Healthcare Industry News: FavId
News Release - June 11, 2007
Favrille Announces Data From Phase 2 Clinical Trial of FavId for Indolent B-Cell Non-Hodgkin's Lymphoma in EuropeData Reported at the Congress of the European Hematology Association
SAN DIEGO, June 11 (HSMN NewsFeed) -- Favrille, Inc. (Nasdaq: FVRL ), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced interim data from a Phase 2 clinical trial of FavId« in patients with indolent B-cell non-Hodgkin's lymphoma (NHL). The data were reported at the Congress of the European Hematology Association in Vienna on Saturday.
"We are encouraged by the preliminary results from this trial, which included patients with differing forms of indolent B-cell NHL," said Emanuele Zucca, M.D., co-investigator and Head of the Lymphoma Unit at the Oncology Institute of Southern Switzerland. "We are also encouraged by the feasibility of administering a patient-specific active immunotherapy, manufactured in the U.S., in patients in Europe."
A copy of Dr. Zucca's presentation is now available on Favrille's website at http://www.favrille.com.
This ongoing Phase 2 clinical trial is open to patients with various indolent forms of B-cell NHL who are either treatment-na´ve, relapsed or refractory following prior chemotherapy, or relapsed following a prior response to Rituxan. The trial is expected to enroll 15 patients, but enrollment may be expanded if activity is seen in any specific patient subset.
FavId is a patient-specific, Id/KLH active immunotherapy for the treatment of B-cell NHL. Favrille completed enrollment in its pivotal Phase 3 clinical trial of FavId following Rituxan induction therapy in patients with follicular B-cell NHL in January 2006. The trigger for the analysis of the primary endpoint in the trial, time to tumor progression (TTP), is based on a specific number of patients reaching disease progression. This is currently projected to occur around the end of 2007. The Company has a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) for its Phase 3 trial, and has also received Fast Track designation for FavId from the FDA.
About Favrille, Inc.
Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, FavId, is based upon unique genetic information extracted from a patient's tumor. FavId is currently under investigation in a pivotal Phase 3 clinical trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost- effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of cutaneous T-cell lymphoma.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Favrille's product candidates, proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to progress and timing of clinical trials for FavId, including difficulties or delays in development, testing, manufacturing and marketing FavId or Favrille's other product candidates; Favrille's ability to obtain marketing approval for FavId or Favrille's other product candidates and the timing of any such approvals; Favrille's ability to manufacture sufficient quantities of FavId for use in clinical trials and, if FavId receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using FavId; potential delays in patient enrollment; Favrille's ability to obtain additional financing to support its operations; and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. In addition, conclusions regarding the safety and efficacy of Favrille's product candidates cannot be made until the results of future clinical trials of longer duration in more patients are known. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward- looking statements contained in this release as a result of new information, future events or otherwise.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.