In 2010, Light Sciences Oncology (LSO) expects to obtain final data from two Phase III trials of Aptocine. LSO has completed treatment of patients in a Phase III trial of Aptocine in hepatocellular carcinoma (HCC) and has nearly completed patient enrollment in a Phase III trial for metastatic colorectal cancer (MCRC). LSO completed a Phase II trial of Aptocine in glioma in 2008.
Recently, LSO launched a Phase II clinical trial in benign prostatic hyperplasia (BPH), or enlargement of the prostate, and has clinical or preclinical programs in cardiovascular, ophthalmic and dermatologic diseases. Aptocine is also in Phase I development for pediatric neurofibromatosis, type 1 (NF-1).
In August 2005, LSO reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase III trial in HCC. The trial enrolled 208 patients at sites in Singapore, Hong Kong, South Korea, the Philippines, Malaysia, Thailand, India, Croatia, Serbia, Poland and Sweden. The purpose of the study is to assess the survival of patients treated with Aptocine versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC). LSO anticipates final data from the trial in 2010, followed shortly thereafter by regulatory filings worldwide.
LSO reached another agreement with the FDA on an SPA in January 2007, for the Phase III clinical trial in MCRC. It is a 450-patient trial, conducted primarily at sites in Europe and India, to assess the progression-free survival and overall survival of patients treated with Aptocine plus chemotherapy versus chemotherapy alone. Completion of patient treatment and final data release is also expected in 2010, followed by regulatory filings.
Aptocine is a water-soluble drug targeted by a single-use, disposable drug activator included with the drug. According to LSO, Aptocine has three mechanisms of action: direct tumor cytotoxicity, apoptosis caused by vascular shutdown and potential anti-tumor immune stimulation. In clinical studies to date, there has been no evidence that Aptocine causes the serious toxicities associated with traditional cancer treatments.
Besides HCC, MCRC and glioma, LSO is focusing on several cancers for the initial development of Aptocine: prostate cancer, pancreatic cancer, lung cancer, nasopharyngeal cancer, head and neck cancer, and kidney cancer. Aptocine targets a potential market of $12 billion globally for the treatment of cancer, both as monotherapy and in combination with traditional therapies such as surgery, radiation, chemotherapy, so-called ‘targeted’ vascular disrupting therapies and other drugs designed to activate the immune system against cancer.