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Critical Pharmaceuticals Limited Announce Interim Results of CP024 Nasal hGH Phase 1 Program that Show Comparable Bioactivity to Injection


9/6/2011 11:28:34 AM

Nottingham, UK, September 6, 2011 / B3C newswire / - Critical Pharmaceuticals today announces that clinical data from it’s ongoing Phase 1 program on CP024, a nasal formulation of human growth hormone (hGH), has shown that CP024 is able to induce IGF-1 to the same levels as a subcutaneous injection of the marketed product. IGF-1 is the main mediator of hGH activity in the body and a clinically relevant indicator of bioactivity.

Human growth hormone is a leading biological drug for the treatment of growth disorders in adults and children with global sales in excess of $3bn in 2010. Current therapies all require daily injections that are strongly disliked by patients and their carers. CP024 has the potential to transform the delivery of hGH by enabling non-invasive delivery.

The ongoing Phase 1 program on CP024 was to evaluate the bioavailability, bioactivity and safety of two CP024 formulations administered intranasally to healthy volunteers relative to a subcutaneous injection of a marketed hGH product.

Professor Illum, the CEO of Critical Pharmaceuticals, stated “We are very encouraged with the interim results from our Phase 1 program that show for the first time that nasal administration of hGH is able to induce IGF-1 to the same levels as a subcutaneous injection. Importantly, CP024 has also been shown to be well tolerated in repeat nasal toxicological studies and in our first human clinical trial. We look forward to starting a Phase 1b study shortly and continuing the development of CP024 to bring intranasal hGH to patients as an attractive alternative to daily injection”.

CP024 has been developed using Critical Pharmaceuticals proprietary CriticalSorb™ technology, a best in class absorption promoter, and is supported by funding from the Wellcome Trust.

About Critical Pharmaceuticals

Critical Pharmaceuticals is a Nottingham UK-based biotechnology company developing a pipeline of unique biological drug products utilizing its proprietary drug delivery technologies. These technologies enable the development of sustained release injectable depot and nasal delivery of proteins and peptides and small molecular weight drugs. As well as developing it's own pipeline, Critical Pharmaceuticals works in partnership with other pharmaceutical and biotechnology companies to enhance the delivery of their novel drug products.

About the Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.

Contact

Professor Lisbeth Illum

CEO

Critical Pharmaceuticals

Tel: +44 (0)115 882 0100

lisbeth.illum@criticalpharmaceuticals.com


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