Pro-Pharmaceuticals (PRW) Reports Positive Phase II Data of DAVANAT in Combination with 5-fluorouracil
Pro-Pharmaceuticals, Inc. (Amex: PRW) announced that data of all end-stage colorectal cancer patients from its Phase II trial showed DAVANAT, administered in combination with 5-fluorouracil (5-FU), extended median survival by 6.7 months or 29 weeks after all other treatments were exhausted. The data for the 20 patients that completed the trial revealed that three patients survived more than one year, two patients survived more than two years and one patient is still alive.
The data also revealed significantly reduced levels of toxicity as measured by serious adverse events (SAEs). The patients from the Phase II trial experienced total SAEs of 35% with only 10% drug related, compared with more than 70% SAEs reported for similar patient populations in similar trials. Additionally, the data showed no apparent change from the baseline measurements in all clinical parameters including platelets and white blood cell counts. Safety data indicates improved quality of life.
The data also revealed significantly reduced levels of toxicity as measured by serious adverse events (SAEs). The patients from the Phase II trial experienced total SAEs of 35% with only 10% drug related, compared with more than 70% SAEs reported for similar patient populations in similar trials. Additionally, the data showed no apparent change from the baseline measurements in all clinical parameters including platelets and white blood cell counts. Safety data indicates improved quality of life.
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