2007 Key Milestones ONCONASE - Phase IIIb Study Data Imminent
Transcription
2007 Key Milestones ONCONASE - Phase IIIb Study Data Imminent
Key Financial Information *as of April 30, 2007 Fact Sheet Aug. 2007 Overview Alfacell is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE®, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In Three-Dimensional Structure addition to an ongoing Phase IIIb of ONCONASE. study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer (NSCLC) and other solid tumors. 2007 Key Milestones Nasdaq ACEL $2.94 $3.94 $0.73 Shares Outstanding* Market Capitalization* 45.4 M $133 M Management Team Chairman and Chief Executive Officer Kuslima Shogen, Ph.D. Executive Vice President, Chief Financial Officer and Corporate Secretary Lawrence A. Kenyon Board Of Directors Kuslima Shogen, Chairman David Sidransky, M.D., Vice Chairman John P. Brancaccio Stephen K. Carter, M.D. Donald R. Conklin James J. Loughlin, C.P.A. Paul M. Weiss, Ph.D., M.B.A. Alfacell Corporation Scientific Advisory Board Obtain ONCONASE Phase IIIb results Initiate Phase II oncology program Pursue additional partnership opportunities ONCONASE - Phase IIIb Study Data Imminent Phase IIIb results expected mid-2007 in gateway indication of unresectable malignant mesothelioma (UMM) FDA recognized development program Fast Track Status – U.S. Orphan Drug Designation – U.S., E.U., Australia NDA preparation underway Phase I/II program ongoing in oncology Business Strategy Alfacell's proprietary drug discovery program provides for joint design and development of new products with outside partners seeking line extensions and/or improvements of the therapeutic effectiveness of their existing products. Commercial Focus Partnership for ONCONASE in UMM is top priority Investigation of partnership opportunities in indications Expansion of collaborations into new areas Exchange Ticker Share Price* 52 week high* 52 week low* David Sidransky, M.D., Chairman Stephen K. Carter, M.D. K. Ravi Acharya, Ph.D. John J. Costanzi, M.D. Zbigniew Darzynkiewicz, M.D., Ph.D. Michael S. Kinch, Ph.D Jacob V. Maizel, Jr., Ph.D. Susanna Rybak, Ph.D.. Thoracic Cancer Advisory Board Michele Carbone, M.D., Ph.D., Chairman Raja M. Flores, M.D. Harvey I. Pass, M.D. Headquarters Alfacell Corporation 300 Atrium Drive Somerset, NJ 08873 Phone: 732-652-4525 Fax: 732-652-4575 oncology www.alfacell.com Recent News Fact Sheet Aug. 2007 ® ONCONASE is a first-in-class therapeutic based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action. Alfacell’s RNA Technology Unique Enzymes Degrade tRNA Target miRNA Trigger G1 cell cycle arrest and Apoptosis in tumor cells p53-independent apoptosis o • Alfacell and US Pharmacia Announce ONCONASE® Distribution Agreement for Eastern Europe (7/26/2007) • Paper in Cancer Biology & Therapy Confirms In Vitro Cytotoxic Effect of Alfacell’s ONCONASE® (7/23/2007) • In Vitro and In Vivo Data Show Alfacell’s ONCONASE® is Active Against Naïve and Chemoresistant Neuroblastoma Cells (6/27/2007) • Alfacell Announces Third-Quarter Financial Results and Highlights (6/8/2007) • Alfacell and University of Bath Collaborators Identify Structure of Amphinase (5/29/2007) • ONCONASE® has Potential as Chemopreventive Agent in Mesothelioma, Reports WorldRenowned Mesothelioma Researcher at AACR Annual Meeting (4/18/2007) • Preclinical Data Show Alfacell's ONCONASE® Inhibits Tumor Growth of Non-Small Cell Lung Cancer, Breast Cancer Cells (4/16/2007) • Researchers Identify Intracellular Pathway of Alfacell's ONCONASE® (4/05/2007) Intrinsic or extrinsic pathways Promising Drug Candidates Single agent Combination therapy Conjugates Fusion products MECHANISM OF ACTION Recent Conference Presentations • • • C.E. Unterberg, Towbin Emerging Growth Opportunities Conference BIO Business Forum BIO CEO & Investor Conference Contacts Media David Schull or Wendy Lau Russo Partners [email protected] wendy.lau@ russopartnersllc.com (212) 845-4271 Investors Andreas Marathovouniotis Russo Partners [email protected] (212) 845-4253 Investor Information This fact sheet is a summary of more detailed disclosure that can be found in Alfacell Corporation’s filings with the U.S. Securities and Exchange Commission and its press releases. Additional information on investment can be found at www.alfacell.com. Further, this fact sheet contains information that is given as of the date below, and Alfacell Corporation does not undertake any obligation to update any information in this document. Aug. 2007 www.alfacell.com