http://www.earthtimes.org/articles/show/critical-pharmaceuticals-enter-sustained-release-hgh-arena,561758.shtmlNOTTINGHAM, England, October 1 /PRNewswire/--
Critical Pharmaceuticals, the Nottingham, UK-based speciality pharmaceuticals company,
today announced that the successful completion of preclinical trials of a sustained release
formulation of the synthetic human growth hormone (hGH) somatropin. Trials
demonstrated therapeutic plasma concentrations were achieved over an extended
period of time supporting the development of the product as a once every two
weekly injection. In addition, the efficacy profile using biomarkers was
comparable to current daily formulations.
The new formulation was produced using Critical's patented CriticalMix
delivery technology, which is based on world leading supercritical fluid
expertise. This enables the optimal encapsulation of drugs into injectable
microparticles with superior drug release properties. hGH delivery is a
natural application for this technology, and the company now intends to take
this product forward into Phase 1 clinical trials. This decision coincides
with a recent report by Frost & Sullivan valuing the European market at
$846.4m in 2007, with a compound annual growth rate (CAGR) of 2.4 per cent
from 2007 to 2014. The report also highlighted new delivery methods together
with approval for new indications as keys to success.
According to Chief Business Officer Gareth King, these preclinical
results mark an important milestone for the company: "Over the past few
years, we have concentrated on optimizing our delivery technologies and
ensuring they are transferable from the lab into an industrial setting.
Sustained release hGH is one of three projects we are now developing in areas
of unmet need. There is no doubt that a sustained release version of hGH
would be preferred by patients, particularly paediatric, but there are
naturally concerns over safety and efficacy. We are confident the highly
controlled release rates achieved with our technology will overcome these
concerns. The plan is now to take this product into clinic either by
ourselves or in partnership. We are also in preclinical development with
sustained release Risperidone and, demonstrating the versatility of our
technology platform, a once-daily nasal formulation of hGH."
About Critical Pharmaceuticals
Critical Pharmaceuticals is a Nottingham UK-based biotechnology company
with proprietary drug delivery technologies for the sustained release and
nasal delivery of proteins and peptides and labile or insoluble small
molecules. Critical Pharmaceuticals was founded by Professor Steve Howdle in
2002 based on his world leading research into supercritical fluids. Professor
Howdle noticed that supercritical carbon dioxide was able to liquify certain
polymers, and in a moment of inspiration realised that this could be used to
encapsulate thermally labile or solvent sensitive drugs to create injectable
sustained release products. As well as working in partnership with other
pharmaceutical and biotechnology companies, the company is now developing a
pipeline of reformulated drug candidates for areas of unmet needs including
human growth hormone. For more information visit
http://www.criticalpharmaceuticals.com