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