Biotech Values

[DewDiligence]

Article on AMD program for OXGN’s C4AP:

http://www.revophth.com/index.asp?page=1_393.htm [Scroll down on page --thx to “vassego” on Yahoo for this catch]:

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A new Phase I/II clinical trial is under way at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine to determine the safety and efficacy of the vascular-targeting agent Combretastatin A4-phosphate Prodrug (Oxigene Inc., Watertown, Mass.) for the treatment of wet age-related macular degeneration.

The trial marks the first attempt by researchers to test a vascular-targeting agent in humans with AMD. CA4P has been shown to destroy established and developing blood vessels and cause choroidal neovascularization regression in preclinical animal models. CA4P, initially developed to impart selective toxicity to tumor vasculature, is being studied in three human cancer trials. The compound is originally derived from the root bark of the South African Combretum caffrum willow tree.

The Phase I/II trial, sponsored by the Foundation Fighting Blindness, is led by Quan Dong Nguyen, MD, MSc, assistant professor of ophthalmology, and Peter A. Campochiaro, MD, the George S. and Dolores Eccles professor of ophthalmology, and director of the Vitreoretinal Service at Johns Hopkins.

The study will include approximately 20 patients who will be assigned to one of three treatment arms to receive 27 mg/m2, 36 mg/m2 or 45 mg/m2 of CA4P once a week for four weeks.

Researchers will monitor patients for six months to measure visual-acuity outcomes, macular thickness and changes in CNV lesion sizes. “A larger Phase II study will follow, depending on results of this initial trial,” says Dr. Nguyen, the principal investigator. “Our goals are to stabilize visual acuity and perhaps restore lost vision in these patients.”

Unlike anti-angiogenesis drugs such as Lucentis (rhuFab V2, Genentech) and Macugen (pegaptanib sodium, Eyetech) that prevent new blood-vessel growth by inhibiting vascular endothelial growth factor, CA4P “is a naturally occurring structural analog of colchicine, which binds tubulin at the same site as colchicine but has a different mechanism of action,” says Dr. Nguyen. “This compound takes on neovascular AMD through a different approach than [that of] Lucentis and Macugen.”
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