Avicena And University Of Cincinnati Announce Defective Creatine Transporter Gene Present In Autistic Patients

Main Category: Autism
Also Included In: Genetics;  Neurology / Neuroscience
Article Date: 09 May 2007 - 0:00 PDT

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Avicena(R) Group, Inc. (OTC Bulletin Board: AVGOE), a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today that Dr. Amy Newmeyer, M.D., of the University of Cincinnati, will present results indicating that the defective creatine transporter gene (SLC6A8) is present in autistic patients. The results of this screening study will be presented at the Academic Society's Annual Pediatric Neurology Meeting in Toronto today.

Defects in the creatine transporter gene (SLC6A8) have been linked to mental retardation and certain learning disabilities typically characteristic of autistic patients. The screening study, which was conducted among 100 male autism spectrum disorder patients aged three to 18 years of age, revealed a 1% incidence rate of the defective SLC6A8 gene.

"These results are in line with previous studies which showed an up to 2.1% incidence rate of the defective Creatine Transporter gene amongst X- linked mental retardation." stated Belinda Tsao-Nivaggioli, Chief Executive Officer of Avicena. "At this level, Creatine Transporter Defect (CTD) is the second most common cause of X-linked mental retardation."

Avicena, in collaboration with Dr. Ton DeGrauw of the Cincinnati Children's Hospital Medical Center and Dr. Joe Clark of the University of Cincinnati Medical Center are already developing a model that will allow for the rapid screening of carriers and patients who exhibit the general characteristics associated with CTD.

"We have made significant progress since discovering this genetic defect in 2001," said Dr. Joe Clark. Avicena, in collaboration with the University of Cincinnati and Cincinnati Children's Hospital, is developing potential therapies for the treatment of CTD. Further, the development of a screening model will allow us to rapidly and more broadly screen not only patients that exhibit mental retardation, but also the incidence of CTD in other areas including developmental delay conditions, learning disabilities and neurodegenerative diseases. This may result in a significantly higher incidence rate of CTD in a broad spectrum of neurological disorders.

ABOUT THE SCREENING

One hundred male subjects aged three to 18 years with a diagnosis of autism spectrum disorder or a non specified pervasive developmental disorder (PDD-NOS) based on DSM-IV criteria were either recruited from the Cincinnati Children's Hospital Medical Center or identified from the Autism Genetic Response Exchange database. All subjects were administered the ADOS (autism diagnostic observation schedule) to confirm the presence of autism or PDD-NOS. Blood samples were obtained from all subjects for a DNA sequence analysis to identify defects in the creatine transporter gene (SLC6A8). Urine and blood samples were also obtained from patients and analyzed for Creatine and guadinoacetate levels.

ABOUT CREATINE TRANSPORT DEFECT (CTD)

Creatine Transporter Defect, an X-linked, inherited error of metabolism, was identified in 2001 in collaboration between Avicena and researchers at the University of Cincinnati and Cincinnati Children's Hospital Medical Center. CTD prevents the successful transport of sufficient levels of creatine across the blood brain barrier via the creatine transporter. Patients may suffer from autistic like symptoms as well as moderate to severe speech and language impairment, short attention span, and low IQ. 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. CTD is presently diagnosed using either magnetic resonance imaging (MRI) examination or through DNA analysis.

ABOUT AVICENA

Avicena Group, Inc. is a late stage biotechnology company focused on developing products based on its proprietary understanding of the regulation of cellular energy processes. The company's core technologies, supported by a robust IP portfolio, have broad applications in both pharmaceuticals and dermaceuticals. Avicena's pharmaceutical program centers on rare neurological disorders (orphan diseases). The company is currently analyzing survival data from its Phase IIb/III trial in ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease). Near term, Avicena intends to initiate a Phase III trial in Huntington's disease to accompany its on-going Phase III trial in Parkinson's disease. Avicena's science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena's clinical programs are largely funded by government and non-profit organizations. Avicena presently derives revenue from the sale of proprietary ingredients to skin care manufacturers.

SAFE HARBOR

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" under "Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operation" from our Annual Report on Form 10-KSB for the year ended December 31, 2005, and other descriptions in the company's public filings with the Securities and Exchange Commission 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 stage 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.

Avicena Group, Inc.
http://www.avicenagroup.com

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