Marillion Pharmaceuticals Initiates Clinical Development of Novel Anticancer Drug



    Marillion Pharmaceuticals, Inc., a privately-held
    development-stage pharmaceutical company focused on novel therapeutics
    for the treatment of cancer, inflammatory and autoimmune diseases,
    announced today that its investigational new drug application (IND)
    has been cleared by the FDA. Marillion is now able to proceed with its
    planned Phase 1 human clinical trial for the company's lead product
    candidate, MN-201, an orally administered vitamin D5 analog for the
    treatment of cancer.

    The Phase I trial will be an open-label, dose-escalation study to
    evaluate the safety and pharmacology of MN-201 in patients with
    advanced tumors in various cancers. The protocol for the clinical
    trial is currently before institutional review boards (IRBs) at the
    sites selected for the trial and clinical supplies are being prepared.

    "MN-201 is the first synthetic vitamin D5 receptor ligand (VDRL)
    to be advanced into clinical trials for a variety of cancers including
    breast, prostate and colon cancers," said Zahed Subhan, Ph.D, chief
    executive officer of Marillion Pharmaceuticals. "Based on a novel
    mechanism of action, MN-201 could have utility as both a monotherapy
    in the treatment of various malignancies and for use in combination
    with other chemotherapeutic agents where synergistic benefits may be
    possible," added Dr. Subhan.

    In preclinical studies, MN-201 demonstrated broad anti-tumor
    activity in cancer cells. In animal models, oral administration of
    MN-201 also resulted in anti-tumor activity including tumor regression
    in xenograft models of major solid tumor types. In contrast to
    treatment with other vitamin D(3) analogs and the naturally occurring
    vitamin D hormone, calcitriol, favorable anticancer effects with
    MN-201 were observed in the absence of significantly raised calcium
    levels.

    About Marillion Pharmaceuticals

    Marillion Pharmaceuticals is an emerging pharmaceuticals company
    dedicated to the development and commercialization of novel
    therapeutics for the treatment of cancers, inflammatory and autoimmune
    diseases. Marillion's product pipeline addresses unmet medical needs
    with a target market that is expected to grow significantly, reaching
    more than $1 billion annually by 2010 in North America alone.
    Marillion is a spin-out company from the University of Pennsylvania
    and was founded in February 2005 following seed funding received from
    BioAdvance. Series A funding was received from APIDC/Venture East.
    Visit www.marillionpharma.com for more information.