RECEPTA biopharma will generate protocols and conduct Phase I and Phase II clinical trials with its monoclonal antibodies. These protocols are being prepared by the Company's oncology team, coordinated by its Medical Director, Dr. Oren Smaletz, in close collaboration with scientists from the Ludwig Institute for Cancer Research. The trials will be conducted with strict observance to both Brazilian and international standards in order to guarantee their licensing on the international market. These studies will be performed at hospital Centers of Excellence that have proven experience in clinical testing.
The first clinical trial by RECEPTA biopharma will be a Phase II study with the mAb hu3S193 (anti-Lewis Y) on patients with ovarian cancer. The corresponding Phase I studies have already been completed by the Ludwig Institute for Cancer Research. This first protocol was prepared by Dr. Oren Smaletz, RECEPTA biopharma's Medical Director, in collaboration with scientists from the company Biocancer, headed by oncologist and clinical trial expert Dr. Alberto Wainstein, Ph.D. EuroTrials, a highly regarded Contract Research Organization (CRO) with vast international experience, has been contracted to monitor the execution of this protocol.
Recepta’s first clinical trial will be a phase II study for ovarian tumor patients with mAb hu3S193 (anti-Lewis Y). The protocol has been already approved by Brazilian IRB’s and also by ANVISA, Brazil’s regulatory agency. Patient enrollment should start in the first semester of 2008. The protocol has already been registered at the National Cancer Institute website and will be filed under the existing IND at the FDA.