Generex Creates Own Regulatory Reality

The FDA Web site explains that expanded access to unapproved drugs is "sometimes referred to as 'compassionate use'..."

FDA granted Treatment IND status to Oral-lyn seven months ago, but to date no diabetes patient in the U.S. has participated in the program nor have any patients been treated with Oral-lyn, according to Steve Rubinfeld, president of TS Biopharma, the contract research company put in charge of the Oral-lyn expanded access program by Generex.

TS Biopharma is still identifying research sites, said Rubinfeld, the son of Joseph Rubinfeld, Generex's chief scientific adviser. On April 13, Generex said the John Muir Physician Network Clinical Research Center, located in the San Francisco suburbs, would participate in the Oral-lyn Treatment IND program. An employee of John Muir confirmed the center's participation in the Oral-lyn expanded access program, pending final approval from its institutional review board.

Currently, Dr. Dennis Gage of New York's Beth Israel Medical Center is listed as the only doctor participating in the Oral-lyn expanded access program, according to the U.S. government's ClinicalTrials.gov web site.

Gage would not comment on his involvement with Oral-lyn, referring all inquiries about the drug and the expanded access program to Generex.

In April 2008, Generex received authorization from Health Canada, the regulatory equivalent to the FDA in that country, to start a Special Access Program (SAP) for Oral-lyn. Like the FDA's Treatment IND program, Canada's SAP provides access to life-threatening conditions when conventional therapies have failed, are not available or unsuitable.

Since April 2008, Health Canada has authorized access to Oral-lyn on two occasions, each time for the same physician on behalf of the same patient, said Christelle Legault, media relations officer for Health Canada.

TheStreet previously reported that the drug regulators in India revoked their decision to approve Oral-lyn's use in that country in March 2009, but to this day, Generex has not said anything publicly about the Indian government's action, nor has the company informed investors that Oral-lyn is no longer for sale in India.

How much longer do investors need to wait before Generex produces something more tangible concerning Oral-lyn and its U.S. expanded access program than talk and promises?

-- Reported by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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