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Biotec Pharmacon ASA (OSL:BIOTEC) Oslo 13 January, 2009: Biotec Pharmacon is experiencing a faster than expected patient enrolment in the second of its two phase III studies with SBG for treatment of diabetic ulcers. However, the oral mucositis program is developing somewhat slower than planned. Patient enrolment for the new phase III diabetic ulcers study commenced in November, and 40 percent of the total planned patient population has already been included in the study. In the other phase III study - the "Nottingham-study" - more than 100 of targeted 120 patients have now been enrolled, and Biotec Pharmacon confirms its target to file for marketing authorisation with SBG for treatment of diabetic ulcers in mid-2010. "We are glad to see that most of the clinical centers we have chosen have shown a strong commitment to our diabetic ulcers studies. The fast patient enrolment lends confidence to our milestone schedule with SBG for this common and serious medical condition," says CEO Lars Viksmoen in Biotec Pharmacon. An estimated 3.5 million diabetes patients in the OECD-area annually develop foot and leg ulcers. No standard treatment is currently available, and these diabetic ulcers may develop into chronic conditions with a high risk of infections and potentially amputation. Biotec Pharmacon's immune stimulating drug SBG (soluble beta-glucan) reactivates immune cells in the patients' skin and thus enhances the body's own wound healing capabilities. In the fourth quarter 2008 patient enrolment also commenced in the first of two phase III studies with SBG for the prevention and treatment of oral mucositis. This is a painful and potentially serious side-effect of radiotherapy for treatment of head and neck cancer. The progress has been relatively slow, although in excess of 10 percent of the planned population of 120 patients has been included. An interim analysis is planned after two thirds of the patients have been treated. The upstart of a second phase III oral mucositis study was planned for the end of the fourth quarter, but has been delayed for administrative/logistic reasons. "We received signals from EMEA that one study might be sufficient to apply for a marketing authorisation, provided that the results would be compelling, but decided for strategic reasons to run two studies in parallel. However, with a delayed start-up of the second study and at the back ground of the current financial environment, Biotec Pharmacon has now decided to put the second study on hold until results from the first study becomes available to mitigate and reduce overall risk", says Viksmoen. Depending on the results of the ongoing study, this may have an impact on timing for filing for marketing authorisation. "From a financial point of view, putting the second oral mucositis study on hold reduces risk and preserves cash, as this reduces our 2009 spending level by some NOK 20-25 million", says Viksmoen. Biotec Pharmacon had a net cash position of NOK 124 million at the end of 2008. The company considers this sufficient funding through the first half 2010, provided there are no further modifications to the current ongoing phase III programs. As previously stated, the company also aims to enter into one or more commercial partnerships during 2009, on either a global or regional level. Biotec Pharmacon also has three ongoing phase I/II studies with SBG for use in combination with monoclonal antibodies in immunotherapies of cancers. The patient enrolment has been completed in the studies with SBG for neuroblastoma in children at Memorial Sloan-Kettering Cancer Center and with SBG for non-Hodgkin lymphoma at Rikshospitalet, whereas three quarters of the patients have been included in a study with SBG for breast cancer at Ullevaal.
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