most patients continued to have reduced viral loads. This clinical finding supports previous laboratory studies and suggests that viral resistance to PRO 542 does not readily develop in man. "We are currently testing PRO 542 in multi-dose phase-2 clinical studies as therapy for HIV-infected individuals who are no longer responding to available antiretroviral therapies," explained William C. Olson, Ph.D., Progenics' Vice President of Research and Development. "The strong correlation between measurements of viral sensitivity and the magnitude of viral-load reductions, support the use of the PhenoSense assay in future clinical studies as a means of identifying and selecting those treatment-experienced patients who might benefit most from PRO 542 therapy." Progenics is also developing PRO 140, a second HIV entry inhibitor PRO 140 is a humanized monoclonal antibody that is designed to block HIV entry by binding to a portion of the CCR5 receptor that the virus uses to infect cells. PRO 140 has been shown to inhibit the entry of multiple strains of HIV into immune system cells, in vitro. In addition, it has demonstrated the unique ability to block HIV entry via CCR5, while leaving the normal function of this receptor unaffected. Preclinical testing and manufacturing scale-up are expected to be completed in the coming months, with the Investigational New Drug Application scheduled to be filed thereafter. << snip Cheers, Tuck