In this blog I seldom quote or provide hyperlinks to press reports because they too often contain misleading information. Yet, today’s DIA web summary contained an article that I just have to correct. The article was a summary of a report on Medpage’s website. The report’s heading is inadvertently correct: “FDA Finds Oral Insulin Spray Safe for IND Use“; in order to commence an IND, the sponsor must convince the Agency that the proposed product is sufficiently safe for testing in humans. What is incorrect is the statement: For a drug to receive IND approval, it must demonstrate efficacy during clinical trials.” Definitely not true since in Phase 1 you only show safety. Phase 2 is where you begin to show efficacy.
Where the authors got it wrong is that Generex is in Phase III trials, requested and received permission from FDA for a treatment IND. This spelled out correctly in the Generex press release.
The FDA provides treatment INDs as a means to allow early drug access to patients who have an unmet critical need when such patients don’t otherwise qualify for the Phase III trial(s).