Origin and Development
Bortezomib was originally synthesized in 1995 (MG-341) at a company called Myogenics, which soon changed its name to ProScript. After promising preclinical results, the drug (PS-341) was tested in a small Phase I clinical trial on patients with multiple myeloma cancer. ProScript ran out of money and was bought by Leukosite in May 1999. Leukosite in turn was bought by Millennium Pharmaceuticals in October 1999. At this point in time, the project had low priority amongst other projects at the company. This changed significantly when one of the first volunteers to receive the drug in the clinical trial achieved a complete response and were still alive four years later. At the time this was a remarkable result. Later clinical experimentation indicates the possibility of a complete response in 15% of patients in a similar condition, when treated with bortezomib. In May 2003, seven years after the initial synthesis, bortezomib (Velcade) was approved in the United States by the Food and Drug Administration (FDA) for use in multiple myeloma, based on the results from the SUMMIT Phase II trial. Another commercially available bortezomib product - Bortenat (Natco Pharma, India), reportedly contains substantially more active entity than declared, potentially and even more resulting in increase toxicity. Moreover, Bortenat has some other chemical and formulation deviations from the registered ethic product Velcade (Millennium Pharmaceuticals and Janssen-Cilag), with unclear clinical impact.
Read more about this topic: Bortezomib
Famous quotes containing the words origin and, origin and/or development:
“We have got rid of the fetish of the divine right of kings, and that slavery is of divine origin and authority. But the divine right of property has taken its place. The tendency plainly is towards ... “a government of the rich, by the rich, and for the rich.””
—Rutherford Birchard Hayes (1822–1893)
“The real, then, is that which, sooner or later, information and reasoning would finally result in, and which is therefore independent of the vagaries of me and you. Thus, the very origin of the conception of reality shows that this conception essentially involves the notion of a COMMUNITY, without definite limits, and capable of a definite increase of knowledge.”
—Charles Sanders Peirce (1839–1914)
“As long as fathers rule but do not nurture, as long as mothers nurture but do not rule, the conditions favoring the development of father-daughter incest will prevail.”
—Judith Lewis Herman (b. 1942)