Clinical Development

Present

Angiogen is currently conducting Phase I clinical trials necessary for FDA approval. The trial involves patients who have otherwise failed cancer therapy. The present and ongoing Phase I trial has reinforced the earlier positive data, with most of Cohort Group I completing treatment and two patients exhibiting partial tumor necrosis. Results from cohort group I have proven incontrovertibly that the Angiostatic Cocktail generates Angiostatin4.5 with minimal side effects.

Angiogen expects to treat approximately twenty patients during the current Phase I trial. The trial consists of three cohort groups, with successive groups receiving escalated dosages to assist Angiogen in determining the optimal amount of drug necessary to generate sufficient amounts of Angiostatin4.5 to inhibit angiogenesis. Cohort group I has received plasminogen activator dosages of 5 mg/hr, 7.5 mg/hr and 10 mg/hr for six hours per day, five days a week, every other week. Cohort group II will receive plasminogen activator dosages of 7.5 mg/hr, 10 mg/hr and 15 mg/hr for six hours per day, five days a week, every other week. Angiogen expects to see escalated generation of Angiostatin4.5 and a concomitant increase in anti-tumor activity as doses escalate.

Angiogen is also treating transgenic mice (mice with human plasminogen) in parallel with the human trials. Three cohort groups have been treated: (i) a group with no treatment; (ii) a group receiving chemotherapy; (iii) a group receiving the Angiostatic Cocktail, which elicited in the best results in the study. The rodent studies are helpful in allowing for the validation and development of the Angiostatic Cocktail in a more efficient manner than can be achieved in human cancer patients. In the next round of rodent studies, Angiogen will use the Angiostatic Cocktail and chemotherapy adjunctively.

Read the history of Angiogen's clinical development efforts...