Avicena Group, Inc. Initiates Novel Creatine Bioequivalencey Study Aimed At Optimizing Therapies

PALO ALTO, Calif., May 2 /PRNewswire-FirstCall/ -- The Avicena Group, Inc. (Avicena), a developer of novel pharmaceutical and therapeutic products, announced today that it has initiated patient dosing for an innovative research study aimed at comparing the bioavailability of creatine monohydrate and creatine ascorbate. Researchers at McMaster University Medical Centre will seek to determine which formulation is best suited for increasing muscle and brain levels of creatine, a key consideration used in determining proper patient dosing and treatment administration. The study's findings may directly impact the treatment of a number of diseases that currently benefit from creatine supplementation, including creatine transporter defect (CTD), muscular dystrophy and mitochondrial disorders.

"While creatine monohydrate has been shown to be useful as an adjunct treatment for certain disorders, it does have minor limitations including limited solubility in water," stated Mark A. Tarnopolsky, M.D., Ph.D., F.R.C.P.(C), Professor, Departments of Pediatrics and Medicine, McMaster University and the study's lead investigator. "By comparing the bioavailabilty of creatine ascorbate, we will determine whether this formulation allows for greater absorption into the blood stream and better solubility than creatine monohydrate. Additionally, we will determine whether the inclusion of ascorbate (vitamin C), as a creatine ascorbate formulation may provide the added therapeutic benefits associated with antioxidants."

Study investigators will enroll a total of 30 healthy patients in this randomized bioequivalency trial, assigning them to one of three treatment arms (creatine ascorbate/placebo, creatine monohydrate/placebo or ascorbate/placebo). Throughout the course of the study, which includes a four-week dosing phase followed by a five-week "wash-out" period, researchers will monitor a number of key clinical measures, including levels of creatine found in patients' blood, muscle and urine.

"This is an important study for Avicena as it will provide critical information for the optimization of a number of our drug candidates, including CTD-09, our proprietary pharmaceutical for the treatment of creatine transporter defect," said Belinda Tsao-Nivaggioli, Ph.D., Avicena's chief executive officer. "The potential enhancement of these pharmaceuticals through lower dosing regimens and improved administration will assist us in developing and delivering superior therapies to a number of patient populations that presently lack effective therapeutic options."

Avicena expects the findings from this trial to assist the company in its ongoing work related to CTD. The company is currently conducting a Phase I trial of CTD-02 at the University of Cincinnati and Cincinnati Children's Hospital Medical Center and plans to initiate a dose-escalation study of CTD-09 in collaboration with these same researchers.

About CTD

Identified in 2001 through pioneering research conducted at the University of Cincinnati and Cincinnati Children's Hospital Medical Center, X-linked CTD is an inherited error of metabolism that inhibits the body's ability to supply sufficient levels of creatine to the brain via the creatine transporter. Caused by a defect in the X-linked creatine transporter, CTD results in mental retardation with symptoms including speech and language impairment, short attention span, and low IQ. Due to the fact that CTD has only recently been identified, the true incidence rate of the disease is not known and there is presently no known cure.

CTD has been shown to affect both males and females. However, the severity of the mental retardation is significantly magnified in male patients due to the fact that the defect is located on the X-chromosome, of which males have only one. Female CTD carriers (mothers and sisters of male CTD patients) appear to have only partial function of the transporters and as a result, can suffer from lower cognitive function than the general population, but higher than male CTD patients. Due to these differences, treatment of CTD will differ between genders.

About Avicena

Based in Palo Alto, CA, Avicena is a biotechnology company that seeks to develop and commercialize therapeutic products that regulate the critical energy processes which occur within human cells. Avicena's focus is on the development of pharmaceutical products to treat patients with rare diseases (orphan drugs), as well as dermaceutical and nutraceutical products. To date, the company has advanced certain compounds for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) into Phase III trials and treatments for Huntington's disease (HD) into Phase II development. Having completed Phase II trials, the company is now considering a Phase III trial for the treatment of Parkinson's disease.


This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management's current expectations, plans and strategies, and anticipated financial results, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict. See "Risk Factors" in the company's prospectus and annual report for a discussion of such risks, including the company's need for additional funds, the company's dependence on a limited number of therapeutic compounds, the early state of the products the company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the company's ability to avoid infringement of the patent rights of others, and the company's ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. Avicena does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.

Contact: Vida Communication (on behalf of the Avicena Group) Stephanie Diaz (investors) Tim Brons (media) 415-675-7400 415-675-7400 sdiaz@vidacommunication.com 646-319-8981 (mobile) tbrons@vidacommunication.com

The Avicena Group, Inc.

CONTACT: investors, Stephanie Diaz, +1-415-675-7400, orsdiaz@vidacommunication.com, or media, Tim Brons, +1-415-675-7400, ormobile, +1-646-319-8981, or tbrons@vidacommunication.com, both for TheAvicena Group, Inc.

Back to news