Previous Phase IIa and Phase IIb Clinical Data in Pancreatic Cancer Both Phase IIa and Phase IIb clinical studies on Oncosil have already been completed. A brief summary of both trial results is provided below.
Phase IIa The Phase IIa study in patients with late stage, inoperable pancreatic cancer was completed in January 2008.
This was a fixed dose study in 17 patients, with the primary objective of evaluating the safety of the product and secondary objective of assessing initial efficacy based on overall survival and progression free survival. The trial was conducted in London (UK) and Singapore.
The results from the trial, based on 24 weeks follow-up, demonstrated: Product safety No clinically significant product-related adverse events.
No significant systemic leakage of ( 32P), from the site of implantation.
Product efficacy
CT scan analysis of patients demonstrated significant tumouricidal activity with a disease control rate of 82%.
Reduction in pain associated with pancreatic cancer.
Median progression free survival was 121 days.
Median overall survival was 309 days.
The trial concluded that patients with pancreatic cancer receiving Oncosil (who are also receiving standard concomitant chemotherapy with gemcitabine) is easily deliverable, tolerable and potentially effective.
Phase IIb A dose ranging study was conducted to determine the optimal dose of Oncosil.
Six patients were enrolled in London (UK) and Birmingham (UK) and received either 200Gy or 400Gy as a single injection. The study was completed in August 2009.
Product safety
No clinically significant product-related adverse events.
No significant systemic leakage of ( 32P), from the site of implantation.
Product efficacy
CT scan analysis of patients demonstrated significant tumouricidal activity with a disease control rate of 100%.
Optimized Dose
The highest dose studied, 400Gy (4 times the dose used in the Phase IIa trial) was determined to be the optimal dose.
Enigma Clinical Program and Regulatory Strategy Moving Forward
Under the Licence Engima plans to enter discussions with regulatory authorities in UK with the view to obtaining a potential CE Mark for Oncosil as soon as practicable.
The company also intends to conduct a potential Phase III study and discussions with regulatory authorities and manufacturers will take place as soon as reasonably practicable. It is anticipated this trial may have approval to commence during 2013.
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