Biotechs clinical trials

A number of rationally designed MMP inhibitors have shown some promise in the treatment of pathologies, which MMPs are suspected to be involved in. However, most of these, such as Marimastat (BB-2516), a broad spectrum MMP inhibitor, or trocade (Ro 32-3555), an MMP-1 selective inhibitor, have performed poorly in clinical trials. The failure of Marimastat was partially responsible for the folding of British Biotech, which developed it. The failure of... 

Figure 6.8 Chromatographic columns. The glass column illustrated in (a) is manufactured by Merck. A wide variety of columns (ranging in size from 1 ml to several litres, and constructed from glass/plastic or stainless steel) are available from this and a number of other manufacturers (e.g. Bio-Rad and Pharmacia Biotech), (b) Process-scale chromatographic system. This particular system is utilized by a UK-based biotech company in the manufacture of a (protein) drug for clinical trials. The actual column is positioned to the left of picture...

The high degree of skewness in fhe outcomes of pharmaceutical R D projects indicates that there are substantial risks in this endeavor, both for big pharmaceutical firms as well as smaller biotech enterprises. This reflects the dynamic nature of the R D process, the long time periods from the start of a project to market approval, the unpredictability of clinical trials, as well as regulatory and competitive xmcertainties. 

Of every 5000 medicines tested, on average, only 5 are tested in clinical trials and only 1 of those is approved for patient use." Very, very few biotech concepts yield commercial returns. Consequently, investors are hypersensitive to events which appear to shift the odds of success one way or the other. What drives biotech stock prices up or down is not changes in timelines, but rather changes in perceptions of the risk of failure. 

Rogoski R. Technology, clinical trials drive up drug development costs. In Depth Biotech J From the January 16, 2004 print edition. 

Agrawal, S. (1996) Antisense oligonucleotides towards clinical trial. Trends Biotech., 14, 376-387. 

At present, between one-third and one-half of potential biotech drugs in human clinical trials or under development are mAbs. 

However, therapeutic antibodies to selectively expressed, genomics-or proteomics-provided targets, such as antigens in tumors, enter clinical trials for many cancer forms very rapidly. One makes humanized or human antibodies, by different methods, which either carry something or act on their own. These are safe. They are often efficacious. But they are difficult to administer you have to inject them. They work in small indications, and they are perfect for small companies. The first Biotech company to make money in San Diego, IDEC Pharmaceuticals, did just this quite successfully, well enough later to buy Biogen and move to Boston in 2003. 

To smooth out the bumps, curves, and reversals, each Big Pharma has 30 to 40 clinical trials ongoing all the time. So losing one is sad for the team that worked on it, but they can come back tomorrow to start on a new project. In Biotech the ups and downs are a real drama watched by investors and employees with the same anxiety ... 

Biotechnology Information Directory. Cato Research. URL http //www.cato.com/biotech/. Information sources, publications, products, services, software, companies, clinical trials, regulatory affairs, education, employment, RSS feed. 

---