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Paper in Cell Cycle Reports Alfacell's ONCONASE(R) Targets siRNA
SOMERSET, N.J., Oct. 9 /PRNewswire-FirstCall/ -- Alfacell Corporation(Nasdaq: ACEL) today announced that a paper published in Cell Cycle (2008;Vol. 7, Issue 20) reports that ONCONASE (ranpirnase) targets small interferingRNA (siRNA), likely within the RNA-induced silencing complex (RISC) of the RNAinterference (RNAi) mechanism.
The paper is the result of research conducted by collaborators at theBrander Cancer Research Institute and Department of Pathology at New YorkMedical College and Alfacell. The study demonstrated that silencing theglyceraldehyde 3-phosphate dehydrogenase (GAPDH) gene (an abundant andubiquitously expressed housekeeping gene) in human lung adenocarcinoma A549cells by siRNA was effectively prevented by ONCONASE. While transfection ofcells with GAPDH siRNA reduced expression of this protein by nearly 70percent, the expression was restored in the cells exposed to ONCONASE for 48or 72 hours. The data thus provide evidence that one of the targets ofONCONASE (ranpirnase) is siRNA.
"This data provide further evidence of the impact of ONCONASE on the RNAimechanism," said Kuslima Shogen, Alfacell's chief executive officer."Furthermore, the data may provide the explanation for the preferentialeffectiveness of ONCONASE toward tumor cells as well as its ability tosensitize cells to other antitumor agents. As seen in our Phase III clinicaltrial results, ONCONASE has demonstrated significant efficacy in patients withmalignant mesothelioma that failed prior chemotherapy."
About ONCONASE(R)
ONCONASE is a first-in-class therapeutic product candidate based onAlfacell's proprietary ribonuclease (RNase) technology. A natural proteinisolated from the leopard frog, ONCONASE has been shown in the laboratory andclinic to target cancer cells while sparing normal cells. ONCONASE triggersapoptosis, the natural death of cells, via multiple molecular mechanisms ofaction.
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 BL&H Co. Ltd.for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of USPharmacia, for Eastern Europe, GENESIS Pharma, S.A. for Southeastern Europe,and Megapharm Ltd. for Israel.
ONCONASE has been granted fast track status and orphan-drug designationfor the treatment of malignant mesothelioma by the FDA. Additionally,ONCONASE has been granted orphan-drug designation in the European Union andAustralia.
About Alfacell Corporation
Alfacell 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. Alfacell has completed Phase IIIclinical trials of ONCONASE in unresectable malignant mesothelioma and, inaddition to ongoing efforts to complete the related rolling New DrugApplication, Alfacell is currently planning for Phase II clinical trials inother oncology indications. For more information, visit www.alfacell.com.
Safe Harbor
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate,""project," "expect" or similar expressions. Forward-looking statements involverisks and uncertainties that could cause actual results to differ materiallyfrom the forward-looking statements. Factors that would cause or contribute tosuch differences include, but are not limited to, uncertainty whether theclinical trial results will allow the company to complete submission of a NewDrug Application and if a New Drug Application submission is completed,uncertainty whether FDA will file or approve such application, uncertaintiesinvolved in transitioning from concept to product, uncertainties involving theability of the company to finance research and development activities,potential challenges to or violations of patents, uncertainties regarding theoutcome of clinical trials or differences of opinion in interpreting theresults of clinical trials, the company's ability to secure necessaryapprovals from regulatory agencies, dependence upon third-party vendors, thecompany's ability to timely regain its compliance with NASDAQ continuedlisting standards and maintain such compliance, and other risks discussed inthe company's periodic filings with the Securities and Exchange Commission. Bymaking these forward-looking statements, the company undertakes no obligationto update these statements for revisions or changes after the date of thisrelease.
Media & Investor Contact: David Schull or Wendy Lau Russo Partners 212-845-4271 david.schull@russopartnersllc.com wendy.lau@russopartnersllc.comSOURCE Alfacell Corporation
"This data provide further evidence of the impact of ONCONASE on the RNAimechanism," said Kuslima Shogen, Alfacell's chief executive officer."Furthermore, the data may provide the explanation for the preferentialeffectiveness of ONCONASE toward tumor cells as well as its ability tosensitize cells to other antitumor agents. As seen in our Phase III clinicaltrial results, ONCONASE has demonstrated significant efficacy in patients withmalignant mesothelioma that failed prior chemotherapy."
About ONCONASE(R)
ONCONASE is a first-in-class therapeutic product candidate based onAlfacell's proprietary ribonuclease (RNase) technology. A natural proteinisolated from the leopard frog, ONCONASE has been shown in the laboratory andclinic to target cancer cells while sparing normal cells. ONCONASE triggersapoptosis, the natural death of cells, via multiple molecular mechanisms ofaction.
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 BL&H Co. Ltd.for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of USPharmacia, for Eastern Europe, GENESIS Pharma, S.A. for Southeastern Europe,and Megapharm Ltd. for Israel.
ONCONASE has been granted fast track status and orphan-drug designationfor the treatment of malignant mesothelioma by the FDA. Additionally,ONCONASE has been granted orphan-drug designation in the European Union andAustralia.
About Alfacell Corporation
Alfacell 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. Alfacell has completed Phase IIIclinical trials of ONCONASE in unresectable malignant mesothelioma and, inaddition to ongoing efforts to complete the related rolling New DrugApplication, Alfacell is currently planning for Phase II clinical trials inother oncology indications. For more information, visit www.alfacell.com.
Safe Harbor
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate,""project," "expect" or similar expressions. Forward-looking statements involverisks and uncertainties that could cause actual results to differ materiallyfrom the forward-looking statements. Factors that would cause or contribute tosuch differences include, but are not limited to, uncertainty whether theclinical trial results will allow the company to complete submission of a NewDrug Application and if a New Drug Application submission is completed,uncertainty whether FDA will file or approve such application, uncertaintiesinvolved in transitioning from concept to product, uncertainties involving theability of the company to finance research and development activities,potential challenges to or violations of patents, uncertainties regarding theoutcome of clinical trials or differences of opinion in interpreting theresults of clinical trials, the company's ability to secure necessaryapprovals from regulatory agencies, dependence upon third-party vendors, thecompany's ability to timely regain its compliance with NASDAQ continuedlisting standards and maintain such compliance, and other risks discussed inthe company's periodic filings with the Securities and Exchange Commission. Bymaking these forward-looking statements, the company undertakes no obligationto update these statements for revisions or changes after the date of thisrelease.
Media & Investor Contact: David Schull or Wendy Lau Russo Partners 212-845-4271 david.schull@russopartnersllc.com wendy.lau@russopartnersllc.comSOURCE Alfacell Corporation
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