Osta Biotechnologies Inc. Announces Promising Clinical Results

Business Wire, March 14, 2006

MONTREAL -- From its Study Conducted in Collaboration with Helsinki University, Finland, for the Development of a Novel Prognostic Blood Test for Osteoporosis

Osta Biotechnologies Inc. (TSX VENTURE:OBI) today announced promising results of its clinical study for the development of a novel prognostic blood test for risk of osteoporosis involving a total of 234 young Finnish males. This human clinical study was conducted in collaboration with Helsinki University, Finland and shows that alterations in the human Parathyroid Hormone Related Peptide (PTHrP) gene correlate significantly with bone mass in young Finnish males. These genetic alterations discovered by Osta's scientists form the basis of Osta's novel prognostic blood test for osteoporosis. The observed genetic alterations were found to be predictive of who is at risk of developing low bone mass & osteoporosis and who might develop high bone mass in the male population in Finland. These findings make a very important contribution to Osta's plan to develop a novel blood test for assessing the risk of developing low bone mass and osteoporosis and provide an important advancement towards generating sufficient clinical data in order for the company to enter into co-development/commercialization agreements with pharmaceutical/diagnostic companies world-wide. This clinical data will be presented by the company at the upcoming International Osteoporosis Foundation (IOF) World Congress on Osteoporosis meeting to be held in Toronto, Canada from June 2-6, 2006.

Results of the Clinical Study

In this study, the association between a Parathyroid Hormone Related Peptide (PTHrP) variable number of tandem repeats (VNTR) polymorphism and peak bone mass was examined in 234 young healthy Finnish males. VNTR length was determined by PCR amplification of genomic DNA extracted from white blood cells and its association with bone mineral density of the lumbar spine and hip, and quantitative ultrasound measurements of the calcaneus (the heel bone) was assessed.

The results showed that the presence of at least one 252 base pair (bp) allele was associated with increased skeletal densitometric and ultrasound parameters and the presence of at least one 378 bp allele was associated with decreased densitometric measurements. The correlation with increased bone mass was strengthened by pairing of the 252 bp allele with a 460 bp allele. In contrast, bone mass was reduced by pairing of the 252 bp allele with a 378 bp allele. Consequently, PTHrP VNTR polymorphisms were found to predict either high or low bone mass in young Finnish males. These findings highlight the importance of these PTHrP polymorphisms as diagnostic predictors of risk for low bone mass and osteoporosis in this population.

PTHrP is expressed in the bone-forming cells of the skeleton (osteoblasts) and is critical for their proper proliferation, differentiation, and function, processes that are pivotal for attaining and maintaining appropriate bone mass thereby preventing the development of osteoporosis.

Dr. Matti Valimaki, Professor of Medicine, Division of Endocrinology. Department of Medicine, Helsinki University, Finland and co-author of the study commented "Our findings indicate that particular alleles and combinations of specific PTHrP VNTR alleles correlate with variability in peak bone mass in the Finnish male population and raise the possibility that this genotypic approach may serve as an important tool in identifying individuals with a genetic predisposition to low bone mass acquisition at a relatively young age and hence a higher risk for developing osteopenia and osteoporosis in later life."

Dr. David Goltzman, Osta's Senior Vice-President Research & Development, Chairman of the Scientific & Clinical Advisory Boards and former President of the American Society of Bone & Mineral Research (ASBMR) commented "We are very excited about these results. Our findings provide compelling evidence for the predictive value of the length of the PTHrP VNTR polymorphism in the attainment of peak bone mass in young Finnish males. Clearly, this polymorphism is likely to represent one such potential marker since segregation studies in families with osteoporosis support a pattern of inheritance that is most consistent with the effects of several genes, each with modest effects, rather than a few genes with large effects. It is conceivable that a multi-gene diagnostic sensor chip based on a number of genetic markers including PTHrP as a candidate gene would predictably identify those subjects at risk of developing low bone mass and osteoporosis so that preventive interventions and/or prophylactic therapeutic measures could be instituted early and effectively."

Dr. Ethel S. Siris, Madeline C. Stabile Professor of Clinical Medicine, Columbia University and Director, Toni Stabile Osteoporosis Center, New York-Presbyterian Hospital, New York, New York commented: "A better understanding of the determinants of peak bone mass is critical as we seek to identify individuals who may be at higher risk of late life fractures because of genetically programmed lower levels of peak bone mass. The findings in this clinical study are exciting as they provide solid evidence that PTHrP VNTR polymorphisms play an important role in the attainment of peak bone mass in young Finnish males. This study makes a very important contribution to the evolving science of osteogenetics and to the objective of developing a highly desired prognostic test for assessing the risk of developing low bone mass and osteoporosis."