Regeneron Submits IND for the IL-4/13 Dual Trap in Patients With Asthma
BusinessWire, Tuesday, July 30, 2002 at 08:11
TARRYTOWN, N.Y.--(BW HealthWire)--July 30, 2002--
Third Product Candidate Based on Proprietary Trap Technology
to Enter Clinical Trials
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a clinical development program for the Interleukin-4 and Interleukin-13 Dual Cytokine Trap (IL-4/13 Trap) in patients with asthma.
The proposed Phase I study is designed to evaluate the safety and tolerability of increasing doses of the IL-4/13 Trap in adult patients with mild to moderate asthma. The IL-4/13 Trap is based on Regeneron's proprietary Trap technology.
Asthma is an inflammatory disorder of the airways that is one of the most common chronic diseases worldwide. Approximately 17 million people in the U.S. suffer from asthma, and it is one of the most prevalent chronic diseases in children under the age of 18. It results in almost 500,000 hospital admissions and approximately 5,000 deaths each year. The direct healthcare costs attributable to asthma are estimated at nearly $10 billion annually.
Asthma is caused by an abnormal immune response to common substances in the environment. Symptoms typically include recurrent episodes of wheezing, breathlessness, chest tightness, and coughing. Independent research implicates the overproduction of two functionally related cytokines, Interleukin-4 (IL-4) and Interleukin-13 (IL-13), as being an important contributor to the abnormal immune response that can lead to asthma.
The IL-4/13 Trap was designed using Regeneron's proprietary Trap technology. In laboratory experiments, the IL-4/13 Trap binds both IL-4 and IL-13 with high affinity. The clinical program will seek to test the hypothesis that blocking the actions of both of these cytokines simultaneously will provide a therapeutic benefit in patients with asthma.
"The prevalence of asthma has increased sharply over the last 20 years, and research has demonstrated that IL-4 and IL-13 may have in an important roll in precipitating asthmatic responses," observed Merdad Parsey, M.D., Ph.D., Director of Immunology at Regeneron. "We are eager to gain clinical exposure with the IL-4/13 Trap in asthmatic patients, the third product candidate from our proprietary Trap program to enter clinical development."
Regeneron's Custom-Designed Trap Program
Cytokines are soluble proteins that act as messengers in immune-mediated inflammatory processes. If present in excess, inflammatory cytokines can be harmful and have been linked to a variety of diseases, including asthma and rheumatoid arthritis. Blocking inflammatory cytokines is a proven therapeutic approach, which is the basis for a number of medicines that have already been approved for inflammatory conditions such as rheumatoid arthritis.
In a number of publications, Regeneron scientists reported a breakthrough in understanding how receptors work for an entire class of interleukins in the human body (e.g., Davis et al., Science 260:1805 (1993); Stahl et al., Science 263:92 (1994)). Based on these findings, Regeneron developed a series of cytokine and growth factor blockers, referred to as "Traps." These include Traps for IL-1, IL-4, and IL-6, a single dual Trap which blocks both IL-4 and IL-13, as well as a Trap for vascular endothelial growth factor (VEGF Trap). Because these Traps mimic the body's natural receptors, they have been shown in laboratory and disease model experiments to be extremely effective at catching and holding the cytokines and growth factors. In certain disease states, when these cytokines and growth factors are present at elevated levels, their capture and blockade via administration of Traps may help ameliorate disease activity.
In preclinical studies, these Traps are more potent than other antagonists, potentially allowing lower dosage levels. Moreover, these Traps are comprised entirely of human-derived protein sequences, which may positively affect their safety and tolerability profile. Because pathological levels of IL-1, IL-4, IL-6, IL-13 and VEGF seem to contribute to a variety of disease states, these Traps have the potential to be evaluated for use in a range of therapeutic indications. In July 2002, Regeneron initiated a Phase II clinical trial of the IL-1 Trap in patients with rheumatoid arthritis. In December 2001, the Company initiated a Phase I clinical trial of the VEGF Trap as a potential treatment for harmful angiogenesis or vascular leak in settings of cancer and/or other conditions.
About Regeneron
Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates in clinical trials for the potential treatment of obesity, rheumatoid arthritis, and cancer, and has preclinical programs in asthma, allergies, and other diseases and disorders. Regeneron's platform technologies include Targeted Genomics(TM), Functionomics(TM), and Designer Protein Therapeutics(TM). |
