AMAR has three active human clinical development programs for oral interferon.

Influenza

Clinical studies have demonstrated that low doses of intranasal or oral interferon are safe and effective at preventing or treating influenza. In the former Soviet Union, approximately 14,000 people participated in controlled studies of placebo versus interferon treatment during a natural outbreak of Hong Kong influenza. Interferon (about 128 units) or placebo was dripped into the nose daily for 5 days starting about the time of the first reported influenza cases. Interferon treatment significantly reduced the number of influenza cases (P<0.01 for all age groups).

The University of Western Australia received a grant from the Department of Health, Government of Western Australia and in May 2009 started a Phase 2 clinical study of oral interferon as prevention/treatment of respiratory illnesses, including influenza, in Perth, Australia. Two hundred (200) healthy volunteers in Perth Australia were enrolled to take oral IFN or placebo lozenges once daily for 16 weeks.  Once per week, the study volunteers completed a questionnaire detailing the severity of any cold/flu symptoms experienced, any medications taken, number of days of work missed, etc.  The aim of the study was to determine whether the volunteers who took oral IFN would experience fewer respiratory illnesses and/or less severe symptoms during the 2009 winter cold/flu season in Australia.

The study found that volunteers who took oral interferon had a shift from moderate to mild in the severity of cold/flu symptoms, compared to volunteers who received placebo. Significantly fewer volunteers in the interferon group who had been vaccinated against seasonal influenza had an episode of influenza-like illness during the study, compared to vaccinated volunteers in the placebo group. Additionally, volunteers over the age of 50 (high risk for influenza) experienced fewer episodes of influenza-like illness if they took interferon during the study, compared to those who received placebo. Laboratory results regarding viral infection rates during treatment are expected in the second quarter of 2010.

For more information on this study, please visit: http://www.clinicaltrials.gov/ct2/NCT00895947?term=oral+IFN&rank=18

or contact Martin Cummins.

Chronic Cough-COPD

In a pilot study, 5 of 6 patients with idiopathic pulmonary fibrosis (IPF) reported significant relief of their chronic cough after taking oral interferon.  Reduction in cough resulted in better sleep and an improved quality of life for these IPF patients.

Texas Tech University is currently funding a proof-of-concept study to evaluate oral interferon in the treatment chronic cough in COPD and IPF patients. This experimental clinical study will be a Phase 2 randomized, double-blind, placebo-controlled, parallel trial in which 40 eligible volunteers with IPF- or COPD-associated chronic cough will be randomly assigned to one of two groups in equal numbers to receive either interferon alpha or placebo. Treatment will be given three times daily for 4 weeks, and patients will be followed for 4 weeks post-treatment to assess durability of response. The study will evaluate the ability of interferon alpha to reduce the frequency and severity of chronic cough in COPD patients. This study is ongoing and results are expected by the end of 2010.

For more information or to participate in this study, please visit:  http://www.clinicaltrials.gov/ct2/show/NCT00690885?term=oral+IFN&rank=1

or contact: Martin Cummins.

Hepatitis C

CytoPharm, Inc., AMAR’s licensee for Taiwan and China, launched a Phase 2, placebo-controlled, dose-ranging study of 165 hepatitis C virus-infected patients in Taiwan in the second quarter of 2009.  The study, which has been approved by both the US FDA and the Taiwanese Department of Health, is designed to test the ability of oral interferon to reduce the virologic relapse rate of patients who have completed standard therapy with pegylated interferon plus ribavirin.  Treatment time is 6 months with 6 months of post treatment observation.  Preliminary results are expected by the end of 2010.

For more information on this study, please visit: http://www.clinicaltrials.gov/ct2/show/NCT00695019?term=oral+IFN&rank=3

or contact: Martin Cummins.