Silcaat trial transfer

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Barrowpozbod@... Begin forwarded message:Chiron Corporation and SILCAAT Principal Investigators Agree on Transfer of Trial                   Study to Be Continued Under Scientific Committee's Auspices

Company Also Provides Update on Interim Analysis

EMERYVILLE, Calif., Jan. 14 /PRNewswire-FirstCall/ --

Chiron Corporation (Nasdaq: CHIR) announced today that the company and the

Scientific Committee for SILCAAT, a Phase III study for recombinant human

interleukin-2 (IL-2, aldesleukin) in patients with HIV, have reached an

agreement in principle to transfer the responsibility for the trial to the

investigators. Chiron had announced last October that it was discontinuing the

trial. At the time, the company said that it would work with the Scientific

Committee to maximize the scientific value of the study and that it would

explore a regulatory strategy in the U.S. and Europe. The SILCAAT trial has

continued while Chiron and the Scientific Committee worked on a transition

plan.

"This partnership fulfills our commitment to maximize the scientific value

of SILCAAT by enabling the trial to continue under the auspices of the

Scientific Committee," said Craig Wheeler, President, Chiron

BioPharmaceuticals. "Chiron is committed to leveraging public-private

partnerships to derive clinical benefits from products in our portfolio so

that we can optimally invest our resources to address unmet medical needs."

The Scientific Committee, which is composed of researchers affiliated with

the Hospital Henri Mondor in Paris, the National Institutes of Health, the

University of Minnesota, and other research institutions, is expected to

assume responsibility for the trial early in 2003. The Committee will provide

for the collection and reporting of data and other information related to

SILCAAT, as well as ensuring that SILCAAT will continue to be conducted in

accordance with all applicable regulatory requirements. Chiron will continue

to have access to all data and other information developed in the conduct of

SILCAAT for use in regulatory filings. Administrative oversight of the trial

and sponsorship of the IND is expected to come from the University of

Minnesota and the National Institutes of Health, respectively. Chiron will

provide certain financial and operational support for the study, along with

IL-2. In the event of a positive outcome for the trial, Chiron will continue

to have the right to pursue regulatory submissions for IL-2 in the treatment

of HIV.

The SILCAAT Study and Interim Analysis Update

SILCAAT is the acronym for Chiron's international Phase III Multicenter

Randomized Study of the Biological and Clinical Efficacy of Subcutaneous

Recombinant, Human Interleukin-2 in HIV-infected Patients with Low CD4 Counts

Under Active Antiretroviral Therapy. The trial is an open-label study

designed to compare outcomes of HIV-positive persons with CD4 cell counts

between 50-299/mm3 randomized to receive IL-2 in addition to antiretroviral

therapy with a control group of individuals treated with antiretroviral

therapy alone.

Chiron had expected to complete the SILCAAT trial, including final patient

follow-up, in 2007. Currently 1,975 patients of a target 2,000 subjects are

enrolled in SILCAAT worldwide, with 137 clinical sites in 11 countries. The

primary endpoint is time to first AIDS-defining event or death. Secondary

endpoints include changes (from baseline) in CD4+ cell counts and in plasma

viral load.

To date, Chiron has completed two scheduled interim analyses of data from

the SILCAAT trial, including data from 1,000 patients followed for one year.

Data from the second interim analysis of SILCAAT are consistent with results

previously obtained in Phase II studies, which had shown substantial CD4 count

increases and no negative effect of IL-2 on viral load. The safety of IL-2 is

not a factor in Chiron's decision to discontinue SILCAAT. Data from two

interim analyses of SILCAAT demonstrated that the safety of IL-2 was

consistent with that seen in previous studies. Chiron has determined that

data available from these interim analyses of secondary endpoints do not

support an early approval in the U.S. Chiron remains blinded to primary

endpoint data, which are not expected to be available until the conclusion of

the trial.