Cell Therapeutics a biotechnology firm based in Seattle has called off further enrollment for the clinical trial it had initiated early this year following the untimely deaths of few of the patients who were participating in the clinical trial to prove the efficacy of the cancer drug Xyotax.
The CEO of the company James Bianco has reiterated that the deaths of the volunteer s who were cancer patients do not seem to have been triggered of by any kind of toxic effect of the drug Xyotax. He declined to divulge how many patients had actually succumbed to death after the clinical tests were initiated .However he did admit that more women have died from lung cancer in the group that were being given the drug than the group that were put on a standard chemotherapy drug.The deaths have been certified to have been caused simply because of progression of the lung cancer. Most of the patients participating suffered from advanced cancer. The probability of the clinical tests progressing now is bleak until the data relating to present deaths are studied which would be anything more than six months. This could mean severe financial setbacks for the company.
This clinical trial which had been termed as Pioneer was unique in having enrolled only women who were suffering from lung cancer. It was publicized in a big way with enrollment made at 170 medical centers globally last April, and had planned to study about 600 patients to prove the efficacy of Xyotax in increasing the life span of patients with lung cancer using a regularly used chemotherapy agent coupled with a polymer which is supposed to help in making the it more user friendly.
The same drug in previous tests conducted last year failed to prove itself in improving survival rates in general but showed significant benefits among women. The company has announced that once the study resumes women normal estrogen levels who had already enrolled would be welcome to benefit from trials with Xyotax.
Incidentally this company had conducted a similar trial way back in 2003 when it was prematurely halted when deaths of patients were reported with a sudden fall of white blood cells in their bodies owing to drug toxicity. This time around the drug dosage and concentration was severely tapered to avoid toxicity.
Source-Medindia
MST
