A STUDY FOR RAGWEED POLLEN ALLERGY

Study Summary: This clinical research study will assess the efficacy of an investigational sublingual (under the tongue) tablet to replace immunotherapy injections in inducing immune tolerance and relieving symptoms associated with rhinoconjunctivitis (hay fever) caused by ragweed in study subjects 18 to 50 years of age.

Investigational Study Drug: The investigational study drug is an oral allergen formulation of a rageweed extract.

STUDY INFORMATION:

• Study subjects will undergo a screening process. Subjects who continue to qualify will receive investigational study medication or placebo (an inactive substance) in a double-blinded manner (neither the study subject nor the staff at the research site will know which medication has been assigned).

• The investigational study medication or placebo (an inactive substance) will be taken before, during and after the ragweed season for a total of 52 weeks.

• Rescue medication and an EpiPen® will be provided as back up medication.

• Study procedures include physical exams, labwork, pulmonary function tests and allergy testing.

• There is no charge for participation.

• A stipend will be provided to study participants for study related time and /or travel in the amount of $25 per visit. There are 11 visits in the study; however, there may be several extra visits as needed. NOTE: There is no stipend for a pre-study visit, if such a visit is scheduled.

• Principal Investigator: Jeffrey Rumbyrt, M.D. of Denver Allergy & Asthma Associates

• Male or female, 18 to 50 years of age

• Must have a history of ragweed allergy during the past 2 years

• Must have received treatment for rhinoconjunctivitis (hay fever) during the past ragweeed pollen season (fall, 2008)

• Females who have the potential to become pregnant must be willing to use an acceptable method of birth control during the study

• For other inclusion/exclusion criteria information, please talk with a study coordinator

FOR FURTHER INFORMATION, PLEASE CONTACT:

Study Coordinators: Mary Reid, Jodi Frazier, Cheri Casey or Dara Stillman

Western States Clinical Research, Inc., 9201 W. 44th Avenue, Wheat Ridge, CO 80033

Phone: 303-940-0909 (This is a message line; we will return your call within 24 hours.), FAX: 303-940-0308

E-mail: research@wscrinc.com

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Our mission is to promote the health and well-being of humanity by the development of new medicines through high-quality clinical research and a closely held philosophy of striving for excellence.

To find out about the studies that are currently underway at our office, please see Clinical Trials.

Western States Clinical Research Inc. specializes in research studies related to gastroenterology, asthma and allergy, pulmonology, internal medicine, ophthalmology and dermatology. Our website contains information for physicians, pharmaceutical companies and individuals interested in participating in clinical research.

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