Evolutec, the British biotechnology company which develops novel therapeutic products from parasites, is to begin Phase I and II clinical trials with rEV131, its treatment for allergic and inflammatory diseases, in North America in the next few weeks.
The announcement follows the acceptance of Evolutec's first Investigational New Drug (IND) application by the US Food and Drug Administration (FDA).
rEV131 is manufactured using recombinant technology by Cobra Biomanufacturing and this is the first time that the FDA has accepted a protein product made by Cobra for clinical trials.
Dr David Bloxham, chief executive officer of Evolutec, said: "This is a very significant step for Evolutec, given the importance of theNorth American market and the demanding standards set by the FDA. rEV131 will now enter an accelerated clinical development programme to assess its value in human allergic conjunctivitis, a market worth $1 billion worldwide."
He added that data from single and multiple dose studies at a trials centre in Boston, Massachusetts, US are expected in January 2003.
rEV131 is a lipocalin protein derived from tick salivary glands by recombinant technology. The compound binds histamine with high affinity and specificity and blocks its pharmacological actions, such as those which result in itching.
The companies claim the molecule has a novel mode of action compared with conventional anti-histamines because it inhibits white cell migration, probably through the suppression of H4 receptor mediated histamine responses. In pre-clinical modelsrEV131 demonstrated strong anti-inflammatory action, they said.
Dr Mark Abelson, president of Ophthalmic Research Associates (ORA) in the US, added: "A new drug that is more effective in treating itching and that can block more completely the allergic response would offer advantages over current therapies."
ORA, based in Massachussetts, US, will be conducting the clinical programme for rEV131.