Following the phase 1a trial of Andes-1537, where some preliminary signals of efficacy were observed in patients with abdominal cancer, an open, multicentric, two stage phase 1b trial was initiated to investigate the safety and tolerability of the drug in cancer patients from 6 cohorts, associated to six different cancer type: gallbladder and biliary tract carcinoma, cervical carcinoma, colorectal carcinoma, gastric carcinoma, pancreatic carcinoma and clear cell renal cancer. The study will recruit patients that are refractory or resistant to current treatment options.
The trial is conducted in Chile in collaboration with the CRO Thera Research, company specialized in clinical trials and local regulatory affairs.
About Andes-1537
Andes-1537 is a short single stranded phosphorothioate deoxyoligonucleotide which binds by base pairing to one of 2 newly discovered non-coding RNAs, named Antisense non-coding mitochondrial RNA (ASncmtRNA). The resulting RNA-DNA hybrid is then hydrolyzed by two cellular RNases: RNase H and DICER resulting in microRNAs. In vitro experiments with cells have shown Andes-1537 affects cancer cells by a) inducing apoptosis by lowering the expression of anti-apoptotic proteins such as survivin b) decreasing proliferative signaling through inhibition of the expression of proteins such as cyclin D1 and cyclin B1, and c) inhibition of tissue invasion/metastatic proteins such as n-cadherin, B-catenin and metastasis inducing factors.
About Andes Biotechnologies (www.andesbio.com)
The aim of Andes Biotechnologies is to carry out research and development of new anticancer therapies based on the inactivation of novel non-coding mitochondrial RNA targets through anti-sense technology. Andes has a portfolio of more than 70 patent in key markets around the world, covering the diagnostic and therapeutic uses of non-coding mitochondrial RNA oligonucleotides which have the potential of selectively eliminating tumor cells without harming normal cells in many Cancer types. The company has a management team with extensive experience in drug development and biotechnology research, which has successfully developed, patented and registered products currently marketed in the U.S. and Europe.
About Thera Research (www.theraresearch.com)
Thera Research ltd. is a Clinical Research Organization (CRO) based in Chile specialized in Clinical Trials Management that offers full support in planning, running and reporting Phase I-IV Clinical Trials for pharmaceutical, biotechnology, generic drug, OTC/consumer healthcare and medical device companies. Experience in Inspections of the Local regulatory agency MoH/ ISP (Ministry of health/ Instituto de Salud Pública).
