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Advaxis Selects inVentiv Health Clinical To Conduct Clinical Trials Of Immunotherapy Candidates

May 29, 2014

PRINCETON, N.J., May 29, 2014 /PRNewswire/ — 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,” said Greg 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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Forward-Looking Statements

inVentiv Health Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause our performance to differ materially. These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. Such factors include, without limitation: the impact of our substantial level of indebtedness on our ability to generate sufficient cash to fulfill our obligations under our existing debt instruments or our ability to incur additional indebtedness; the impact of customer project delays and cancellations and our ability to sufficiently increase our revenues and manage expenses and capital expenditures to permit us to fund our operations; the impact of the consummation of our acquisition of Catalina Health Resource, LLC and any future acquisitions; the impact of any change in our current credit ratings and the ratings of our debt securities on our relationships with customers, vendors and other third parties; the impact of any additional leverage we may incur on our ratings and the ratings of our debt securities; our ability to continue to comply with the covenants and terms of our senior secured credit facilities and to access sufficient capital under our credit agreement or from other sources of debt or equity financing to fund our operations; the impact of any default by any of our credit providers; our ability to accurately forecast costs to be incurred in providing services under fixed price contracts; our ability to accurately forecast insurance claims within our self- insured programs; the potential impact on pharmaceutical manufacturers, including pricing pressures, from healthcare reform initiatives or from changes in the reimbursement policies of third-party payers; our ability to grow our existing client relationships, obtain new clients and cross-sell our services; the potential impact of financial, economic, political and other risks, including interest rate and exchange rate risks, related to conducting business internationally; our ability to successfully operate new lines of business; our ability to manage our infrastructure and resources to support our growth, including through outsourced service providers; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operation, and achieve the resulting synergies; any disruptions, impairments, or malfunctions affecting software as well as excessive costs or delays that may adversely impact our continued investment in and development of software; the potential impact of government regulation on us and on our client base, including the impact of the final HIPAA Privacy Rule on the willingness of pharmaceutical manufacturers to sponsor patient adherence programs; our ability to comply with all applicable laws as well as our ability to successfully adapt to any changes in applicable laws on a timely and cost effective basis; our ability to recruit, motivate and retain qualified personnel; any potential impairment of goodwill or intangible assets; consolidation in the pharmaceutical industry; changes in trends in the healthcare and pharmaceutical industries or in pharmaceutical outsourcing, including initiatives by our clients to perform services we offer internally; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the actual impact of the adoption of certain accounting standards; and our ability to maintain technological advantages in a variety of functional areas, including sales force automation, electronic claims surveillance and patient compliance. Holders of our debt instruments are referred to reports provided to investors from time to time and the offering memoranda provided in connection with the issuance of our notes for further discussion of these risks and other factors.

Advaxis, Inc.

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 at http://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.

SOURCE inVentiv Health Clinical


Source: PR Newswire



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