Corixa Announces Initiation of Phase I Clinical Trial of CRX-675 in Patients with Seasonal Allergic Rhinitis
Monday April 26, 7:00 am ET
TLR4 Agonist Product Candidate First to Enter Clinic From Corixa's Innate Immunity Program
SEATTLE--(BUSINESS WIRE)--April 26, 2004-- Corixa Corporation (Nasdaq:CRXA - News), a developer of immunotherapeutics, today announced the initiation of a Phase I clinical trial to test the safety and immune response activity of CRX-675 for seasonal allergic rhinitis (SAR). The trial is being conducted in the United States under a U.S. Food and Drug Administration (FDA) Investigational New Drug Application (IND). CRX-675 is a member of Corixa's family of proprietary compounds that interact with toll-like receptor 4 (TLR4).
As a TLR4 agonist, CRX-675 may influence innate immunity, the body's first line of defense against a variety of infectious pathogens. TLR4 agonists can also affect the immune system's response to allergens, antigens that trigger allergic reactions. Research and development activities focused on toll-like receptors have gained considerable attention in the past several years, as government and venture funding for TLR-related programs has increased, including a recent National Institutes of Health (NIH) grant to Corixa for $11.6 million.
The company's TLR4 agonists have been shown in preclinical studies to markedly reduce allergic reactions and to protect against infections, especially those that affect the respiratory tract. Moreover, preclinical testing of CRX-675 has shown that allergic animals become non-responsive to allergen challenge of the airways after one or two doses of CRX-675 administered in a nasal spray. CRX-675 is one of several TLR4 agonists in development by Corixa, all of which may be administered via non-injectable routes such as intranasal and potentially via oral administration.
"Our development of TLR4 agonists and antagonists represents a wealth of new and exciting product opportunities for Corixa," said Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "Initiation of this clinical trial represents an important step in our program development, and we are excited about the prospects of CRX-675 for the management of seasonal allergic rhinitis."
About the Trial
The Phase I study is designed to evaluate the safety of CRX-675 given as a single intranasal dose in adults allergic to ragweed pollen. Corixa expects to enroll 64 volunteers in the randomized, blinded, placebo-controlled, dose-escalation trial evaluating four different dose levels. The trial will be conducted at Creighton University in Omaha, Nebraska.
About Corixa's TLR Program
There are 10 kinds of TLRs, and each recognizes a different type of antigen. Corixa's proprietary compounds bind to TLR4, which can be found on a range of antigen-presenting cell types, including hematopoietic (blood-forming) cells, many epithelial cells, and cells associated with vascular stability. Corixa is exploring the use of these compounds as stand alone immunotherapies based on their ability to influence innate immune responses.
Corixa has discovered that some of its compounds act as agonists, or stimulants, of TLR4-mediated immune responses and some act as antagonists of TLR4 signaling. While all of the compounds are glycolipid in nature, their precise structure varies from compound to compound. Corixa has screened TLR4 agonist and antagonist compounds for their ability to protect animals from infection by a variety of pathogens and to promote anti-inflammatory immune reactivity... |
