Food and Drug Administration (FDA) to discuss the company'splanned submission of the final components of the ONCONASE rolling New DrugApplication (NDA) for the treatment of unresectable malignant mesothelioma(UMM) patients.At the pre-NDA meeting, the FDA provided guidance to thecompany recommending that an additional clinical trial be conducted in UMMpatients that have failed one prior chemotherapy regimen, prior to submittinga NDA.As the company has previously reported, the results of the preliminarystatistical analysis of the data from the confirmatory Phase IIIb clinicaltrial for ONCONASE in patients suffering from UMM did not meet statisticalsignificance for the primary endpoint of survival in UMM.However, astatistically significant improvement in survival was seen in the treatment ofUMM patients who failed one prior chemotherapy regimen, a pre-defined primarydata set for this sub-group of patients in the trial, which represents acurrently unmet medical need.The company's current financial situation does not allow it to pursueadditional clinical trials until other sources of capital are secured. Thecompany will effect a reduction in force on January 30, 2009 and otherwisereduce its operations to the minimum sustainable level required to pursuestrategic alternatives and additional capital. Based upon these actions thecompany expects that its current cash reserves will enable it to maintain itsreduced operations through December 2009. The company intends to continue toexplore strategic alternatives and additional capital. Additionally, thecompany's board of directors has agreed to forgo cash compensation effectiveas of January 1, 2009.About ONCONASE(R)ONCONASE is a first-in-class therapeutic product candidate based on Alfacell'sproprietary ribonuclease (RNase) technology.A natural protein isolated fromthe leopard frog, ONCONASE has been shown in the laboratory and clinic totarget cancer cells while sparing normal cells.
ONCONASE triggers apoptosis,the natural death of cells, via multiple molecular mechanisms of action.Alfacell has licensed the U.S. commercial rights for ONCONASE to StrativaPharmaceuticals, a division of Par Pharmaceutical, Inc.Strategic marketingand distribution agreements for ONCONASE have been secured with Megapharm Ltd.for Israel, BL&H Co Ltd. for Korea, Taiwan and Hong Kong, USP Pharma SpolkaZ.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma,S.A for Southeastern Europe. ONCONASE has been granted fast track status and orphan-drug designation forthe treatment of malignant mesothelioma by the FDA.Additionally, ONCONASEhas been granted orphan-drug designation in the European Union and Australia.About Alfacell CorporationAlfacell Corporation is the first company to advance a biopharmaceuticalproduct candidate that works in a manner similar to RNA interference (RNAi)through late-stage clinical trials.
The product candidate, ONCONASE, is anRNase that overcomes the challenges of targeting RNA for therapeutic purposeswhile enabling the development of a new class of targeted therapies for cancerand other life-threatening diseases.For more information, visit HarborThis press release includes statements that may constitute "forward-looking"statements, usually containing the words "believe," "estimate," "project,""expect" or similar expressions. Forward-looking statements involve risks anduncertainties that could cause actual results to differ materially from theforward-looking statements. The biggest SEC Game of the Week is 1 Florida Gators traveling to Louisiana to face the 4 LSU Tigers. Tim Tebow is still a question mark for being able to play; its a game time decision.3 Alabama travels to Oxford to play the 20 Ole Miss Rebels in a game that will shape the SEC West.Im 38-5 for the season in picking SEC games; so Im holding onto a 88 winning percentage I was dead on with my Auburn upset of Tennessee last week. This week offers a potential upset and a number of SEC teams getting beaten at home.Here are my picks for Saturday:SEC Upset of the Week: Florida vs LSU in Baton Rouge. The odds makers love Florida in this game by somewhere in the neighborhood of seven points.
This is a classic case of how great leadership impacts an organization. With Tim Tebow out, this game changes shape.Tebow is the leader and is the go-to man when the pressure is on He makes the third down plays that keep drives going. Tebow makes so many positive things happen that we tend to give the team credit for success when many times Tebows will power created the victory.Without Tebow, this team will not play as well on either side of the ball. I dont believe Tebow will play for the safety of his long term health.On Saturday night, Tiger Stadium will have 92,400 avid fans rocking the planet.