Light Sciences Oncology Inc. closed a $30 million Series B financing to support ongoing pivotal trials with Litx, a light-activated drug/device combination product for cancer.
The Snoqualmie, Wash.-based company originally had intended its second financing to take place on the public markets, but plans for an estimated $86.25 million initial public offering fizzled. Instead, Light Sciences Oncology stayed the private course, following its $67 million Series A in late 2005 with the current round. (See BioWorld Today, April 26, 2006.)
Series B investors were not disclosed, and company executives were not available for comment. Series A investors included Essex Woodlands Health Ventures, Scandinavian Life Science Venture, Novo A/S, New Science Ventures, Adams Street Partners, Johnson and Johnson Development Corp., China Development Industrial Bank and Larkspur Capital Corp.
The new money will be used to continue two Phase III clinical trials with Litx, short for Light Infusion Therapy, both of which were designed under special protocol assessments with the FDA.
The first is a Phase III trial in hepatocellular carcinoma (HCC), initiated in August 2006 and slated to wrap up in early 2009. The 200-patient, open-label, active-controlled, randomized study will compare survival in patients receiving Litx to those receiving whatever standard of care their physician chooses, given the limited options for treating the disease. Yet HCC patients soon may have a new treatment alternative. Last month, Onyx Pharmaceuticals Inc. and Bayer HealthCare Pharmaceuticals Inc. submitted a supplemental new drug application seeking approval of kidney cancer drug Nexavar (sorafenib) in liver cancer.
A second Phase III trial in colorectal cancer metastatic to the liver was initiated this month. The 450-patient, open-label, active-controlled, randomized study will compare the Litx system plus standard chemotherapy to chemotherapy alone in improving progression-free survival and overall survival. In a previous 27-patient Phase II trial in colorectal cancer metastatic to the liver, the combination of Litx and chemotherapy resulted in a tumor response rate of 24 percent and a time to progression of 61 days, compared to 10 percent and 33 days for standard chemotherapy.
Beyond liver cancer, Light Sciences Oncology is conducting a 12-patient, open-label Phase II trial to evaluate increasing light doses of Litx in primary or recurrent glioma. The company also plans to start a Phase I trial of Litx in benign prostate hyperplasia (BPH).
The move into BPH follows Light Sciences Oncology's December 2006 purchase of all Litx intellectual property from Light Sciences Corp., the parent company that originally spun out Light Sciences Oncology in late 2005 to focus on cancer applications of Litx. With all patents now securely in hand, Light Sciences Oncology can expand beyond cancer into benign neoplasms such as BPH and uterine fibroids, vascular disease, dermatology and other applications.
Litx treatment involves the insertion of a flexible light emitting diode (LED) array into the tumor using a procedure similar to a biopsy. The patient then is injected with LS11 (talaporfin sodium), a light-activated cancer drug approved in Japan for early stage bronchopulmonary cancer. LS11 remains inactive until the LED array is activated, which causes the conversion of molecular oxygen to singlet oxygen and kills the tissue around the LED array, resulting in an anti-angiogenic effect.
Light Sciences Oncology licensed rights to LS11 from Meiji Seika Kaisha, which markets the drug as Laserphyrin in Japan.
The results of efforts to develop light-activated treatments have been mixed. QLT Inc. gained a landmark approval for the light-activated drug Visudyne (verteporfin) in wet age-related macular degeneration, but it has since suffered at the hands of non-light-activated competitors like Lucentis (ranibizumab, Genentech Inc.) and Macugen (pegaptanib sodium, OSI Pharmaceutical Inc.). Miravant Medical Technologies Inc.'s light-activated wet-AMD drug Phototrex (SnET2) also faced setbacks, including an approvable letter.
Progress in other indications has been similarly checkered. Last year, QLT's light-activated BPH drug LT0074 failed to meet its primary efficacy objective in a Phase II study. Yet Photofrin (porfimer sodium), which QLT licensed to Axcan Pharma Inc., is marketed for esophageal cancer, endobronchial non-small-cell lung cancer and Barrett's esophagus. DUSA Pharmaceuticals Inc. also continues work on its photodynamic therapy, Levulan (aminolevulinic acid HCl), which is approved in some countries for treating pre-cancerous actinic keratoses and is being studied for acne, photodamage and esophageal dysplasia.