Early data from the ongoing Phase II clinical trial for first-line treatment of colorectal cancer patients confirmed that 43% of evaluable patients have significant tumor shrinkage. In addition, none of the patients experienced hematological or gastrointestinal SAEs, grade 3 or higher.
The company tracked these patients and gathered data after they left the trial. The patients entered the trial with disease that progressed despite previously being treated with standard chemotherapies and biologics such as Avastin or Erbitux. Two patients survived more than two years and one patient is alive today. The interim data is for 14 of 20 patients who were enrolled in the trial. The company is in the process of gathering data on the other six patients.
The data also revealed a significantly reduced level of toxicity as measured by serious adverse events (SAEs). Additionally, the data showed no apparent change from the baseline measurements in any clinical parameter including platelets and white blood cell counts. Safety data indicates improved quality of life.
David Platt, CEO of Pro-Pharmaceuticals, said: “This is the first time a polysaccharide used in colorectal cancer patients has demonstrated a dramatic improvement in safety and efficacy.”