Generex unit expands AE37 study

Antigen Express, the vaccine subsidiary of Generex Biotechnology, has amended an agreement with the Henry M. Jackson Foundation for the Advancement of Military Medicine related to the ongoing Phase II clinical study of Antigen's AE37 novel immunotherapeutic vaccine for the treatment of breast cancer. As a result, the number of patients enrolled in the study will increase from 190 to 330.

In addition, the amendment will modify the inclusion criteria for new enrollees to ensure good representation of patient populations being considered for the Phase III trial. 

AE37 represents a new class of self-potentiating peptide vaccines designed to stimulate the immune system to specifically recognize and kill cancer cells, Antigen Express says in a statement. The company has announced interim data from the study indicating fewer relapses in the AE37 arm versus the placebo-controlled arm. The company anticipates that a Phase III trial of the breast cancer vaccine will begin prior to the completion of the Phase II study. Results from the ongoing Phase II study would be used for patient number adjustment, thereby assuring statistical significance in the Phase III trial.

Antigen Express recently completed a Phase I study of AE37 for prostate cancer, and a Phase I trial of the vaccine for ovarian cancer is under way.

Generex also announced that it has raised $3 million. Investors purchased $3 million worth of the company's common stock and can buy up to an additional $3 million in the next 60 days. As the Worcester Business Journal notes, Generex was recently delisted from the Nasdaq stock exchange because its share price was trading below $1, said it will use the money for research, development and preclinical trials.

- see the Generex release on the study
- and the Generex release on raising $3 million
- read the Worcester Business Journal report