SOURCE: PharmaVigilant

PharmaVigilant

February 24, 2010 09:00 ET

Cleveland BioLabs Selects PharmaVigilant for Complex Phase I/II Oncology Study

InSpire and I-Warehouse Solutions Offer Increased Access and Control Over Clinical Trial Data

WESTBOROUGH, MA--(Marketwire - February 24, 2010) - PharmaVigilant, a clinical trial technology provider, was recently selected by Cleveland BioLabs, Inc., to support a Phase I/II oncology study for prevention of mucositis in patients with head and neck cancer undergoing chemoradiotherapy. Cleveland BioLabs (NASDAQ: CBLI), a biotechnology company developing a robust pipeline of drugs for multiple medical and defense applications, chose PharmaVigilant for its innovative InSpire EDC and I-Warehouse solutions, the first commercially available clinical data warehouse in the industry.

By utilizing PharmaVigilant's InSpire and I-Warehouse solutions, Cleveland BioLabs has increased access and visibility to all trial data from not only the Phase I/II oncology study, but also all pre-existing trials conducted with PharmaVigilant. This comprehensive and proactive approach delivers significant benefits and allows Cleveland BioLabs to efficiently work across all sites to conduct its trials, dramatically improving the development process for its ground-breaking compounds.

"As we move from defense applications into compounds for medical uses, we need a technology vendor that gives us access and control over our data, an essential factor when conducting a complex trial such as this," said Michael Kurman, M.D., Chief Medical Officer, Cleveland BioLabs. "Because InSpire and I-Warehouse offer unprecedented visibility and access to data across multiple trials, PharmaVigilant was the obvious choice for us. Having our data-on-demand significantly increases efficiencies within our organization and gives us the ability to focus on bringing new and innovative drugs to market more quickly."

"Our ground-breaking solutions continue to demonstrate considerable results for our clients," said James DeSanti, Founder and CEO, PharmaVigilant. "Cleveland BioLabs has utilized InSpire and I-Warehouse in three previous trials, and they selected our solutions once again to ensure best practices for data collection, management and reporting. Our promise of data-on-demand is unmatched in the industry, and as a result we can provide our customers a significant increase in efficiency and data quality. We look forward to working with Cleveland BioLabs to take this new compound to submission."

PharmaVigilant offers a full suite of clinical trial technology offerings including Electronic Data Capture (EDC), data warehousing, study building, Electronic Trial Master File system (eTMF), Remote Source Document Verification (rSDV), study administration and an automated site payment system. PharmaVigilant focuses on Phase I-IV clinical trials, registries and other post-marketing studies. The technology has supported more than 200,000 patients in 14 countries across North America, Europe, Asia and Australia and continues to expand rapidly.

About PharmaVigilant:
Based in Westborough, Mass., PharmaVigilant is a technology company founded in 2005 to demystify the clinical trial process for biopharmaceutical companies. Its full suite of patient-based technology automates the collection and management clinical trial data and most importantly puts that data in the sponsors' hands when and how they want it. Sponsors rely on PharmaVigilant to ease the regulatory and FDA submission and approval process and ultimately go-to-market more quickly with top quality drugs. For more information, visit www.pharmavigilant.com.

About Cleveland BioLabs, Inc.:
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.

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