EpiCept Announces New Crolibulin Data Presented at ASCO 2013 Support Further Evaluation in Anaplastic Thyroid Cancer
Jun 3, 2013
TARRYTOWN, N.Y.--(BUSINESS WIRE)--
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that new data supporting further evaluation of crolibulin were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO 2013), taking place May 31 to June 4, 2013 at the McCormick Place Convention Center in Chicago. Crolibulin is EpiCept's small molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas.
Crolibulin is a microtubule destabilizing agent that disrupts vascular endothelial cells, and in turn, blood flow to tumors.
Presentation details are as follows:
Abstract #6074 — Head and Neck Cancer Session, Saturday, June 1, 2013, 8:00am-11:45am
Title: "Phase I/II trial of crolibulin and cisplatin in solid tumors with a focus on anaplastic thyroid cancer: Phase I results"
Authors: "Ann Wild Gramza, Sanjeeve Balasubramaniam, Antonio Tito Fojo, Jean Ward, Samuel A. Wells; National Cancer Institute, National Institutes of Health, Bethesda, MD
Preclinical studies showed synergism of crolibulin (CRO) associated with cisplatin (CIS). The authors of the poster reported the Phase I portion of the study designed to assess the safety and tolerance of CRO and CIS in patients with solid tumors. Twenty-one patients were enrolled and received CIS and CRO up to 100/20mg/m2 of CIS/CRO.
Diagnoses were as follows: anaplastic thyroid cancer (16), urethelial carcinoma (2), prostate carcinoma (2) and mesothelioma (1). The most common grade 3 toxicities were lymphopenia (33%), hypertension during infusion (29%), hyponatremia (24%), anemia (19%) and ypophosphatemia (10%).
The authors concluded that the combination of CIS plus CRO shows interesting results and deserves further evaluation as a regimen for anaplastic thyroid cancer. The Maximum Tolerated Dose of CIS/CRO is 100mg/m2 IV day 1 and 20mg/m2 IV days 1, 2, 3 every 21 days. This combination is well tolerated, with toxicity primarily related to CIS. The Phase II portion of this trial will compare CIS/CRO versus CIS alone in anaplastic thyroid cancer.
Stephane Allard, M.D., Chief Medical Officer of EpiCept, commented, "The results of this study further expand the body of clinical data showing the clinical promise for crolibulin in solid tumors. We are encouraged by these results. EpiCept very shortly will initiate the Phase II portion of this trial in collaboration with the National Cancer Institute."
Crolibulin has demonstrated potent anti-tumor activity in both preclinical and early clinical studies. In preclinical in vitro and in vivo studies, crolibulin has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. In April 2008 EpiCept announced positive clinical data from a Phase I study of crolibulin in patients with solid tumors. In the future, crolibulin could be integrated into Immune Pharmaceuticals' NanomAbs® technology, antibody nanoparticle conjugate technology developed by Prof. Shimon Benita of the Hebrew University of Jerusalem.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of pain and cancer. The Company's pain portfolio includes AmiKet™, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies. The Company's product Ceplene®, when used concomitantly with low-dose IL-2 is intended as remission maintenance therapy in the treatment of AML for adult patients who are in their first complete remission. The Company sold all of its rights to Ceplene® in Europe and certain Pacific Rim countries and a portion of its remaining Ceplene® inventory to Meda AB in June 2012. The Company has other oncology drug candidates in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. In November 2012 EpiCept and Immune Pharmaceuticals Ltd., a privately held Israeli company, entered into a definitive merger agreement. The transaction, as amended, is anticipated to close during the third quarter of 2013 and is subject to satisfaction of certain customary closing conditions, including approval by a majority of EpiCept shareholders. The combined company will be focused on developing antibody herapeutics and other targeted drugs for the treatment of inflammatory diseases and cancer.
About Immune Pharmaceuticals Ltd.
Immune Pharmaceuticals Ltd. is an Israel and U.S.-based biopharmaceutical company focused on the development of next-generation antibody therapeutics to address unmet medical needs in the treatment of inflammatory diseases and cancer. Immune licensed worldwide rights for systemic indications of bertilimumab from iCo Therapeutics (TSX: ICO) in June 2011, while iCo retained rights to all ophthalmic indications. iCo originally licensed exclusive worldwide rights to bertilimumab in 2006 from MedImmune Limited (formerly known as Cambridge Antibody Technology Limited), the global biologics unit of AstraZeneca. Additionally, Immune has licensed from Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem, injectable applications of the antibody nanoparticle conjugate technology (NanomAbs®) developed by Prof. Shimon Benita. For more information, visit the Immune website at www.immunepharmaceuticals.com.
In connection with the proposed merger transaction, EpiCept has filed a preliminary proxy statement with the U.S. Securities and Exchange Commission (SEC) and will file a definitive proxy statement with the SEC seeking appropriate stockholder approval. STOCKHOLDERS OF EPICEPT AND OTHER INVESTORS ARE URGED TO READ THE PRELIMINARY PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS TO THE PRELIMINARY PROXY STATEMENT), WHICH IS AVAILABLE NOW, AND THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS TO THE DEFINITIVE PROXY STATEMENT) WHEN IT BECOMES AVAILABLE, REGARDING THE PROPOSED TRANSACTION BECAUSE IT CONTAINS AND WILL CONTAIN IMPORTANT INFORMATION. EpiCept's stockholders can obtain a copy of the preliminary proxy statement, and will be able to obtain a copy of the definitive proxy statement when it becomes available, as well as other filings containing information about Immune and EpiCept, without charge, at the SEC's Internet site (www.sec.gov).
Copies of the preliminary proxy statement, and the definitive proxy statement when it becomes available, and any filings with the SEC that are incorporated by reference in the proxy statement can also be obtained, without charge, by directing a request to EpiCept Corporation, 777 Old Saw Mill River Rd, Tarrytown, NY 10591, Attention: Investor Relations, Telephone: (914) 606-3500.
Participants in the Solicitation
EpiCept and its directors and executive officers and Immune and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of EpiCept in connection with the proposed transaction. Computer Share AB will assist EpiCept in soliciting proxies from Swedish stockholders. Information regarding the direct and indirect interests of these directors and executive officers and Computer Share AB in EpiCept, Immune and the merger transaction is included in the preliminary proxy statement, and will be included in the definitive proxy statement when it becomes available, of EpiCept referred to above. Additional information regarding the directors and executive officers of EpiCept is also included in EpiCept's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, which was filed with the SEC on March 5, 2013. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at EpiCept at the address described above.
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Source: EpiCept Corporation
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