Development Status

Davunetide intranasal and davunetide intravenous are formulations respectively of the same compound developed from the Company’s Activity Dependent Neuroprotective Protein (ADNP) technology platform.

Allon’s clinical development strategy is direct: Build a strong safety foundation in large conventional Phase I studies and then identify multiple opportunities to define human efficacy Phase II studies. Allon’s current studies are designed to show efficacy and provide valuable data on the best end points and patients for subsequent studies.

Allon’s lead product davunetide intranasal is being evaluated in human clinical trials as a treatment for Alzheimer’s disease, frontotemporal dementia and schizophrenia-related cognitive impairment.

The Company has robust Phase IIa human efficacy data for davunetide intranasal in patients with aMCI and will commence a Phase IIb trial in Alzheimer’s patients with a partner.

In addition, the Company will initiate a Phase II study to examine the effect of davunetide intranasal on human brain metabolism, which declines with progression of AD. Positron emission tomography (PET) scans will be used to image glucose metabolism in the brains of patients with AD, providing a method for evaluating the short-term treatment effects of davunetide intranasal.

Top-line results are expected in 2009 from a Phase II clinical trial evaluating the safety and efficacy of the Company’s proprietary drug candidate davunetide intranasal in patients with schizophrenia-related cognitive impairment. This trial is being funded largely by TURNS (Treatment Units for Research on Neurocognition and Schizophrenia), which is supported by the U.S. National Institute of Mental Health. Enrolment was completed in this study in Q4 ‘08.

The Company will initiate in 2009 a Phase II clinical trial in frontotemporal dementia (FTD). FTD describes several cognitive disorders, such as Pick’s disease, for which no treatment is currently available, including several that are fatal within three to five years of diagnosis. In addition, about 50% of the FTD disorders are tauopathies, or tau-related diseases. Allon’s technology is recognized as the most clinically advanced tau-related therapy.

Davunetide intravenous
Davunetide intravenous is being developed as a second generation Alzheimer’s product. Allon has previously reported that a Phase IIa clinical trial in patients who had undergone coronary artery bypass surgery demonstrated that davunetide intravenous was safe and well-tolerated by patients at a dose 20 times greater than the dose in the davunetide intranasal aMCI trial.

Allon’s technology platforms

Allon's neuroprotective compounds are derived from two technology platforms: Activity-Dependent Neuroprotective Protein (ADNP) and Activity-Dependent Neurotrophic Factor (ADNF). ADNP and ADNF are two classes of proteins that treat or protect neurons against degenerative diseases and injuries.

Both platforms originated from studies on vasoactive intestinal peptide (VIP). VIP is an important neuroprotective peptide. In early studies, VIP was shown to be a broad neuroprotectant, causing the neuroprotective proteins ADNP and ADNF to be secreted from glial cells or brain support cells.