BioWorld International Correspondent
LONDON - CeNeS Pharmaceuticals plc said its lead product, morphine-6-glucuronide (M6G), is ready to enter Phase III trials, as it announced additional positive results from its recent Phase II trials.
However, it is unclear how the Phase III trials will be funded, as CeNeS' partner, Elan Pharmaceuticals Corp., of Dublin, Ireland, wants to "simplify" their joint venture, and is not expected to fund future trials.
Neil Clark, CeNeS' chief operating officer, told BioWorld International, "We've said 2005 was the likely launch date and that still holds. However, we have uncertainty with Elan, because they are looking to cut back funding of joint ventures, and it is not clear at the moment what will be the upshot of this."
Clark noted that Elan is a shareholder of CeNeS and a has a director on the board, and that the aim of the current discussions is to manage Elan's reduced commitment. "We have a good relationship with them, but things have changed."
CeNeS, of Cambridge, has been given a free hand to look for a new partner. The company has not done so thus far, but Clark said, "People are knocking on the door. On our own we do not have the money, but I think we will be in Phase III next year."
M6G is a metabolite of morphine. The aim of the Phase II trial, in 68 patients having hip replacement surgery, was to show the compound has comparable analgesic effects, but with a better side-effect profile, than morphine. Patients receiving M6G had equivalent pain relief, but lower incidences of nausea and retching/vomiting. They also self-administered lower doses of morphine after the initial doses of M6G.
Phase III efficacy studies are now being planned and a pivotal dose-ranging, placebo-controlled study is scheduled to commence in early 2003 in patients undergoing knee replacement surgery. That will be followed by a second Phase III trial comparing M6G with morphine in treating post-operative pain following gastrointestinal and gynecological surgery.
CeNeS also announced a licensing deal with Acorda Therapeutics Inc., of Hawthorne, N.Y., for its recombinant glial growth factor (GGF2) in the treatment of multiple sclerosis. CeNeS will receive $500,000 up front, followed by clinical milestones of up to $12.5 million, plus royalties on any product sales.
GGF2 is involved in controlling the cells that form and maintain the myelin sheath insulating nerve axons. Those cells are thought to be involved early on in the demyelination of nerve fibers in MS. The protein also was implicated in schizophrenia by the discovery in March this year that the neuregulin-1 gene, which codes for GGF2, is associated with schizophrenia.
Acorda has full rights to develop GGF2, which has almost completed preclinical studies, in all indications. Commenting on the deal, Clark said, "Acorda is a good home [for GGF2]. The $500,000 is useful, but it doesn't pay for the Phase III of M6G."