BioWorld International Correspondent

LONDON - CeNeS Pharmaceuticals plc completed a £6.1 million (US$12.1 million) placement, giving the company sufficient funds to prepare for U.S. Phase III studies of its lead drug, morphine-6-glucuronide (M6G), and to advance other products.

At the same time, the Cambridge, UK-based company took the opportunity to effect a 30:1 consolidation of its shares, which have been trading at slightly less than 4 pence each. Reflecting that, the placing price of the new shares is £1.05 per share.

The new money will enable CeNeS to maintain momentum in planning two U.S. Phase III studies for M6G, as it searches for a partner to bear the cost of carrying them out. Meanwhile, the company is required by the FDA to carry out a Phase I pharmacokinetic study of the product also.

Tony Osborne, financial controller, told BioWorld International that partnership negotiations, though protracted, are going well, with several companies involved in discussions. "The partner may be a worldwide one, or we may have different partners for different markets. But first and foremost, we want a U.S. partner."

The search for a partner is backed up by Phase III European data showing M6G has equivalent anesthetic effects to morphine. Unlike morphine, it is not metabolized by the liver, and as a result, causes fewer side effects, such as respiratory depression and nausea and vomiting.

A shortage of cash has forced CeNeS to go slow on the clinical development of the other products following on from M6G, and the company intends to step up investment in the rest of the portfolio.

With its partner Ergomed AG, of Frankfurt, Germany, CeNeS has drawn up plans for two Phase IIa studies of its second product CNS 5161 in the treatment of cancer and neuropathic pain. Osborne said those plans now can be activated, and the trials will start next month.

Ergomed is the contract research organization (CRO) to which CeNeS has outsourced development of CNS 5161 over several years. A year ago, the two agreed to a cost and revenue-sharing deal under which Ergomed is entitled to a share of revenues in proportion to its total investment. That was the first time the German CRO had signed such a co-development deal.

To date, all the trials of CNS 5161 have used an intravenous formulation, but the new funding will allow CeNeS to reformulate the drug for transdermal delivery. It has in-licensed rights to develop a transdermal patch from Alza Corp., of Mountain View, Calif.

CeNeS intends also to move ahead with a Phase I proof-of-concept study of CNS 7056, a short-acting sedative. Earlier this month, the company granted Japanese rights to this product to Ono Pharmaceuticals Co., Ltd of Osaka, Japan. Financial details were not disclosed, but the deal involves up-front and milestone payments, plus sales royalties.

CNS 7056 acts on GABAA receptors. In preclinical studies it rapidly induced deep sedation, which is maintained during administration and wears off once administration stops. CeNeS plans to file for an IND for a U.S. Phase I study to start in the first half of 2008, while Ono expects to commence the Japanese Phase I in the second quarter of next year.