Showing posts with label clinical studies. Show all posts
Showing posts with label clinical studies. Show all posts

Saturday, June 2, 2012

A trial looking at curcumin and FOLFOX for advanced bowel cancer (CUFOX)

In continuation of  my update on curcumin
An upcoming clinical trial conducted by the Cancer Research UK and National Institute for Health Research Experimental Cancer Medicine Centre (ECMC) in Leicester, England will evaluate the effectiveness of curcumin, a compound that occurs in turmeric, as a means of improving the results of standard chemotherapy for metastatic colon cancer. The compound has been found to enhance chemotherapy's ability to kill colon cancer cells in previous research involving cell cultures. 

Doctors often treat bowel cancer that has spread with chemotherapy. The combination of chemotherapy they usually use is called FOLFOX. It is made up of the drugs folinic acid (leucovorin), fluorouracil (5FU) and oxaliplatin. But this doesn’t always work very well.  And it often causes side-effects such as numbness and tingling in hands and feet (peripheral neuropathy). This means the doctors sometimes need to lower the dose or even stop chemotherapy, so they are keen to improve treatment.

Curcumin is a plant extract found in the spice turmeric and is found in many everyday foods. We know from research that curcumin can help shrink tumours in the laboratory. It has also been used in several studies involving patients with a range of conditions, including cancer.

Wednesday, May 30, 2012

Positive Results from First of Two ATX-101 European Phase III Trials for Reduction of Submental Fat

KYTHERA,  announced the presentation of initial trial results from Study ATX-101-10-16, the first of two pivotal European Phase III clinical trials with ATX-101 (a first-in-class injectable drug being studied for the reduction of localized fat. ATX-101 is a proprietary formulation of deoxycholate (see below structure)  a well-studied endogenous compound that is present in the body), a facial injectable drug for the reduction of unwanted fat under the chin, or submental fat. V. Leroy Young, MD, FACS, presented the initial results at the American Society for Aesthetic Plastic Surgery (ASAPS) 45th Annual Aesthetic Meeting in Vancouver, British Columbia, on May 4, 2012.

The ATX-101-10-16  trial met its pre-specified primary endpoints based on clinician and patient assessments. At the 2 mg/cm2 dose, ATX-101 resulted in a statistically significant reduction of submental fat, relative to placebo, as measured using a 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (mean of 0.90 vs. 0.22; p<0.001, week 24). Similarly, ATX-101 (2 mg/cm2) resulted in a statistically significant percentage of subjects, relative to placebo, achieving a pre-defined categorical change using a 7-point Subject Self Rating Scale (SSRS) (66.1 vs. 28.7; p<0.001, week 24).

Sunday, February 12, 2012

Erivedge Approved to Treat Basal Cell Carinoma

Erivedge(vismodegib) has been approved by the U.S. Food and Drug Administration to treat the most common form of skin cancer, basal cell carcinoma, the agency said Monday.
The drug was approved for people for whom surgery or radiation aren't options, and for people with basal cell that has spread to other parts of the body, according to an FDA news release. Erivedge was evaluated in clinical studies involving 96 people with basal cell carcinoma. The most common side effects included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted taste, loss of appetite and constipation.
The drug was approved with an FDA's label warning that pregnant women who take Erivedge could have babies at greater risk of severe birth defects or death. "Pregnancy status must be verified prior to the start of Erivedge treatment," the agency release advised.