Andes Biotechnologies has just been cleared by the FDA to start clinical trials in the US

September 25, 2015

Andes Biotechnologies is a Chilean company that is developing a cancer therapy based on the inactivation of a novel non-coding mitochondrial RNA by means of anti-sense technology. The company has a management team with extensive experience in drug development and biotechnology research, which has successfully developed, patented and registered products marketed in the U.S. and Europe.

The Food and Drug Administration (FDA) activated an Investigational New Drug (IND) Application on September 13th for the start in the US of Phase I clinical trials of a new cancer drug developed by Andes Biotechnologies. The upcoming study will be conducted by Dr. Pamela Munster, Director of Early Phase Clinical Trials Unit and Leader of Developmental Therapeutics Program at the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, CA (For more information on the trial, please visit: https://clinicaltrials.gov/ct2/show/NCT02508441).

The product, called Andes 1537, has already been tested in animal cancer models, specifically mice and monkeys, where the treatment has proven both universal and innocuous. Indeed, Andes 1537 selectively destroys the tumors, leaving normal cells virtually intact. Moreover, it is the first biomedical development that has been invented, developed and financed in Chile, while also being cleared for clinical trials in the US.

The story started around the year 2000, when Dr. Luis Burzio discovered a new family of RNAs of mitochondrial origin, which after many tests proved to be a promising universal target for both cancer treatment and diagnosis. On 2009 Dr. Burzio was joined by Dr. Pablo Valenzuela and Arturo Yudelevich to found Andes Biotechnologies, company that has obtained 29 patents worldwide, and has become a standard for biotechnology innovation in the country.

Andes Biotechnologies’ team celebrating the good news. Andes 1537 is the first biomedical development that has been invented, developed and financed in Chile, while also being cleared for clinical trials in the US.