A Cuban clinical trial will evaluate a potential blockbuster drug

José A. Acosta, Ernesto L. Mola, Ricardo S. Rodríguez, Boris E. Acevedo, Luis H. Martínez.

Havana - February 6, 2006. The Centre for Genetic Engineering and Biotec hnology (CIGB), Havana, Cuba, initiated last week the first clinical trial worldwide to inhibit the protein kinase 2 (CK2) phosphorylation. It was approved by the National Regulatory Authority for starting the Phase I clinical trial of CIGB-300: a new molecular entity for cancer.

The purpose of the trial is to assess the safety and performing a dose scale-up study of the CIGB-300 in patients with Cervical Intraepithelial Neoplasia (CIN-II) and Carcinoma in situ (CIS), who have failed to respond to available treatments. CIGB-300 is a pro-apoptotic cyclic peptide that blocks the protein kinase 2 (CK2) phosphorylation and exhibits antitumor effect in vivo . Tumor cell lines and relevant tumour models were used to investigate the potential anti-neoplasic effect of such a peptide inhibitor both in vitro and in vivo (Cancer Research 64, 2004: 7127-7129). The Phase I trial is being conducted at two cancer centers in Havana . This project is inserted within a non-disclosed Agreement between CIGB-Heber ( Cuba ) and Biorec (The Netherlands).

This is an open-label, dose scale-up study designed to accommodate between 28 and 40 patients. This four-step clinical trial will be performed in 20 weeks, starting from the enrollment of 7 patients with CIN-II and CIS. Before starting each step, no severe adverse event, with demonstrated causality relationship, can take place during the foregoing step in more than 20% of patients.

Cervical Intraepithelial Neoplasia (CIN) is a cervical condition caused by a sexually transmitted virus called the Human Papilloma Virus. CIN is also called Cervical Dysplasia. CIN is classified as I, II or III depending on its severity. It is considered a pre-cancerous abnormality, but not a real cancer. The mildest form, CIN-I, usually goes away on its own, although rarely it can progress to cancer. The more severe forms, CIN-II and CIN-III, most often stay the same or get worse as the time goes by. They can become a cancer, but almost never do if treated adequately.

About the CIGB

The CIGB, a vanguard institution in the Life Sciences in Cuba , is a large research-production complex, endowed with the state of the art equipment, production capacities and personnel devoted to the development of new biotechnology products in all stages, from the cloning and expression using recombinant DNA technology to industrial production. The CIGB has extensive experience in the recombinant DNA technology dated back to 1980, with more than 1300 employees, owning the most modern and efficient technology, carefully studied-beforehand facilities so as to ease the quiet and continuous workflow with a total area of more than 70 000 m 2 . The CIGB is looking for corporate partnership for joint development of R&D projects.

For information: http://gndp.cigb.edu.cu or http://www.cigb.edu.cu

Contact: ernesto.lopez@cigb.edu.cu

Phone: (53-7) 2712397.