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Factor Therapeutics Limited (ASX:FTT) has its lead program called âVF001â that has been developed for the treatment of ulcers. The lead program VF001 is currently in stage 2. On November 14, 2018, FTT presented the results from the clinical trial conducted for Phase 2, VF001012, for the treatment of venous leg ulcers (VLU).Â
Phase 2 study, commonly termed as placebo âcontrolled multicenter study was done to evaluate the application of the study drug VF001 which was applied for a duration of 12 weeks on patients suffering with VLUs. Approximately 157 patients, across 21 sites were taken into consideration under this study who were given either low dose of 28 micrograms per mL of VF001 or a high a dose of 280 micrograms mL of VF001 along with placebo and the standard care. The treatment was applied in the ratio of 1:1:1 which means either placebo + low dose of VF001 +standard care or placebo +high dose of VF001+standard care.
The study to evaluate the addition of VF001 does not come up with positive and effective results. Across all three-healing measures studied under this study, right from evaluation of the wound size reduction, number of patients whose ulcers got fully healed to the total time taken to achieve full healing, the results with the addition of VF001 drug failed to provide any additional benefit in comparison to the treatment done by just placebo together with the standard care. Similar kind of safety profiles were displayed by all three study groups.
CEO of Factor Therapeutics Limited, Dr Rosalind Wilson while making an announcement for the clinical trial results discussed the reason for why such study was undertaken by the company and what the outcome of the results means to the companyâs ongoing progress. He further said the sole purpose of undertaking this study was to determine whether VF001 can provide or show some improvement on patients with venous leg ulcers. He said though the trial was well designed and executed, the outcome failed to support the view and there is no clinical justification to continue with the study.
Chairman of the FTT board, Dr Cherrell Hirst, further said that with no clear justification with the study and no satisfying results with the addition of VF001, FTT will cease all developments pertaining to VF001. The disappointing results from the study will not affect the ongoing developments done to VF001 but will limit FTT activity to a considerable extent in order to maintain its existing intellectual property portfolio.
With the announcement of the trial results, FTT opened with a gap down at the levels of $0.002. FTTâs previous day closing levels were at $0. 073.The scrip has shown a free fall and currently trading at the levels of $0.002 (down over 97% on November 14, 2018, 3 PM AEST).
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