Overview RENCAREX®
ENGLISH DEUTSCH
| Compound Class | Chimeric monoclonal antibody |
| INN (International Nonproprietary Name) | Girentuximab |
| Indication | Clear cell renal cell cancer (ccRCC) and other solid tumours |
| Target | The Antibody Girentuximab binds specifically to the protein structure carbonic anhydrase IX (also called CA IX, MN or G250 antigen). CA IX is expressed on the cell surface of clear cell renal cell carcinomas but not on healthy renal tissue. The protein is also present in a variety of other solid tumours, e.g. bladder- and colon cancer. |
| Mode of Action | ADCC* |
| Development Status | Pivotal Phase III trial with RENCAREX® as adjuvant therapy of patients with non-metastatic clear cell RCC at high risk of relapse after surgery. RENCAREX® has completed clinical Phase II trials in combination therapy with cytokines (IL-2 and IFN) in patients with metastatic RCC. |
| Orphan Drug Status | Orphan Drug Status for the U.S. and the EU in the indication RCC. |
| Fast Track Status | Granted by FDA in october 2011 |
| Partner | WILEX has granted Laboratorios del Dr. Esteve S.A. the commercialisation rights on RENCAREX® in certain countries of South Europe including Spain, Italy, Portugal, Andorra and Greece.In April 2011 WILEX granted US commercialisation rights for RENCAREX® to Prometheus Laboratories Inc. |
| Development Rationale | Standard therapy for non-metastatic clear cell RCC is resection of the affected kidney and any associated tumour mass followed by observation. There is no adjuvant treatment approved by the FDA** or EMEA** for patients after surgery, although there is a high relapse rate among patients after surgery. RENCAREX® has proven to be safe and well-tolerated and is therefore ideally suited for this area of high medical need. |
| History | RENCAREX® is a targeted antibody for the treatment of solid tumours. The G250 antibody was originally developed at the University of Leiden, Netherlands, by a team led by Prof. Sven Warnaar, who joined WILEX in 1999 and served as the Company’s Chief Scientific Officer until he retired in June 2003. |
* Antibody-dependent cellular cytotoxicity (“ADCC”) is the mechanism by which antibodies induce natural killer (“NK”) cells or other effector cells of the patient’s immune system to destroy tumour cells.
** FDA: Food and Drug Administration, EMEA: European Medicines Evaluations Agency
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