Alizyme plc, of London, presented results of the Phase Ib program of ATL-962, a lipase inhibitor, at the International Congress of Obesity in Sao Paulo, Brazil, last week. The three Phase Ib trials involved 99 volunteers in groups of seven or nine, given one of several doses of ATL-962 or placebo, three times daily with food, for five days. The diet was calorie-controlled, with 30 percent of the calories coming from fat. The drug was safe and well-tolerated, and showed evidence of efficacy as indicated by an increase in excretion of fat. Subjects given ATL-962 excreted similar amounts of fat as nine subjects who were given orlistat, the active ingredient of F. Hoffmann-La Roche's Xenical, the only licensed lipase inhibitor. ATL-962 is in a Phase IIb trial in 340 obese patients.
Cambridge Antibody Technology Group plc, of Melbourn, UK, said CAT-213 completed a single-dose Phase I/II challenge trial in hay fever. Preliminary results showed a significant effect on nasal patency (airflow through the nasal passages) and caused reductions of eosinophils and mast cells, two indicators of an allergic response. The compound, a human anti-eotaxin1 monoclonal antibody, was more effective when administered by nasal aerosol than by intravenous injection. The next stage in the development of CAT-213 will be a challenge study in allergic rhinitis.
IsoTis NV, of Bilthoven, the Netherlands, said its founding CEO, Clemens van Blitterswijk, stepped down to concentrate his expertise on the company's research programs in substitution medicine. IsoTis expects to appoint a new CEO shortly. Until then, CFO Pieter Wolters will act as CEO.
Noxxon Pharma AG, of Berlin, completed a mezzanine financing round of €9.3 million, defying a difficult venture capital climate in Germany. The round was led by Merlin Biosciences, of London and Luxembourg. Other members of the financing consortium included WestLB, Hannover Finanz, DEWB, Berlin Capital Fund, Viscardi, Oppenheim and Peppermint. These investors are already Noxxon's principal financial backers. The company expects the fresh funds to support its growth until the fourth quarter of 2003, when its first drug candidates will be entering clinical testing. Earlier in August, Noxxon moved into new headquarters at the BerlinBiotechPark. In June, the company appointed David Pearson CEO. Pearson had worked for more than 15 years for major pharmaceutical companies.
Oxagen Ltd., of Abingdon, UK, in-licensed rights to three polymorphisms, each of which represents a diagnostic marker for the detection of predisposition to osteoporosis. The company said it has added significant value to the polymorphisms, discovered by Nordic Biosciences A/S, by using its clinical collections to show they are associated with the disease. The development of osteoporosis is influenced by a number of genes and polymorphisms, and Oxagen said the license will help it develop a comprehensive panel of diagnostic markers that will pick up the majority of people in a population at risk of osteoporosis.
Oxford Natural Products Ltd., of Oxford, UK, said ONP-04, a prodrug of tetrahydrocannabinol, an active ingredient of cannabis, successfully completed Phase I trials in the treatment of pain. The company said the compound will enter Phase II in the treatment of post-operative pain and terminal cancer pain. The Phase I trial involving 30 healthy volunteers assessed tolerability and blood levels of the drug, which is administered as a rectal suppository. That avoids degradation in the liver and provides improved bioavailability when compared to the licensed THC product, Marinol. ONP said it intends to find a partner to take ONP-04 through to Phase III and onto the market.
Phytopharm plc, of Godmanchester, UK, announced results of a Phase IIa study of P54, a derivative of the spice tumeric, in the treatment of inflammatory bowel disease. The aim of the 27-patient study was to assess whether treatment with P54 could reduce the dose of steroid required to maintain disease remission in patients with steroid-dependent IBD. There was no difference between P54 and placebo, with a 45 percent reduction in steroid use in both groups. However, all patients with less severe disease (as measured by calprotectin levels, a marker of inflammation) who took P54 were able to withdraw from steroid treatment without disease flare, compared to 44 percent taking placebo. The company said the trial indicates P54 may be of benefit to some IBD patients, and it would announce future development plans shortly.