Trial of indigenous cancer vaccine enters 2nd stage

To be administered to nearly 35 cervical cancer patients

India’s first therapeutic anti-cancer vaccine has begun the second phase of the clinical trial after successfully completing the first leg.

As many as 36 cervical cancer patients will receive the indigenous vaccine, developed by the National Institute of Immunology (NII), along with concurrent chemo-radio therapy in the next one-and-a-half years.

Oncologists at the Cancer Institute, Adyar, Chennai, will  then compare the responses of patients with SPAG-9 vaccine shots with another group of 18 patients who will receive the standard treatment. The trial’s second phase was launched in Chennai earlier this week, following successful results of the first phase that took place between 2002 and 2006.

The gap of 10 years was utilised to create a special clinical trial ward at the Chennai institute and manufacture the vaccine in a world-class industrial facility, owned by Biocon, for administering it to a large number of patients.

“We had to take those steps because of stringency in clinical trial norms. As the second phase rolls out, we expect to get the results by 2019,” NII deputy director Anil Suri, whose team developed the vaccine, told DH.

Initially, advanced stage cervical cancer patients will receive the indigenous vaccine along with the standard therapy. If the results are encouraging, the researchers may try it on breast or ovarian cancer patients at a later stage.

“The trial is an effort to improve survival in locally advanced cervical cancer. Annually, there are nearly one lakh new cervical cancer cases, of which a minimum of 60-65% will be locally advanced cases. This vaccine will be in addition to the existing chemo-radiation,” said V Shanta, chairman of the Cancer Institute.

Unlike the two commercially available preventive vaccines against cervical cancer, SPAG-9 is a therapeutic vaccine that works around a new cancer treatment modality called dendritic cell therapy, in which a patient’s own immune cells are used to fight cancer.

Doctors are hopeful about its future because of one patient, who received the vaccine in the first phase of the clinical trial.

Her cancer was so serious that it even spread to the lungs. She was first given three shots of the indigenous vaccine followed by chemotherapy, resulting in the elimination of the cervical cancer and regression of the lung lesion.
DH News Service