Pre clinical and Clinical studies of Combination HER-2 /neu
Pre clinical and Clinical studies of Combination HER-2 /neu: Pravin T. P Kaumaya, PhD, The Ohio State University Medical Center and The James Cancer Hospital, 420 W12th Avenue, Suite 316, Columbus, OH 43210.
The American Cancer Society estimates that 21,550 new cases of ovarian will be diagnosed in the US in 2009 with 14,600 deaths predicted. Of 192,370 newly diagnosed breast cancer pa-tients, some 40,170 people will die from the disease. Ovarian Cancer is the second most com-mon gynecologic cancer, with an incidence of about 15 cases per 100,000 women in western countries, and approximately 250,000 new cases and 125,00 deaths worldwide annually.
The NCI Strategic plan to defeat Cancer by 2015 is in tune with the Comprehensive Cancer Center goals: To improve people's lives through innovation in research, education and patient care. Thus, the goals of developing "effective treatments to treat malignancy by either destroying all cancer cells or modulating and controlling metastases both with minimal harm to healthy tis-sue" mean integrating preclinical and clinical research and to translating research into high-quality patient care for residents of central Ohio and beyond. That means developing novel prophylactic as well as therapeutic vaccines and treatments. Stimulating the immune system to destroy tumor cells has long been a hope, and the realization of this dream is beginning to show signs of success.
The Kaumaya Laboratory in the Comprehensive Cancer Center of the Ohio State University has successfully completed a first woman/man Phase 1 vaccine NCI-funded, FDA approved trial in patients with metastatic and/or recurrent solid tumors in the James Cancer Hospital in December 2008. The vaccine targets both +ve and -ve HER-2 as well as EGFR overexpressing cancers. Twenty four end stage cancer patients who have failed all prior therapies were enrolled in the study and received three immunizations of the combination HER-2 peptide vaccines. The results demonstrate that this vaccine strategy was well tolerated with little or no toxicity in patients with advanced malignancy. A subset of patients produced a robust antibody response generated to the vaccine at the highest dose level. Six (25%) patients were classified as having clinical bene-fit: 4 patients (colon, SCC, adrenal and ovarian) with stable disease and 2 patients (Endometrial and ovarian) with a partial response. These patients were eligible for and received a 4th inocula-tion six months after receiving the 1st inoculation. Additionally, one patient (endometrial cancer) received a 5th vaccination 3 years from the patient's first vaccination.
In August 2009, the Kaumaya laboratory received $750,000 from the NIH/NCI to test an im-proved vaccine formulation in a new Phase I Clinical Trial in Cancer Patients to begin in 2010. Additional funding is required to move this trial forward to completion given the budget from NIH was slashed by 10% and the higher cost of vaccine manufacturing. Some of the more lethal cancers including ovarian cancer, breast cancer, non-small lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, and gastro-esophageal cancers are being targeted by this novel vaccine. The CCC team is being led by Pravin Kaumaya, PhD ; William Carson,MD; Tanios-Bekaii-Saab, MD; Charles Shapiro, MD and JeffreyFowler, MD.