Enzon Pharmaceuticals, Inc has initiated phase I clinical trial of Oncaspar to assess its safety and potential utility in the treatment of advanced solid tumours and lymphomas in combination with Gemzar (gemcitabine HCl for Injection).
The company also announced the US Food and Drug Administration (FDA) completed review of the Company's Investigational New Drug (IND) application for the use of recombinant human Mannose-Binding Lectin (rhMBL), for the prevention and treatment of severe infections in patients with multiple myeloma with low levels of MBL undergoing high-dose chemotherapy and hematopoietic stem cell transplantation. Clinical trials are expected to begin enrolment later this year.
"The advancement of these two important oncology programmes is a testament to our commitment to both reinvest in our brands and build our pipeline," stated Jeffrey H. Buchalter, Enzon's chairman and CEO. "Oncaspar moving into clinical trials in solid tumours, also marks an important turning point for the company as we begin to explore broader markets of unmet medical need."
Oncaspar phase I trial, the multi-centre trial is being lead by Dr Amita Patnaik M.D. at the Cancer Therapy and Research Centre (CTRC) and is being conducted with Dr Mitesh Borad MD at the Translational Genomics Research Institute (TGEN) and Dr Jean Grem MD at the University of Nebraska Medical Centre. The open-label, dose-escalation trial is designed to assess the safety and maximum-tolerated dose of Oncaspar in combination with Gemzar in patients with advanced solid tumours and lymphomas.
rhMBL is a protein therapeutic, being developed for the prevention and treatment of severe infections in individuals with low levels of Mannose-Binding Lectin (MBL). Over 10 per cent of the general population is estimated to be MBL-deficient. MBL deficiency may explain why some but not all individuals who are immune suppressed develop infectious complications even when they receive prophylactic anti-infectious treatment. Studies have shown a correlation between low MBL levels and susceptibility to serious infections in patients immune suppressed from chemotherapy, including patients with multiple myeloma undergoing high-dose chemotherapy and hematopoietic stem cell transplantation.
Enzon acquired the worldwide rights, excluding the Nordic countries, to rhMBL from NatImmune A/S in September 2005. In December 2004, NatImmune completed a Phase 1 clinical trial that evaluated the safety and pharmacokinetic profile of single- and multi-dose intravenous administration of rhMBL in 28 MBL-deficient, healthy volunteers. Results from the phase 1 trials demonstrated that rhMBL therapy is well-tolerated.