Feb 14 2007, 8:00 AM EST
MARKETWIRE
Royalmount Pharma, an emerging pharmaceutical company, is pleased to announce that the U.S. National Cancer Institute ("NCI") has initiated a clinical trial to assess the tolerability, target tissue levels, biological markers of activity, and pharmacodynamics of RM1812 in colorectal cancer patients.
This single center study will be carried out at the University of Leicester, Leicester Royal Infirmary, Leicester, UK. A total of twenty patients will be enrolled on two dose levels, with ten patients per dose level. Eligible participants in this study are patients with colorectal cancer who will be undergoing a colorectal endoscopy. Patients with biopsy samples positive for adenocarcioma of the colon, which requires surgical resection, will be treated with RM1812 for eight consecutive days prior to a colectomy. Samples from malignant and non-malignant tissue will be analyzed for biomarkers and compared to pre-dose endoscopy results.
"It is now widely accepted that the study of biological markers is important to better understand the activity of a drug and we believe that the results will assist us in the design of our future clinical trials for colorectal cancer chemoprevention and other therapeutic indications," said Dr. Tristan Booth, Chief Scientific Officer of Royalmount Pharma. "Endpoints to measured in this study include levels of M1G adducts by immunoslot blot analysis, levels of COX-2 protein by immunohistochemistry and Ki67 labelling index. We will test the hypothesis that tissue levels of M1G adducts and COX-2 protein will be decreased and Ki 67 labeling index will be reduced following treatment with RM1812."
Royalmount Pharma is collaborating with the NCI under a Clinical Trial Agreement for the evaluation of RM1812 as a cancer chemopreventive agent against colorectal cancer. Chemoprevention is defined as the employment of drugs or natural compounds to prevent the development of benign or malignant tumours. A recently announced, Phase I repeat-dose clinical study to assess the safety and pharmacokinetics of RM1812 following 29-day dosing to healthy volunteers is ongoing.
About Colorectal Cancer
Colorectal cancer is the third most common cancer in the U.S with about 106,680 new cases of colon cancer and 41,930 new cases of rectal cancer in 2006 causing about 55,170 deaths. Risk factors include age, a diet rich in fat and cholesterol, inflammatory bowel disease (especially ulcerative colitis), and genetic predisposition, including hereditary polyposis and nonpolyposis syndromes. The high mortality of colorectal cancer is mainly due to the fact that patients present with advanced disease, thus making the case for preventive strategies. The current standard of care to prevent colorectal cancer is screening in average-risk people, beginning at the age of 50, through annual fecal occult blood testing, flexible sigmoidoscopy and colonoscopy.
About RM1812
The clinical utility of RM1812 is being investigated in several patented indications. The compound has been successfully evaluated in oral single-dose Phase I clinical trials in a total of ninety subjects, demonstrating a good safety profile of the drug in humans. In addition, RM1812 has completed a multi-center Phase IIa clinical trial of a topical formulation for the treatment of recurrent herpes simplex labialis (also known as cold sores). The company is currently seeking a development and commercialization partner.
About the National Cancer Institute
The National Cancer Institute, an agency of the National Institutes of Health (NIH), is the U.S. Federal Government's principal agency for cancer research and training.
About Royalmount Pharma
Royalmount Pharma is an emerging pha
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