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Regen files IND application for dCellVax with FDA to treat breast cancer

Regen BioPharma has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to begin a clinical trial evaluating safety and therapeutic effects of its immunotherapeutic product, dCellVax, to treat patients with metastatic breast cancer.

dCellVax uses the patient’s own immune cells to attack the tumor and its success in the proposed trial is expected to pave the way for expanded use of the product in several other tumors.

Advantages of cancer immune therapies include lack of toxicity, ability to attack tumor metastasis, and generation of immunological memory, which protects the body from recurrence of the tumor.

Regen BioPharma president and CEO David Koos said: "We are thankful for Dr. Wei-Ping Min and his team at the University of Western Ontario, who have worked diligently with us over the last 18 months in making this IND application a reality."

dCellVax has been developed based on US patent, acquired from Dr Wei-Ping Min, as well as a collaboration between Dr Min and the company chief science officer Dr Thomas Ichim, which has spanned over ten years.

Ichim said the dCellVax approach to cancer is different than other gene silencing therapeutics currently in development.

"Most companies use gene silencing to block abnormal genes found in the tumor (oncogenes). Unfortunately, to get tumor cure with this approach, one would need to silence 100% of the cancer cells, otherwise, the remaining cells will continue to multiply," Ichim said.

"With the dCellVax approach, we are silencing genes that suppress the immune response to cancer. With this approach, even achieving silencing in 20% of immune cells is enough to cause an increased immune response, which hopefully will overcome the tumor.

"To our knowledge this is the first time that gene silencing is being proposed as a means of overcoming immune suppression in a clinical situation."