There are four stages through which the development of a new drug passes
PHASE 1 also called "pilot", is used to evaluate the toxicity of the compound and allows to define the dosage with which it will be used in the subsequent phases of the experimentation. PHASE II: it is the moment of real research and exploration, which allows observe the action of the compound on small numbers of patients affected by a particular disease.PHASE III: it is used to compare the effectiveness of the new drug with a standard treatment, using other drugs or pleasure as a control.PHASE IV: it must be carried out after the placing of the drug on the market to verify its effects on large numbers of patients.
VEGF (vascular endothelial growth factor). It was first introduced in the United States in February 2004 and in Europe a year later for first-line treatment of metastatic colorectal cancer patients. A second class of drugs which include sorafenib and sumtimb, is made up of smaller molecules than the first ones which intervene inside the cell, acting as a block in the formation of particular proteins called "tyrosine kinases". They can also be taken as exclusive care and by mouth, allowing to have less toxic reactions. Approved in Italy All the most important tumors can find help from the anti-angiogenic approach, but the introduction of single preparations in the treatment of particular types of tumors is subject to long and complex experimentation phases. Bevacizumab, for example, is currently approved and already used in Italy for colorectal cancer and metastatic breast cancer and in the first-line treatment of some types of lung cancer Its introduction in Europe as a first-line treatment in cancer patients dates back only to December 2007 advanced renal. The Avoren study demonstrated that for the latter type of tumors an improvement can also be recorded in the general survival of the patients. Sunitinib and sorafenib have been approved for the treatment of kidney cancers. The first was also introduced for Gist*, gastrointestinal stromal tumors, which are very rare but sensitive to new biological drugs. For sorafenib there are very important studies presented this year by the American society of clinical oncology, in Chicago which have demonstrated a beneficial action for liver tumors. Both drugs are taken by mouth, alone or in combination with chemotherapy. Thalidomide, a drug that has made a comeback after being withdrawn from the market, has instead been approved, along with its derivatives, for the treatment of multiple myeloma (see also box below). In the near future These are the antiangiogenic drugs already used in Italy today, while others are still being tested, but almost ready to make their official entry. The best short-term results are expected for enzastaurin and vandetanib. For the first, a drug that can also be taken orally, the trials are aimed at verifying its beneficial action against brain tumours. Research is active in the United States and in Italy at the Veneto Oncological Institute of Padua. On the other hand, the effect on lung cancer is being studied. This drug acts as a brake on both angiogenesis and the proliferation of the tumor cells themselves. Even if they are generally less toxic than chemotherapy drugs, it is always good to remember that patients who are treated with anti-angiogenic drugs can incur some side effects, such as: • high blood pressure, • skin reactions. The
