PHARMACEUTICAL PROFILES LAUNCHES A NEW EARLY PHASE DEVELOPMENT SERVICE AIMED AT DIAGNOSTIC AND THERAPEUTIC RADIOPHARMACEUTICALS FOR THE NUCLEAR MEDICINE MARKET

Pharmaceutical Profiles - an early phase drug development services company that utilizes sophisticated medical imaging techniques to evaluate pharmaceutical product performance in man - recently launched its biodistribution services with an exhibit at the 49th Annual Society of Nuclear Medicine Meeting in Los Angeles, CA.

Pharmaceutical Profiles - an early phase drug development services company that utilizes sophisticated medical imaging techniques to evaluate pharmaceutical product performance in man - recently launched its biodistribution services with an exhibit at the 49th Annual Society of Nuclear Medicine Meeting in Los Angeles, CA. The company also plans to exhibit at the forthcoming European Association of Nuclear Medicine Congress in Vienna, Austria, to complete the launch in Europe.

Radiopharmaceuticals are used in diagnostic imaging and therapeutic applications in nuclear medicine. There are an increasing number of new radiopharmaceutical products in development, all of which must pass rigorous testing to determine their efficacy and safety. Biodistribution investigations determine the safety and effectiveness of radiopharmaceuticals in Phase I/IIa clinical trials. Pharmaceutical Profiles' biodistribution division is well placed to service this growing market, leveraging off Pharmaceutical Profiles' established experience in the area of gamma scintigraphy. The recent investment in a state-of-the-art dual-headed gamma camera, as well as the hiring of key personnel, has enabled Pharmaceutical Profiles to offer comprehensive biodistribution study services to pharmaceutical companies with radiopharmaceuticals in Phase I/IIa development.

Pharmaceutical Profiles is the first contract research company to offer a tailor-made scientific, clinical and regulatory biodistribution service and it believes there are significant advantages in assessing new diagnostic agents in such a commercial environment.

Recently revised FDA guidelines have sought to clarify and expand the scope of early phase clinical trials required for such products. These regulations place increased emphasis on the pharmacological and toxicological response of both the radionuclide and the ligand (carrier) components, in addition to the evaluation of the radiation absorbed dose and biodistribution.

"Despite revisions to the FDA regulations in this area, there is much confusion and uncertainty with in the design of early phase clinical trials", explained Dr. Dennis Heller, Vice-President, biodistribution Business Development for Pharmaceutical Profiles, "Our experience over several years in assisting clients with the optimization of clinical trial objectives, to address the concerns set forth by regulatory agencies such as the FDA, sets us apart from other centers" explained Dr. Heller. "For many companies this experience is often the key to initiating a successful clinical program."

In recent years, the trend has been for the design of very comprehensive Phase I/IIa studies with multiple objectives to address safety, pharmacokinetics and biodistribution. Historical providers such as academic research centers and nuclear medicine departments within hospitals will be increasingly less able to manage these types of studies due to their complexity and demand for dedicated resources.
   
"Pharmaceutical Profiles has the advantage over traditional providers of the unlimited availability of imaging equipment and dedicated staff trained in the conduct of clinical research studies of this type within a commercial environment", added Dr. Heller, "These services and facilities have been established by Pharmaceutical Profiles to provide rapid initiation and completion of comprehensive biodistribution studies expediting the early clinical development of radiopharmaceuticals".

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For further information, please contact:

UK:   Paul Clewlow      +44 115 974 9000   paul.clewlow@pharmprofiles.co.uk
   Richard Gee      +44 115 950 8399   enquiries@gbcspr.com

US:   Dennis Heller      +1 609 951 2205   dennis.heller@pharmprofiles.co.uk

Or   www.pharmprofiles.co.uk

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