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HedgePath Pharmaceuticals Announces Positive Interim Data in its Phase II(b) Cancer Trial ; 13 Subjects with Basal Cell Carcinoma Nevus Syndrome Who Had 167 Surgically Eligible Target Tumors Complete 16 Weeks Dosing

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OTCQB:HPPI

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Additional Relevant Details The data reported today are derived from HPPI’s interim analysis of results in 13 subjects who have completed 16 weeks of SUBA-Itraconazole dosing. Each of these subjects was enrolled in the trial with a requirement that they exhibited significant basal cell carcinoma (BCC) target tumors at baseline consisting of a minimum of 10 surgically eligible lesions, and that they had a history of surgical removal of at least 10 BCC tumors. For each subject, 10 to 15 of the largest lesions are selected by the investigator at baseline to represent a valid sample of overall lesions. HPPI has conducted two separate interim analyses: (i) the change in target tumor burden for each subject (which is based on the sum of the longest diameters for each subject’s target lesions) to measure the change in target tumor burden from baseline; and (ii) the change in the longest diameter of all target lesions for all subjects in the study, which the company believes documents clinical impact, since the disappearance or reduction in size of individual tumors can delay or eliminate the need for surgical procedures that can lead to disfigurement. With respect to target tumor burden, among those subjects who have now been dosed for at least 16 weeks, the target tumor burden has not increased in any subject and has been reduced by greater than 30% in 8 of the 13 subjects (62%) with an average reduction of 60%. In addition, HPPI’s dosing regimen continues to be well tolerated with Grade 1 or no toxicity reported in 90% of subjects assessed to date in the trial, including an additional 6 subjects (total of 19) with 8 or more weeks of dosing. 
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Occurred on:
Aug 03, 2016
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Related Keywords Basal Cell Carcinoma Nevus Syndrome, Gorlin Syndrome