PRINCETON, N.J. -- inVentiv Health Clinical, a leading global clinical research organization (CRO), and Advaxis, Inc. (NASDAQ: ADXS), a biotechnology company developing cancer immunotherapies, announced today that they have entered into a global master services agreement for the clinical development of certain immunotherapy product candidates in Advaxis's proprietary pipeline.
inVentiv initially will work with Advaxis to develop clinical study protocols and will serve as the CRO on the planned registrational trials that will evaluate the safety and efficacy of Advaxis' lead immunotherapy for cervical cancer, ADXS-HPV. In addition, inVentiv will provide feasibility and study start-up activities for the planned clinical development of ADXS-cHER2 in pediatric osteosarcoma.
inVentiv Clinical was an attractive partner for Advaxis because of its comprehensive, global clinical capabilities that offers medical and operational expertise, flexible services, commercial insight and a shared commitment to patients.
"We are extremely happy to be collaborating with Advaxis in advancing Advaxis's platform of cancer immunotherapies," saidGreg Skalicky, Chief Commercial Officer, inVentiv Health Clinical. "By combining the fully-integrated research and development capabilities of Advaxis with inVentiv's broad clinical development and commercial expertise, we are moving well beyond traditional outsourced services and into the realm of a true strategic partnership."
Under the terms of the agreement inVentiv can provide Advaxis with full CRO services to execute clinical studies for the current Advaxis cancer immunotherapy product candidates including ADXS-HPV for cervical cancer, and other HPV- associated cancer; ADXS-cHER2 for pediatric osteosarcoma and other HER2 over-expressing cancer and ADXS-PSA for prostate cancer. In addition, pending regulatory approval, Advaxis can leverage inVentiv's significant commercialization capabilities in select countries, should it seek to do so.
"After an extensive global review of potential clinical research organizations, we selected the broad-scale inVentiv platform as an important differentiator for our program," said Daniel O'Connor, President and CEO of Advaxis. "This agreement spans clinical development, as well as potential commercial support for our cancer immunotherapy product candidates. As a next-generation CRO, inVentiv is able to work across the full development life cycle of each of our immunotherapy product candidates."
For companies selecting inVentiv Clinical, the company often becomes more than a drug development partner. With the resources from across inVentiv Health, drug developers can move more efficiently from clinic to marketplaces as a true strategic ally.
About inVentiv Health Clinical
inVentiv Health Clinical is a next generation CRO. We take a patient-centric approach and apply smarter, fresher thinking to go well beyond traditional outsourced services. We are a leading provider of global drug development services to the biopharmaceutical industry, offering therapeutically specialized capabilities for phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. As part of inVentiv Health, we are the only company in the world that can both develop and fully commercialize products for the life sciences industry. Learn how our clinical, commercial and consulting services support the entire product lifecycle. www.inventivhealthclinical.com
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary platform that is being investigated for redirecting the immune system to kill cancer. The Advaxis technology, using bioengineered live attenuated bacteria, is the only cancer immunotherapy shown to actively suppress Tregs and MSDCs, components in the cancer microenvironment that are believed to contribute to tumor growth and protect it from immunologic attack. Advaxis's lead immunotherapy candidate, ADXS-HPV, is being investigated for targeting human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis Orphan Drug status for each of these three indications. Advaxis plans to initiate a registrational clinical program for cervical cancer in 2014 and has established licensing partners in India and Asia for commercialization in those regions.
Advaxis is also developing, ADXS-cHER2, to target the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and animal-health, and interim findings in an ongoing clinical study in canine osteosarcoma, an excellent model for human bone cancer, have shown clinical benefits. Further confirmatory studies are planned. Advaxis is pursuing a clinical program in pediatric osteosarcoma and has licensed ADXS-cHER2 and three other non-specified immunotherapy constructs to a major animal-health company.
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This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis' ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis' proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapy candidates can redirect the immune response to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2013, which is available athttp://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.