The Cleveland Clinic Seeks FDA Approval for Phase I Clinical Trials of Preventive Breast Cancer Vaccine

By Vera Viner

As many of you may have heard by now, the Cleveland Clinic along with the Breast Health and Healing Foundation and countless other organizations and cancer survivors are rejoicing because Dr. Vincent Tuohy’s preventive breast cancer vaccine is awaiting approval from the U.S. Food and Drug Administration (FDA) to test the vaccine as a new drug in proof-of-concept, human clinical trials.

Cleveland Clinic Innovations developed a new spin-off company called Shield Biotech to take part in preclinical development of the vaccine and seek FDA approval, according to a press release from the Cleveland Clinic.

“The mission of Shield Biotech will be to translate the scientific research on a breast cancer vaccine, led by Vincent Tuohy, Ph.D., at Cleveland Clinic, into a viable preventive alternative for the patients who may benefit,” Dr. Thomas Graham, Cleveland Clinic’s Chief Innovation Officer, said in the press release. “We believe that the vaccine has the potential to stop the more lethal forms of breast cancer, as well as inhibiting the recurrence of triple-negative breast cancer in women after they have recovered from their initial disease.”

Essentially, the FDA will need to approve the breast cancer vaccine for Phase I clinical trials to determine if it is safe for use in women. The research behind the vaccine is so important because it could save the lives of future generations. It could make a huge difference for the young girls and daughters in our lives.

This is why the FDA Fast Track Development Program may be the right area to look into to have the vaccine available for testing as soon as possible. The FDA Fast Track Development Program accelerates the approval of new drugs undergoing clinical trials with a goal to finish reviewing the evidence of each drug within 60 days. This is a status that is obtained by promising drugs that treat severe, life-threatening medical disorders with no substantial pharmacological treatment.

The whole point of this program is to fast-track the drugs for quick delivery to the patients who need them most. There are specific requirements for a drug to gain the status for fast-tracking. These include:

1. Medication that could be used as a treatment or preventive measure for a disease that does not have adequate therapy or is labelled with an unmet need

2. Shows exceptional effectiveness

3. Lacks any serious side effects of current treatments

4. Improves diagnosis of a serious disease

5. Decreases the toxicity of a clinically accepted treatment

6. Ability to address a public health need

Some of the benefits of this program is the frequent meetings of FDA members to discuss the development plan, more plentiful written correspondence with the FDA regarding design of clinical trials, eligibility for accelerated approval, rolling review, and dispute resolution if a company is not satisfied with the FDA decision.

According to the FDA website, some serious conditions the organization would consider for fast-tracking a treatment include AID’s, Alzheimer’s disease, heart failure, cancer, epilepsy, depression, and diabetes.

This overview on the FDA Fast Track Development Program leads one to ponder on the possibilities available for Dr. Vincent Tuohy’s preventive breast cancer vaccine. Now that the funding for Phase I clinical trials is finally here, it is time to await FDA approval.