Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, and Topotarget A/S announced that the first patient has been dosed in an Investigator Initiated Trial of belinostat in combination with Tarceva for patients with Non-Small Cell Lung Cancer (NSCLC). The primary objective of the study is to evaluate the safety of belinostat in combination with Tarceva and to generate efficacy data in terms of progression-free survival, response rate and overall survival in patients with NSCLC.

“We are pleased that this trial investigating belinostat's safety and efficacy in combination with Tarceva has enrolled its first patient,” said Rajesh C. Shrotriya, MD, chairman, chief executive officer, and president of Spectrum Pharmaceuticals. “Belinostat is an HDAC inhibitor with the potential safety advantage that allows for full-dose combination with other chemotherapeutic regimens. Preclinical data has demonstrated synergy between belinostat and Tarceva. We look forward to the results of this phase I/II trial with Tarceva, which is an FDA-approved oral drug for advanced NSCLC.”

The study is an open-label, prospective phase I/II trial of belinostat in combination with Tarceva in patients with previously treated NSCLC. Belinostat is given orally on days 1-14, while Tarceva is administered orally continuously. The phase I/II trial is expected to enroll a total of 35 patients.

Belinostat (PXD 101) is a class I and II HDAC inhibitor that are being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various haematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.

Belinostat is currently in a registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), an indication for which it has been granted Orphan Drug and Fast Track designations by the US Food and Drug Administration.

Belinostat is also under investigation in a randomized phase II trial, as a combination therapy with carboplatin and paclitaxel, for Cancer of Unknown Primary (CUP). The CUP study is being run and fully funded by our partner Topotarget A/S. Additionally, the National Cancer Institute is currently conducting several clinical trials of belinostat in a variety of haematological and solid tumours, both as monotherapy as well as combination therapy.

Topotarget A/S is a Scandinavian based international biotech company headquartered in Denmark, dedicated to improving cancer therapies. In collaboration with Spectrum Pharmaceuticals, Inc. Topotarget currently focuses on the development in pivotal studies of its lead drug candidate, belinostat, which has demonstrated a clear anti-neoplastic effect in both haematological malignancies and solid tumours. Belinostat can be used in combination with full doses of chemotherapy, and is currently in a pivotal trial within PTCL (peripheral T-cell lymphoma) and phase II in cancer of unknown primary site (CUP). Topotarget's key cancer drug targets are HDAC, NAD+, mTOR, Fas ligand and topoisomerase II.

Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products.