AsianScientist (May 30, 2011) – Singapore-based Davos Life Science (DavosLife) announced today preliminary results of a Phase I clinical trial of its Natural e3 delta-tocotrienol (Natural e3) in patients with resectable pancreatic cancer.
Tocotrienols are highly potent members of the vitamin E family that have been found by researchers to inhibit the growth and survival of various types of cancer cells. Natural e3 has achieved GRAS (Generally Regarded As Safe) status by the US Food and Drug Administration (FDA), and may have applications in pancreatic cancer – a highly fatal form of cancer with five year survival rates at less than 10 percent from the time of discovery.
In a study carried out at the H. Lee Moffitt Cancer Center & Research Institute in Florida and supported by Davos Life and the US National Institute of Health, researchers found that Natural e3 was able to increase cell death in pancreatic cancer tumors, with no toxicity. The data was presented at the recent American Association for Cancer Research (AACR) Annual Meeting.
For a period of two weeks prior to surgery, 12 subjects received Natural e3, with three subjects at each dose level of 200 mg, 400 mg, 600 mg, and 800 mg per day. This oral treatment occurred pre-surgery to examine the effect of Natural e3 on the resected pancreatic cancer tumor. To assess for toxicity, blood samples were collected pre-dose on day 1, day 8, the day of the patients’ surgery, and 3-6 weeks post-surgery. This trial occurred between October 2009 and August 2010.
The Moffitt Cancer Center researchers, led by Dr. Mokenge Malafa, Head of Pancreatic Oncology, found no adverse drug-related events in the patients and no change in the rate of post-operative complications at doses up to 800 mg per day. They also found that giving patients daily doses of Natural e3 greater than 200 mg increased apoptosis in the pancreatic tumors as well as increased expression of kinase inhibitor p27. Reduced levels of p27 have been found in some types of cancers.
“We are pleased to be supporting Moffitt’s early Phase clinical trials of Natural e3 for cancer prevention and treatment. DavosLife is supplying all of the Natural e3 as well as part funding for the trials,” said Arthur Ling, CEO of DavosLife.
The Moffit Cancer Center is moving ahead with their Phase I dose escalation trial with the next dose level of 1600 mg per day already in progress. Two Phase I trials of Natural e3 in healthy subjects have also been initiated.
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Source: Davos Life.
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