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Press Release
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Apthera Announces Phase III and Commercial Drug Formulation for NeuVax™
Scottsdale, Arizona – December 9, 2008 – Apthera, Inc., a biotechnology company focused on peptide-based cancer immunotherapy, today announced that it has determined to go forward with a lyophilized form of the E75 peptide component of its NeuVax product. This commercially viable formulation will provide the Company a stable drug product to conduct worldwide Phase III clinical trials and prepare for commercial sales.
The Company has entered into alliances with two international contract manufacturing organizations for Phase III clinical and commercial supply of key components of NeuVax. The first is a supply agreement for the active pharmaceutical ingredient, HER2/neu peptide p369-377 or E75, and the second, an agreement with a global provider of drug formulation development and manufacturing services to the international pharmaceutical industry. Apthera expects to finalize both the scope and role of its existing and secondary manufacturers of the drug substance and drug product in the near future.
Dr. Charles Morgan, President and CEO of Apthera, stated, “Creating a highly stable, lyophilized “off the shelf” peptide formulation allows us to offer patients a product that does not involve the difficult and costly production of individual ‘autologous’ cancer vaccines. This achievement will help realize the commercial potential of this new product in the fight against breast cancer and other malignancies.”
About Apthera
Apthera, Inc. is a privately-held, Arizona-based biotechnology company developing a pipeline of peptide-based immunotherapies for cancers that express HER2/neu, a well-validated and established oncology target. The Company’s lead product, NeuVax, contains the E75 peptide which is one of the rare T-cell peptides that has been documented to elevate or boost pre-existing anti-cancer immunity in cancer patients. High-level immune responses in patients administered NeuVax are consistent with recall responses of T-cells. NeuVax’s initial indication is for early-stage breast cancer patients who don’t qualify for trastuzumab (Herceptin®) therapy. For more information about the Company visit www.apthera.com.
This news release contains forward-looking statements. These statements are not historical facts and are subject to risks and uncertainties which could cause actual results and the timing of certain events to differ materially from those set forth in or implied herein including, without limitation, risks associated with clinical development, regulatory approvals, product commercialization, intellectual property claims litigation and other risks associated with the Company’s proposed activities.
Contact Apthera:
Gail Thurston
Vice President, Corporate Development
(480) 882-8841
gthurston@apthera.com
www.apthera.com
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