for the Treatment of Colon Cancer
OncoVAX® is an investigational active-specific immunotherapeutic for the post-surgical treatment of patients diagnosed with TNM Stage II colon cancer. OncoVAX® is prepared for each patient using the patient's own surgically removed tumor. After receipt at an OncoVAX® center, the tumor is enzymatically treated, frozen, and irradiated to render the cells non-tumorogenic. The patient receives the first of four vaccinations several weeks after surgery. The vaccine consists of a portion of the tumor cells that has been thawed and combined with a proprietary formulation of Bacillus Calmette Guérin ("BCG") that serves as an immunogenic enhancer. This formulation is also used for the second inoculation. The third inoculation and the final booster inoculations are prepared the same way but without the addition of BCG.
Intracel tested OncoVAX® in a prospectively randomized multi-center Phase III clinical trial (the "Pivotal Phase III Trial"). The Pivotal Phase III Trial was conducted at the University Hospital, Vrije Universiteit, Amsterdam. Twelve hospitals within a four hour radius of the University Hospital screened potential candidates for the protocol. The potential candidate's colon resection was performed at one of the twelve hospitals, and the tumor specimen was transported to the University Hospital's vaccine production laboratory for processing.
Intracel believes the clinical data from the Pivotal Phase III Trial demonstrates that, at a median follow-up period of 5.3 years after treatment with OncoVAX® significantly reduces the rate of tumor recurrences by 44% in patients with Stage II and III colon cancer. In Stage II patients, OncoVAX® had the greatest impact with a statistically significant 61% reduction in the rate of recurrences, along with proportional increases in overall survival. In addition to its efficacy, Intracel believes OncoVAX® clinical studies demonstrate an extremely favorable safety profile.
Intracel is now preparing a BLA for OncoVAX® for submission to the FDA. This application, if approved, will allow the use of OncoVAX® in the treatment of patients presented with Stage II colon cancer in the United States. A study in Stage III colon cancer patients using OncoVAX® in combination with chemotherapy is also planned in the U.S.
In the Netherlands, OncoVAX® is already commercially available for the treatment of Stage II patients. Intracel is seeking the necessary registrations and reimbursement approvals in certain countries in Europe.
Intracel plans to initially establish two OncoVAX® Manufacturing Centers on the east and west coasts in the United States and one OncoVAX® Manufacturing Center in The Netherlands. Each center will be responsible for receiving tumors from colon resections performed at hospitals throughout the United States or Europe. These Intracel-operated laboratories will adhere to current Good Manufacturing Practices ("cGMP"). Intracel, directly or under contract, will take full responsibility for collection of the tumor from the operating room and transport to the Manufacturing Center. Upon the tumor's arrival at the Manufacturing Center, Intracel employees will be responsible for dissociation of the tumor and preparation of the biological product including freezing, irradiation and frozen storage of the biological product.
The biological product is shipped frozen to Intracel-approved affiliated sites for storage and compounding of the patient dose, and either administration to the patient, or shipment to a site for administration. Under most circumstances the affiliated site will be a pharmacy which has the capacity to operate under Good Pharmacy Practices ("GPP") including aseptic handling of products.
More information on OncoVAX® can be obtained by calling the Intracel OncoVAX® Information Line at (610) 402-5707, or by sending an e-mail to Sarah Stevens, M.D., at firstname.lastname@example.org.
Information on Intracel Clinical Trials can be obtained by calling William E. Gannon, M.D., Clinical Trials Department, at (301) 258-5200 x1176 or by E-mail at email@example.com.