Discovery of Angiocol™
Cancer tumors secrete molecules that stimulate surrounding tissues to develop new blood vessels, providing additional blood flow to the tumor. The process of capillary growth and development from pre-existing blood vessels is referred to as angiogenesis. Without an increased blood supply, the growth of a tumor would be substantially limited. A key step in the angiogenesis process is the synthesis of new vascular basal lamina, which is required to support and direct the growth and development of new capillaries.
The process of angiogenesis begins with the activation
An important focus of basal lamina research is the study
We have evaluated Angiocol™ in a number of angiogenesis models systems,
including a chimera tumor model that uses grafted human skin on NUDE mice,
The Company has initiated preclinical toxicology and we expect to file an investigational new drug application (IND) in 2001. Phase I trials should commence soon thereafter.
Phase I trials will examine the safety of increasing intravenous doses of Angiocol™ in cancer patients who have previously received various modalities of anticancer treatment, but have not been cured. We will also monitor these patients for tumor shrinkage over a period of 6 to 8 weeks. We expect to enroll approximately 30 to 40 patients in the Phase I trial.
Because Angiocol™ is an endogenous substance, it is expected that patients will experience little if any toxicity. This is in contrast to traditional cytotoxic drugs that have been used as cancer chemotherapeutics for decades, and which generally cause severe morbidity. This anticipated lack of toxicity makes Angiocol™ an ideal drug to combine with cytotoxic agents to treat cancer. The Company believes such combination regimens have the best chance of demonstrating anticancer activity in relatively healthy patients. Therefore, we expect that the planned Phase II clinical trial of Angiocol™ will be conducted in combination with other drugs in patients who are undergoing chemotherapy for the first time.Market Analysis and Projections
We anticipate that Angiocol™ will be administered will be administered intravenously as an adjunct therapy in combination with other chemotherapeutic agents. Initial disease targets for Phase II clinical trials are colorectal and melanoma.
According to the most recent statistics reported by the American Cancer
Society, 129,400 cases of colorectal cancer were diagnosed in 1999. Colorectal
cancer is currently the third most common cancer in American
Approximately 44,200 melanoma cases were diagnosed in the United States
in 1999. The American Cancer Society estimates that approximately 7,300
deaths were associated with this disease in 1999. Due to the high
We anticipate that Angiocol™ will be administered on an intermittent schedule in association with chemotherapy or radiotherapy. The product will most likely be administered once or twice a week over the course of the treatment period, which is estimated to be six to twelve months. Given these assumptions, we expect the average treatment costs for Angiocol™ to be approximately $15,000 per patient per year.
Because Angiocol™ is an anti-angiogenesis agent whose mechanism of action is not specific for a particular type of cancer, if proven to be efficacious against melanoma and colorectal cancers, it is likely that it would be prescribed for most cancers. The Company believes that Angiocol's™ unique basal lamina-based mode of action will make it more effective than other drug candidates that are currently undergoing development in this area. Whereas most drug candidates target only one mode of action, Angiocol™, via its basal lamina-based mechanism, attacks several molecular processes involved in new blood vessel growth.