Allon Granted Important U.S. Patent for Preclinical Compound AL-408

Allon Therapeutics Inc. has announced that it has been granted an important United States patent covering the composition of matter for the D-isomer of NAP (davunetide). The D-isomer of davunetide is known as AL-408 in the company's pipeline.

This new patent strengthens Allon's intellectual property estate which includes 15 patent families, 58 issued patents and over 30 pending applications worldwide.

Previous pre-clinical studies have demonstrated that AL-408 shows potent neuroprotective effects in a number of in vitro and in vivo models of neurotoxicity. In an animal model of fetal alcohol syndrome, AL-408 increased survival and improved cognitive performance.

AL-408 has also shown potential neuroprotective activity in a preclinical model of amyotrophic lateral sclerosis (ALS).

Dr. Alistair Stewart, Allon's Vice President of Commercial Research, said this new U.S. patent provides protection for an important early-stage compound within the Company's product pipeline.

"Allon's technology platform of neuroprotective peptides derived from naturally occurring brain proteins shows broad neuroprotective effects in a variety of diseases and conditions," explains Stewart.

Stewart continued, "AL-408 has shown some interesting early-stage research results in areas outside of neurodegenerative diseases, further diversifying and adding value to our product pipeline."

Allon's patent portfolio also includes issued patents and pending patent applications that provide protection around davunetide and its technology platform for treatment of neurodegenerative diseases, including progressive supranuclear palsy (PSP), Alzheimer's disease, and Parkinson's disease.

On August 12, 2011, the Company announced it had enrolled approximately 75% of the 300 patients specified in the protocol designed to assess efficacy and safety of davunetide (AL-108) in PSP patients. Enrollment began in the fourth quarter of 2010.

The trial is being conducted under a Special Protocol Assessment (SPA) granted by the United States Food and Drug Administration (FDA), which ensures that the agreed clinical trial design meets the FDA's expectations for a pivotal study.

This multi-national study is being conducted at leading medical institutions in the United States, Canada, the United Kingdom, France, Germany, and Australia. Details can be found at clinical trials.gov.

The patent granted by the United States Patent and Trademark Office covers the composition of matter for AL-408 that has the same amino acid sequence as davunetide but contains all D-amino acid isomers. Davunetide contains all L-isomers.