Out-licensing

Development of AVR118: A Novel Peptide Nucleic Acid with Novel Immunomodulating Activity

Introduction/Background

AVR118 represents a biopolymer that possesses novel immunomodulatory activity. This peptide-nucleic acid complex, which to date has demonstrated a very favourable safety profile, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus, and to dampen aberrant autoimmune-type inflammatory responses, such as those which occur in patients with rheumatoid arthritis.

Aims/Hypothesis

Advanced Viral is currently conducting clinical studies on the novel drug AVR118.

Research

Based on recent work conducted by Advanced Viral Research, new insight has been made regarding the chemical composition of AVR118. As a result of these findings, clinicians will have a better understanding of how AVR118 exerts its clinical effects, whether it is administered topically or systemically. Additionally, this work may provide clues on how new formulations of AVR118 may be produced with greater activity in a variety of different clinical applications.

A new Phase II open label study at McGill University will explore the effect of an AVR118 on patients with recurrent or advanced cancer. Researchers indicate the treatment may help patients who suffer from severe appetite loss, fatigue and weight loss when undergoing aggressive cancer therapy. The Phase II open label study will examine the effect of a 4.0 mL subcutaneous dose of AVR118 on weight, appetite, performance status, and other measures of quality of life in patients with recurrent or advanced malignancies. AVR118 will be administered daily for a trial period of 28 days. Patients who appear to benefit from the trial period dosing will be eligible to continue on AVR118, generating longer term efficacy data. AVR118 may offer a new treatment paradigm in palliative care. Early identification and treatment of patients will hopefully enable us to reduce the severely debilitating effects of cachexia and chemotherapy.

The Phase I/II clinical trial of AVR118 in AIDS patients, which was conducted in Israel, concluded that AVR118 continues to demonstrate evidence of unique patient benefits, a favourable safety profile, and no apparent drug-related adverse events. Unique patient benefits included weight gain, mood improvement, decrease in fatigue, and increase in ability to perform everyday tasks.

A Phase I, double blind, placebo controlled, randomised, single centre, safety study is being conducted with AVR118 in type 2 diabetic subjects in the US. Approximately 30 patients are expected to be entered in the study. The primary objective of this study is to explore the effect of 4.0 ml AVR118 given subcutaneously on blood glucose in subjects with type 2 diabetes who are on sulphonylureas and/or metformin, as compared to subjects not receiving AVR118. Sulphonylureas and metformin are commonly used drugs to control type 2 diabetes. Additional objectives of this study are to explore the mechanism of action of AVR118 in potentially decreasing blood glucose in patients with type 2 diabetes and to explore the effect, if any, of AVR118 on other blood parameters associated with type 2 diabetes. Currently, patients with diabetes are excluded from ADVRs studies. This Phase 1 study is designed to demonstrate whether there is any effect of AVR118 on glucose levels of patients with type 2 diabetes. Advanced Viral Research Corp. has announced that following an interim analysis of 30 patients treated with a 4.0ml dose of AVR118, as well as an additional 3 patients treated with a 1.0ml dose, the company is satisfied in concluding that AVR 118 can be given safely to patients with Type 2 diabetes. Contrary to previous reports, AVR118 had no apparent effects on blood glucose levels in patients receiving oral hypoglycaemic therapies. Moreover, AVR118 had no demonstrable effect on blood chemistry, haematology, weight gain or lean body mass. These findings reinforce the belief that AVR 118 is extremely well tolerated and has no apparent effect on glucose metabolism.

Advanced Viral Research announced that preliminary findings from its ongoing Phase II dermatological study show topical treatment with AVR118 appears to have clinical activity in reducing inflammation and redness associated with surgical incisions or dermatologic dermabrasion. The Phase II open label dermatological study is evaluating the activity of a topically applied spray formulation of AVR 118 as an anti-inflammatory and regenerative healing agent. The first cohort of patients examined underwent dermabrasion for the treatment of severe acne. Following the procedure, AVR118 was applied directly to one half of the inflamed facial tissue. The other half of the face remained untreated. A preliminary examination of five patients demonstrated visible improvement on the treated side of their face. The treated area showed less inflammation as well as a reduction in the redness and swelling of acne lesions. The second cohort of patients examined underwent plastic surgery that resulted in a minimum of two bilateral surgical incisions. AVR118 was applied topically to one wound and the second wound served as an untreated control. In early results from two patients, one patient demonstrated a decrease in inflammation on the treated side.

Conclusion

AVR118 is currently undergoing clinical development as a biopolymer that possesses novel immunomodulatory activity.

Relevance/Opportunity

US Patent No. 6,921,542 has been granted. The Company is currently targeting therapeutic uses of AVR118 that may allow the Company to take advantage of FDA programmes for accelerated drug approvals. Please enquire regarding licensing or codevelopment partnerships.

Phase II

US Patent No. 6,921,542