The Center of Molecular Immunology received a Fast Track Regulatory Approval for TheraCIM h-R3, a new drug for the treatment of Epidermal Growth Factor Receptor (EGF-R) positive advanced Head and Neck tumors.

Havana, Cuba. – March 5, 2002.- The Center of Molecular Immunology (CIM, Havana, Cuba) and its commercial branch CIMAB SA ( www.cim.sld.cu  ) announced today that TheraCIM h-R3, a humanized monoclonal antibody, has received a Fast Track approval as a combination therapy with external radiation for advanced head and neck cancer by the National Regulatory Authority of Cuba The Center for State Control of Quality of Drug (CECMED, Havana, Cuba).

TheraCIM h-R3 is manufactured by CIM and was co-developed by CIM, CIMAB and YM BioSciences inc. (Ontario, Canada, www.ymbiosciences.com ) through its joint venture alliance CIMYM inc. (Ontario, Canada). YM BioSciences inc., a Canadian company incorporated in 1994, licenses and develops innovative cancer therapeutics. It partners with biotechnology and pharmaceutical companies, as well as with drug discovery organizations and academic institutes, to develop cancer treatment applications of their novel agents and technologies. The Company in-licenses drug products and takes them through the development process, including regulatory affairs and clinical research, toward preparation for regulatory approval.

TheraCIM h-R3, CIM’s humanized anti-Epidermal Growth Factor Receptor (EGF-R) antibody, a type of EGF-R inhibitor which represent a promising class of novel anti-cancer drug and a new target approach developed for the treatment of advanced head and neck tumors in combination with external radiotherapy. TheraCIM h-R3 is an specific and active inhibitor of the EGF-R tyrosine kinase phosphorylation, that is associated with the aberrant growth characteristic of certain cancer cells. The proposed use of TheraCIM h-R3 is for 80-90 percent of advanced head and neck patients with this disease who have tumors that produces excessive amounts of, or over-express EGF-R. EGF-R over-expression is associated with bad prognosis, progression, shortened survival and resistance to chemotherapy or hormone therapy.

Agustin Lage Davila, Ph. D., CIM’s General Director believes “TheraCIM h-R3’s approval by CECMED, the Cuban National Regulatory Authority has special significance for the center and for the Cuban Biotechnology. A significant research effort was mounted to develop the humanization technology, for clinical development program, regulatory issues and manufacture of this product”, he said. TheraCIM h-R3 is an original product from Cuban science, with a patent granted in major biotech markets USA, Canada, Europe and China.

TheraCIM h-R3 is the first humanized monoclonal antibody for the treatment of EGF-R over-expressing advanced head and neck cancer and the third approval; in this new class of biotherapeutic cancer drugs for solid tumors. The first was Panorex, developed by Centocor inc. (New Jersey, USA) and approved in Germany in 1994 for use in patients with colon cancer which has spread to the nearby lymph glands (nodes) and the second Herceptin developed by Genentech inc. (San Francisco, California, USA) approved in September 1998 for the treatment of metastatic breast cancer in combination with chemotherapy.

Clinical Trials Results.

TheraCIM h-R3 in combination with external radiotherapy in a large number of patients was shown to produce a favorable therapeutic response, improving in Cuba the complete response rate (cure of the tumor) from 30 percent for head and neck patients treated with radiotherapy alone to a 60 percent with TheraCIM h-R3 added to radiotherapy, a two fold increase. The duration of the response for the first patients treated accounted on more than 24 months. The overall response rate (complete response and partial responses) and survival advantage shown is particularly notable. CIM together with the National Institute of Oncology and Radiobiology (INOR, Havana, Cuba) are conducting follow up studies.

TheraCIM h-R3 was generally well tolerated by all patients treated in clinical trials. Overall the most common adverse events associated with TheraCIM h-R3 are related to the intravenous infusion, itself, and involve mild to moderate fever, chills, and nauseas in approximately 45 percent of patients, primarily with the first infusion. With this product administered by intravenous infusion together with external radiotherapy for the treatment of advanced head and neck tumors never had been noticed severe allergic reactions or skin rash in any of the treated patients.

“These are important results for patients with this very aggressive form of advanced head and neck tumors” said Tania Crombet Ramos, MD, CIM’s Head of the Immunopharmacology Department, “Few therapies have demonstrated an overall response rate and survival benefit in this disease”.

In 2001, world figures of head and neck cancer was estimated as 454 446 new cases, including 266 672 cases of cancer in the oral cavity, 64 796 cases in the nasopharynx and 122 978 cases in other parts of the pharynx. Head and neck tumors was the cause of 244 413 deaths around the world, including 57 174 in more developed countries and 187 247 deaths in less developed countries. According to the 5-year prevalence of head and neck cancer for the year ending in 2001 the number of cases was estimated as 1 127 428, including 707 148 cases of oral cavity cancer, 171 461 cases of nasopharynx cancer and 248 819 cases of other type of pharynx cancer. There is an estimation of approximately 225 486 patients with non resectable head and neck advanced tumors; of these patients 80-90 percent have tumors that over-express EGF-R and may be candidates for TheraCIM h-R3

CIMAB SA is the commercial branch of the Center of Molecular Immunology (CIM). CIM is one a the centers of the Scientific Pole in Cuba devoted to research, development and manufacturing human biotech products, and CIMAB the marketing company. CIM research programs are focused in the areas of cancer therapeutics, autoimmune diseases and renal transplant. CIM utilizes its platform technology and development capabilities to facilitate the rapid and cost-effective discovery and development of novel anti-cancer drugs.

For more information, please contact:

Normando Iznaga-Escobar, MSc
Business and Development,
CIMAB SA
Street 206, No. 1926, Atabey, Playa,
Havana 11600, Cuba

Phone: (53 7) 271 5057, 271 6275
Fax: (53 7) 33 3509, 33 5049
Email: normando@ict.cim.sld.cu 
Web page: www.cim.sld.cu