The work consists on the pharmacological characterization live and in vitro, and on the clinical initial development of h-R3 molecular antibody developed in the Center of Molecular Immunology (CIM).

The product h-R3 is a recombinant molecular humanized antibody that recognizes with high affinity the receiver of Epidemic Growth Factor (EGF). It has as antecedent ior-egf/R3 murine monoclonal antibody, which received a prize from ACC in 1995 for its use as immuno diagnostic radius and obtaining the recombinant humanized antibody, which received a prize in 1998.

This work includes :< /p>

• 1. The experiments where the antiprolific activity of ACM h-R3 is demonstrated, as well in vitro as live in SCID mice, in the line A431, rich in receivers for EGF, from a vulvar carcinoma, where it also shows pro-apoptotic and anti-angiogenic action for inhibition of the production of vascular endothelium growth factor (VEGF). There are also studied the resistance development mechanisms on those cells to the treatment with H-R3, based on the selection of cellular populations with adult potential angiogenic. These results are published in articles in International Journal of Cancer and Cancer Research magazines,
• 2. Phase 1 from the clinical trial in twelve patients with advanced tumors of epithelial origin, with escalade dosis of h-R3 dose, where it is studied the security profile of the product and pharmacokinetic and biodistribution studies of a fraction of the monoclonal that was administered and marked with 99mTc. These results are sent to be published in Journal Immunotherapy magazine, which reception documentation is presented,
• 3. Phase I/II from clinical trial in 14 patients with head and neck tumors with high expression of EGF receiver, subsequently extended to 24 patients, combining h-R3 use with radiotherapy, where, besides corroborating the profile of acceptable security of the product, it was obtained a high rate of objective antitumoral response (18/22=82%), complete in 59% (13 patients). This effect is apparently a dependent dose because it was more evident in the highest dose levels. They are very superior to those habitually obtained in these.

These results have been presented in ASCO meetings in 2001 and 2002. With these pre-clinical and clinical results, together with the clinical pharmaceutical development of the product, the Center for National Control of the Quality of Medicines (CECMED) granted the registration conditioned to the termination of phase II from the controlled study in course. On the other hand, the project has been very successful as for negotiations in Canada, China, Italy, South Africa and Mexico.