Bio-Path Holdings, Inc., (BPTH) stock price increased by a staggering 13.99% after it announced the successful completion the safety run-in of Stage 2 of Phase 2 of its clinical study today, for the treatment of acute myeloid leukemia (AML). The safety run-in of Stage 2 of Phase 2 clinical trial consisted of six people effected with AML, who were evaluated and treated with a combination drugs providing a clean side effect profile and no toxicity.
The efficacy signals in the data set also gave encouraging news about the treatment with five of six diagnosed AML patients showing clinical activity.
The Phase 2 clinical trial currently consists of 21 patients present among all three groups. Accommodation of 19 patients in each group would provide an adequate analysis for comparative efficacy review compared with decitabine and venetoclax combination therapy. A positive efficacy result may mean an accelerated approval rate by FDA, with phase 2 of the trials being performed at up to 10 clinical sites.
Corporate Bio-Path Holdings, Inc Highlights
BPTH gained $13.0 Million from a Public Offering, consisting of 1,710,600 shares of common stock which was shared to the public for $7.60, Bio-path gaining a staggering $13M as financial surplus, before subtracting the fees and expense payable by the biotechnology company.
Bio-Path also reported that their product was officially patented and given the title, “P-ethoxy nucleic acids for liposomal formulation.” The new patent protects the platform technology of the nanoparticle drug and gives all rights to BPTH for production.
If BPTH can deliver a drug enhancing the treatment of acute myeloid leukemia (AML), BPTH stock could have a serious capital gain. If the company has halted trials, BPTH shares could have an incredible plummet. Hence the clinical trials play a significant role in deciding the future valuation of the company.