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news.US-based biotechnology firm Bio-Path Holdings has completed cohort six of its Phase I clinical trial evaluating lead compound, Liposomal Grb-2, in blood cancers.
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In this cohort, three patients were evaluated and they showed that Liposomal Grb-2 is safe and well tolerated with the drug showing signs of anti-leukemia activity.
The Phase I clinical trial included a total of 34 patients, of which 21 were evaluable and it evaluated escalating doses of Liposomal Grb-2 (5, 10, 20, 40, 60 and 90mg/m2).
During the trial, patients were treated twice a week for four weeks, for a total of eight doses.
The company is now completing an analysis of the Phase I data to submit to the US Food and Drug Administration (FDA). The company said that as a result of the safety profile of the drug, a maximum tolerated dose has yet to be reached.
Bio-Path president and chief executive officer Peter Nielsen said: "We will now move this program into Phase II while also extending the Phase I portion to continue testing higher doses since we have not yet reached a maximum tolerated dose."
The company expects to begin Phase II clinical trials by the end of 2014.