Antisense set to restart MS drug trial

Melbourne's Antisense Therapeutics (ASX:ANP) is planning to restart the phase IIa trial of its lead drug candidate for multiple sclerosis ATL1102 before the end of the year, following recommendations from its advisory board.

"We are very pleased to be able to report that we are about to send off our application for the recommencement of our phase IIa trial of ATL1102 in MS patients," said Antisense managing director Mark Diamond. "The advisory board unanimously recommended the continuation of the trial and the board fully supported that decision -- they did suggest additional safety parameters and we have adopted all of them."

The Antisense advisory board determined "that ATL1102 appears to have significant potential as a treatment for relapsing-remitting MS patients, its development as a therapeutic agent should continue in earnest."

In March, Antisense voluntarily halted its Phase IIa trial of ATL1102 in MS patients, in the wake of a decision by Biogen Idec and Elan Corp to halt trials of their MS drug Tysabri after two patients were reported to have developed a specific type of viral infection leading to a rare, deadly disease of the central nervous system, progressive multifocal leukoencephalopathy (PML).

Antisense's drug has a different mechanism to Tysabri, but has the same target. The Melbourne company convened an advisory group of relevant experts to consider the potential development paths for ATL1102 in this disease, in light of safety issues associated with.

It its review, the Antisense advisory board found that "the risk of PML developing in patients exposed to ATL1102 in the proposed 8-week phase IIa dosing clinical trial is considered to be minimal". It recommended stepping up monitoring of trial patients "to further minimise any risk potential that may exist for the development of PML to help gain a better understanding of the drug's safety profile."

An application to restart the phase IIa trial is to be submitted to the Institutional Review Board and the Ethics Committee of the University of Essen, the primary site for the phase IIa trial, before the end of September. Diamond said Antisense hopes to screen and enrol patients before the end of 2005. The company will need to formulate additional ATL1102 compound to complete the trial, and manufacture will begin when regulatory approvals are in place.

Antisense will also need additional funds to complete the trials. "We will wait until we have gone through the approval process before we start on making any plans for capital raising," said Diamond.

The Antisense advisory board is chaired by MS expert Prof Fred Lubin (Mount Sinai School of Medicine, New York), and also includes Prof Jerry Wolinsky (University of Texas Health Science Centre, Houston), Prof Chris Polman (The Free University, Amsterdam), Assoc Prof Igor Koralnik (Harvard Medical School, Boston), Dr Stephen Reingold (formerly vice-president of the US National MS Society), and Dr Michael Gallatin (formerly vice-president and scientific director at ICOS Corp).