October 4, 2004.
American City Business Journals.
Genaera Corp. of Plymouth Meeting, Pa., said Monday it has received "fast track" status for its experimental drug Squalamine as a potential treatment for "wet" age-related macular degeneration.
The fast track designation by the Food and Drug Administration is given to expedite the review and facilitate the development of a new drug that demonstrates the potential to address unmet medical needs for the treatment of a serious or life-threatening condition.
Wet AMD is the leading cause of legal blindness among adults age 50 or older. About 25 million to 30 million people are affected globally, and the number is expected to triple during the next 25 years.
Squalamine, a compound derived from a substance found in the liver of the dogfish shark, is also being tested as a potential treatment for cancer.
Genaera is testing the new drug candidate for wet AMD in three, phase-II clinical trials.
Dr. Roy C. Levitt, the company's president and CEO, said Genaera anticipates reporting early data from its first phase-II study later this year followed by additional phase-II data during the first half of next year. The company intends to begin phase-III in the first half of 2005 that will run concurrently with its largest phase-II trial.
Phase-III trials are typically the last step a company takes before seeking approval for an experimental drug from the FDA.
© 2004 American City Business Journals Inc.
Source URL: http://www.bizjournals.com/philadelphia/stories/2004/10/04/daily3.html.
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