Dendreon Corp. Announces Presentation of PROVENGE
May 31 13
Dendreon Corp. announced that four abstracts featuring PROVENGE (sipuleucel-T) data from ongoing Phase II sequencing studies and the PROCEED registry, and two abstracts highlighting preliminary Phase II data of DN24-02, an investigational active cellular immunotherapy in patients with surgically resected HER2+ urothelial cancer, will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) from May 31-June 4, 2013 in Chicago, IL. Data from an open-label study demonstrate the presence of existing immunological memory in advanced prostate cancer patients retreated with PROVENGE several years after initial treatment for androgen dependent prostate cancer (ADPC) in the Phase III PROTECT study. In addition, the retreatment appeared to boost product potency compared with prior treatment. Separately, data from two Phase II studies indicate that PROVENGE can be combined with androgen deprivation therapy (ADT) or abiraterone acetate plus prednisone. Studies evaluating PROVENGE and DN24-02 data at ASCO include: - A Randomized Phase II Study Evaluating the Optimal Sequencing of Sipuleucel-T and Androgen Deprivation Therapy (ADT) in Biochemically-Recurrent Prostate Cancer (BRPC): Immune Results (Abstract 5016). Data suggest that combining ADT with sipuleucel-T may augment adaptive immunity. PROVENGE is not indicated for the treatment of biochemically-recurrent prostate cancer. Poster discussion session: Genitourinary Cancer, June 1, 12:00 PM - 1:00 PM CDT., E Arie Crown Theater Lead Author: Emmanuel Stylianos Antonarakis, M.D., Sidney Kimmel Comprehensive Cancer Center at John Hopkins University, Baltimore, MD. - A Randomized Phase II Trial of Sipuleucel-T with Concurrent or Sequential Abiraterone Acetate (AA) Plus Prednisone (P) in Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (Abstract 5047). In a Phase II clinical study, the data suggest sipuleucel-T can be successfully manufactured during concurrent AA plus P with no significant changes in peripheral immune responses or alterations in adverse event profiles. General poster session: Genitourinary Cancer, June 3, 8:00 AM -- 11:45 AM CDT., S Hall A2 Lead Author: Eric J. Small, M.D., Department of Medicine, University of California San Francisco, San Francisco, CA. - Impact of Prior Docetaxel on Sipuleucel-T Product Parameters in PROCEED Patients (Abstract 5034). In an ongoing, Phase IV registry of patients administered sipuleucel-T regardless of prior docetaxel use, the data suggest that antigen presenting cell activation in sipuleucel-T is not impaired following docetaxel treatment. General poster session: Genitourinary Cancer, June 3, 8:00 AM -- 11:45 AM CDT., S Hall A2 Lead Author: Celestia S. Higano, M.D., FACP Seattle Cancer Care Alliance, Seattle, WA. - Open-Label, Multicenter Study of Sipuleucel-T in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Sipuleucel-T: Evaluation of Antigen Presenting Cell (APC) Activation and ELISPOT Data (Abstract 5053). In a study designed to evaluate the product potency in the retreatment of patients with sipuleucel-T, the data indicate the presence of existing immunological memory to sipuleucel-T years following initial treatment, and retreatment appeared to boost product potency compared with prior treatment. The patients were initially treated with sipuleucel-T when they had ADPC, and were retreated after they developed mCPRC. PROVENGE is not indicated for the treatment of ADPC and the safety and effectiveness of retreatment have not been established. General poster session: Genitourinary Cancer, June 3, 8:00 AM -- 11:45 AM CDT., S Hall A2 Lead Author: Tomasz M Beer, M.D., Oregon Health & Science University Knight Cancer Institute, Portland, OR. DN24-02: - Preliminary Safety, Product Parameters, and Immune Response Assessments From A Phase II Randomized, Open-Label Trial of DN24-02, an Autologous Cellular Immunotherapy (ACI), In Patients with Surgically Resected HER2+ Urothelial Cancer at High Risk for Recurrence (Abstract 4547). In an ongoing Phase II study, preliminary data on the adverse events and immune response of DN24-02 indicate that antigen presenting cell activity is comparable to that of sipuleucel-T and positive immune responses were observed. General poster session: Genitourinary (Nonprostate) Cancer, June 3, 8:00 AM -- 11:45 AM CDT., S Hall A2 Lead Author: Dean F. Bajorin, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY. - Preliminary HER2 Expression Data from NeuACT, the Phase II Randomized, Open-Label Trial of DN24-02 in Patients with Surgically Resected HER2+ Urothelial Cancer (UC) at High Risk for Recurrence (Abstract 4527). In an ongoing Phase II study, preliminary data on HER2 expression in urothelial cancer suggest a high incidence of HER2 expression (>74%) in urothelial cancer primary tumor and lymph node specimens from patients, with higher expression observed in lymph node specimens. Poster discussion session: Genitourinary (Nonprostate) Cancer, Tuesday, June 4, 11:30 AM -- 12:30 PM CDT., E354a Lead Author: Michael Press, M.D., University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.
Bernstein Litowitz Berger & Grossmann LLP Announces Proposed Settlement in the In re Dendreon Corporation Class Action Litigation
May 22 13
Bernstein Litowitz Berger & Grossmann LLP announced proposed settlement in the in re Dendreon Corporation class action litigation. A hearing will be held with respect to the settlement on August 2, 2013, at 10:00 a.m. before the Honorable James L. Robart in the United States District Court for the Western District of Washington, 700 Stewart Street, Courtroom Suite 14106, Seattle, WA 98101. The purpose of the hearing is to determine whether the proposed settlement of the securities class action claims asserted in this litigation, pursuant to which Defendants will pay or cause to be paid the sum of $40,000,000.00 in cash into a settlement fund in exchange for the dismissal of the litigation and a release of claims against Defendants and their related persons and entities, should be approved by the Court as fair, reasonable, adequate and in the best interests of the Class, which includes all persons and entities who purchased or otherwise acquired Dendreon common stock between April 29, 2010 and August 3, 2011, inclusive, excluding the Defendants, and their Related Persons.
Dendreon Corp. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2013
May 9 13
Dendreon Corp. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the period, the company reported total revenue of $67,594,000 against $82,074,000 for the same period in the last year. Loss from operations was $58,635,000 against $90,501,000 for the same period in the last year. Net loss was $72,005,000 or $0.48 per basic and diluted share against $103,914,000 or $0.70 per basic and diluted share for the same period in the last year. Non-GAAP net loss was $53,805,000 or $0.36 per basic and diluted share against $50,950,000 or $0.35 per basic and diluted share for the same period in the last year.