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Apthera and TGen Drug Development Services (TD2) Sign Master Services Agreement

Posted on: Tuesday, 5 August 2008, 06:00 CDT

Apthera, Inc., a Scottsdale, Arizona-based biotechnology company focused on cancer immunotherapy, today announced an alliance with TGen Drug Development Services (TD2) under a Master Services Agreement. TD2 will provide key drug development and regulatory services related to the clinical development of NeuVax(TM), Apthera's lead immunotherapy drug indicated for the adjuvant treatment of early-stage, lymph-node-positive breast cancer that contains the HER2 oncogene. Apthera is currently preparing NeuVax for pivotal international Phase III clinical trials.

"We feel that the extra capacity TD2 provides will help accelerate the development of our lead product, NeuVax, filling in vital, near-term responsibilities for our rapidly growing Company," said Dr. Alton C. Morgan, Apthera's President and Chief Executive Officer.

"The clinical team at TD2 is very excited to support Apthera as it prepares for its pivotal Phase III clinical trial, with the goal to improve outcomes in women who received adjuvant treatment for breast cancer, as advances in this arena are still clearly needed," said Dr. Stephen P. Anthony, Chief Medical Officer of TD2.

About TD2

TGen Drug Development Services (TD2), a wholly owned subsidiary of the Translational Genomics Research Institute (TGen), is located in the Mayo Collaborative Research Building in Scottsdale, Arizona. TD2 provides innovative services for oncology-focused biopharmaceutical companies utilizing a dedicated team of professionals with broad experience and understanding in drug development. TD2 is uniquely positioned to support the need for improved and accelerated development of new chemical entities (NCEs) for life-threatening diseases. TD2 utilizes a unique combination of experience gained through its contract research organization business, and an integrated suite of proprietary and non-proprietary tools, preclinical study execution, regulatory affairs assistance, clinical trial design and management, and drug development experts to successfully move therapeutics towards regulatory approval. TD2 is dedicated to reducing the risks and uncertainty inherent in the drug development process.

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, has shown clinical activity in early-stage breast and prostate cancer. 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.

Source: Business Wire

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