Glufosfamide is an analog of a widely used chemotherapeutic agent (ifosfamide), but with greater specificity and a better safety profile, targeting metabolically active tumors and hypoxic tumor regions. It has been evaluated in more than 450 patients in multiple clinical studies. Data from a previous phase III trial indicated a 25% improvement in median survival in a very difficult to treat indication, 2nd line pancreatic cancer, although the study size and trial design was insufficient to prove statistical significance.
A key finding of the prior phase III study was the shortened survival associated with glufosfamide treatment of insulin-taking patients (40 of 286 test subjects). Glufosfamide is a glucose-conjugated prodrug, its activity affected by a patient’s diabetic status and use of insulin. Based on this and other valuable information from the prior study, and with assistance from key clinical oncologist advisors, Eleison has designed a new clinical study and regulatory plan for glufosfamide with a high probability of achieving statistical significance and regulatory approval. Eleison began enrolling patients in this pivotal phase III 2nd line study in 2014, with 30 sites currently open for enrollment in the U.S. For more information about this clinical study, please visit the US FDA Website.
Each year, more than 46,000 Americans are diagnosed with pancreatic cancer, the fourth leading cause of cancer deaths in the United States. At present, surgery, radiation, and chemotherapy (gemcitabine, erlotinib) provide for the most part only palliative benefit as five year survival rates are only 6%. Eleison owns exclusive worldwide rights to glufosfamide, but has sub-licensed marketing rights to leading pharmaceutical companies in China and South Korea for the Chinese and South Korean markets.
Inhaled Lipid-complexed Cisplatin (ILC)
Eleison has an exclusive worldwide license to ILC, a novel, sustained release formulation of cisplatin in a nanoscale lipid based complex administered via inhalation, in development for pediatric osteosarcoma (OS) - bone cancer. ILC was designed to deliver high levels of sustained release cisplatin targeted to the lung, without systemic-related toxicities. ILC has been evaluated in 89 patients in four clinical studies, with evidence of efficacy in several cancer types including lung and bronchoalveolar.
In pediatric OS, approximately 35% of patients fail first-line therapy, mostly with metastatic recurrence only in the lungs, and with poor prognosis (five year survival of such patients is <25%). In a prior phase II study of ILC, 10 of 19 children with pulmonary recurrence of OS achieved a clinical benefit. Remarkably, among a group of 3 patients treated with ILC after a complete surgical removal of their pulmonary tumors and 1 patient with micronodular disease, 3 patients remained disease free after one year (normally there is recurrence in less than six months). By the treatment and prevention of such pulmonary recurrences, ILC is potentially the first lifesaving breakthrough in the treatment of OS in more than a generation.
Eleison is currently enrolling patients in a phase II clinical study by leading osteosarcoma clinical investigators throughout the U.S., to evaluate the safety and efficacy of ILC in patients with osteosarcoma lung metastases. For more information about this clinical study, please visit the US FDA Website.
Eleison has sub-licensed the marketing rights of ILC for the Chinese market to an emerging Hong Kong based pharmaceutical company. In conjunction with this agreement, Eleison and the Chinese partner plan to commence this year a large phase II study of ILC in patients with non-small cell lung cancer, the leading cause of cancer deaths worldwide.