Invivodata Captures Primary Efficacy Data In Largest Controlled Allergy Vaccine Trial

Main Category: Allergy
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 19 Jun 2008 - 6:00 PDT

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invivodata inc., the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced that its DiaryPRO® field-based ePRO system was used to capture primary efficacy endpoint data in the recently unblinded Phase III study of Pollinex® Quattro, a vaccine being developed by Allergy Therapeutics® plc (AIM:AGY) to treat the symptoms of seasonal allergic rhinoconjunctivitis (SAR).

"Allergy Therapeutics has set a new standard in developing allergy vaccines," said Dr. Wolfgang Summa, vice president, Europe and Asia Pacific, at invivodata ltd. "We are very proud to have supported the largest controlled allergy vaccine study ever conducted in this patient population, once again demonstrating the value of our ePRO technology in large, international clinical trials."

invivodata designed a DiaryPRO solution for over 1,000 international trial subjects to use and over 90 investigative sites to administer. During the trial, investigative sites across the United States, Canada and Europe trained patients to use DiaryPRO in their native language. Patients then recorded the daily frequency and severity of allergy symptoms during the entire 2007 grass pollen season. Data collected with DiaryPRO supported the study's primary efficacy endpoint, demonstrating that Pollinex Quattro has statistically significant clinical benefits over placebo. Allergy Therapeutics intends to use the results of this Phase III trial to support a marketing authorization application in the European Union.

"We are very pleased with the results of this landmark trial and the manner in which invivodata captured this critical data," said Dr. Jutta Amersdorffer, head of Clinical Operations & Pharmacovigilance at Allergy Therapeutics. "Their understanding of the complexities of international clinical trials and their flexibility in meeting our changing trial needs, including the addition of significantly more sites and patients during the recruitment phase, was critical to its success."

About invivodata inc.

invivodata combines behavioral science, information technology, and clinical research expertise to capture high-quality clinical trial data directly from patients. invivodata's electronic Patient Reported Outcomes (ePRO) solutions, which are based on over 20 years of research, deliver reliable patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague paper-based self-report data. invivodata's solutions include comprehensive trial-support services that facilitate the collection of ePRO data, and web-based access to study data and operational reports that give researchers and sponsors visibility into study progress and improve trial efficiencies. invivodata's solution has been used in more than 200 trials and is the industry-leading ePRO system in delivering primary efficacy data for FDA drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, Pa., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, Calif., USA. For more information visit http://www.invivodata.com.

About Allergy Therapeutics

Allergy Therapeutics plc is a London Stock Exchange (AIM) listed specialist pharmaceutical company focused on allergy vaccination. It has a growing, profitable core business achieving sales of allergy vaccines of £26 million in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. The Company is expanding its infrastructure and recently commenced operations in the United Kingdom, Poland, the Czech Republic, Slovakia and Austria.

Allergy Therapeutics has certain exclusive intellectual property rights to the use of MPL in both injected and sublingual vaccines. In addition to progressing to Phase III studies with Pollinex Quattro, the Company has completed a Phase I/II oral vaccine study incorporating MPL.

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