SAN DIEGO, Jan. 31 /PRNewswire/ --

Idun Pharmaceuticals, Inc. today announced the results of its Phase 1 clinical trial of IDN-6556. The drug was safe and well tolerated in a clinical study involving 50 normal adults. Evaluation of patients with mild hepatic impairment is ongoing. In the Phase 1 study, IDN-6556 was administered in both single doses and for a week of therapy with various doses. The drug was well tolerated in all groups of subjects.
 
"We are excited to have completed this Phase 1 stage of the drug's development," said Dr. David Shapiro, Chief Medical Officer and Executive Vice President at Idun. "This drug may prove to be useful in multiple liver diseases and we will shortly start Phase 2 studies to evaluate its effects on different groups of hepatic patients. We will conduct Phase 2 trials of individuals with hepatitis C virus (HCV) infections, alcoholic liver disease and, subsequently, additional trials of individuals experiencing acute alcoholic hepatitis. HCV affects about 4 million Americans and another 200 million people worldwide. Acute alcoholic hepatitis is an often-lethal condition that affects about 85,000 people in the U.S. alone and for which there is no effective treatment. We believe that IDN-6556 can play an important role in the standard care for people with HCV, acute alcoholic hepatitis, and many other liver diseases."
 
"There are literally more than a half-billion people in the world suffering with liver diseases that may benefit from this drug," added Dr. Steve Mento, Idun's President and CEO. "The success of the Phase 1 trial of our caspase inhibitor is the first clinical step to a new and important therapy for patients with liver disease. It also validates Idun's approach to small molecule drug development and the role that apoptosis modulators can play in the treatment of a number of diseases. We've always believed that caspase inhibitors would be effective drugs for a number of diseases. IDN-6556 is the first broad-spectrum caspase inhibitor to be studied in humans.
 
"This is just the beginning of many exciting new opportunities that can come from Idun's technology. We have programs in earlier stages of development in cardiovascular disease, inflammation, central nervous system diseases, and cancer with just as much potential."
 
Idun Pharmaceuticals, Inc. is a biopharmaceutical company located in San Diego, CA, creating innovative human therapeutics with a primary focus on controlling apoptosis, or programmed cell death. Apoptosis is a genetically controlled normal physiological process mediated by a cascade of intra-cellular proteins. Too much, inappropriate, or too little apoptosis is believed to play a role in many important human diseases. Idun believes that controlling the cell death process will have utility in treating cancer, neurodegenerative diseases, ischemic disorders and cardiovascular disease. The company has adopted a commercialization strategy encompassing strategic collaborations with major pharmaceutical companies; internal, independent development of selected small molecule therapeutics; and out-licensing of diagnostics, gene therapies, and bioproduction technologies. Idun has an extensive patent portfolio covering the fundamental and core technologies involved in the regulation of cell death and has established partnerships with Abbott Laboratories in cancer, with Elan Corporation, plc in stroke, and Becton Dickinson and Company in research reagents.
 
Some of the statements in this press release are forward-looking statements and do not guarantee future performance and involve risks and uncertainties. Actual results may differ substantially from the results that the forward-looking statements suggest for various reasons. These forward- looking statements are made only as of the date of this press release.
 

A DGReview of :"A randomized trial of high-dose interferon alpha-2b, with or without ribavirin, in chronic hepatitis C patients who have not responded to standard dose interferon"
Alimentary Pharmacology & Therapeutics

03/18/2002
By David Loshak
 

Patients with hepatitis C who do not respond to standard doses of conventional interferon might benefit from higher doses plus ribavirin.

This combination was well tolerated among patients in a pilot study reported by specialists at the University of Texas Southwestern Medical Center, Dallas, Texas, United States. They pointed out that conventional interferon monotherapy fails to achieve virological clearance in most patients infected by hepatitis C.

However, the specialists conjectured, high-dose induction regimens might improve the initial clearance of virus. Also ribavirin might improve sustained response rates once clearance was achieved.

The specialists recruited 25 chronic hepatitis C patients who had not responded to standard dose interferon monotherapy. The study compared the efficacy and safety of re-treatment with an induction regimen of high-dose interferon alpha-2b either alone or with ribavirin.

Previous virological non-responders to standard dose interferon (3-5 MU three times weekly for 12 weeks) were randomised to receive one of two open-label regimens for 36 weeks.

Ten patients (Group A) received interferon alpha-2b 10 MU daily for 10 days followed by 5 MU daily for 74 days and then 5 MU three times weekly for 24 weeks. A further 15 patients (Group B) received the same regimen plus ribavirin 1000-1200 mg/day at day 11. All 25 patients were followed up for 24 weeks.

At the end of treatment, virological response was noted in one group A patient and in eight Group B patients. The sole responder in group A and three in group B relapsed on follow-up.

The apparent difference between the groups, with a 33 percent sustained response rate in Group B compared with none in Group A, nearly reached statistical significance.

Alimentary Pharmacology & Therapeutics 2002; 16(3):381-388. "A randomized trial of high-dose interferon alpha-2b, with or without ribavirin, in chronic hepatitis C patients who have not responded to standard dose interferon"

Sweden Approves Expanded Use of Naturally-Derived Alpha Interferon

PLANTATION, FL -- January 17, 2002 -- Viragen, Inc. and Viragen International, Inc. today announced the approval of its application to Swedish regulatory authorities to expand the use of Viragen's natural alpha interferon.

This broadened approval extends use of the drug to include the treatment of patients afflicted with any and all diseases in which patients were or became resistant to treatments using recombinant (synthetic) interferon. The most common maladies treated with interferons include hepatitis C, multiple sclerosis and certain cancers.

Viragen's natural alpha interferon had previously been approved in Sweden and certain other countries for the treatment of patients with hairy cell leukemia (HCL) and chronic myelogenous leukemia (CML) who did not respond to recombinant interferon regimens. Global interferon sales are estimated to exceed $2 billion per year.

Viragen's newly appointed chief medical officer, Professor Orjan Strannegard, MD, stated, "Recombinant interferon products are the dominant treatment for a broad range of chronic viral and malignant diseases. However, a significant percentage of patients cannot tolerate the adverse side-effects typically associated with recombinant regimens or fail the therapy, probably due to the formation of neutralizing antibodies. For those patients that do fail, there are few safe and effective alternatives. Our expanded Swedish approval provides further evidence that it may be advantageous for a patient to be treated with Viragen's naturally-derived interferon. This drug has been demonstrated to have excellent effects in various viral diseases and cancers. It is well tolerated by the treated patients and it is able to elicit a renewed response in patients that have been resistant to recombinant interferons."

Natural interferon, produced by white blood cells, is part of the human immune system. It is one of the body's natural defensive responses to foreign substances such as viruses, and is so named because it "interferes" with viral growth. Recombinant interferons, which currently dominate the interferon market, are genetically engineered and are sometimes recognized as "foreign" by the body's immune system. Recombinant interferons usually contain only one subtype of interferon as compared to multiple subtypes produced by human white blood cells.

SOURCE Viragen, Inc

HepaSense, a joint venture of Isis Pharmaceuticals and Elan Corp., has announced start of a Phase II clinical trial of its antisense inhibitor ISIS 14803 for patients with chronic hepatitis C.

The open-label study will enroll 40 patients at six sites across the United States. During the trial, patients will receive increasing doses of the intravenous drug over a 12-week period to test for reduction of the virus.

In a small Phase I/II trial, ISIS14803 was shown to reduce the hepatitis C virus in patients who had the most common and drug-resistant form of the virus.

All but one of those patients previously had failed interferon-based therapy.

"We observed encouraging results in the initial Phase I/II trial that provided us with a foundation for further study of this drug," said Dr. F. Andrew Dorr, Isis Vice President and Chief Medical Officer. "Results from this study, in which patients will receive doses of ISIS 14803 for three months, will help us determine the next steps in developing this drug."

Other Sources: Isis Pharmaceuticals