Biotech Values

[onco_investor]

Randomized Phase II trials are considered the gold standard for clinical development however you also introduce a few issues that you have to decide what is in the best interest of the overall program.

Namely

1. If you already know that enrollment rates are low for all clinical trials then introducing randomized Phase II trials will only make this worse as many patients may decide not to enroll because they will not be assured of gettting Reolysin. The open label regular Phase IIs that ONCY has run gave them the best hope to enroll at rates that were acceptable. Even so the rates of enrollment have been very challenging as has been documented in many clinical trials not just ONCY.

2. Some people also beleive that giving terminal cancer patients a placebo is not ethical so you wait until you have to run a randomized Phase III before you introduce randomization... and then into the standard of care not placebo.

Another issue to consider is that Reolysin clinical testing is moving to test RAS+ and EGFR+ NSCLC and Colorectal patients instead of all NSCLC patients so you are getting right to the target population that has the specific deficiency that is the target of Reolysin's MOA. It has been announced that ONCY will be running a 3 Arm Pancreatic Phase II cancer trial mentioned in messagel #158 on the iHub ONCY board.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47671946&txt2find=arm

From the RBC Capital Markets presentation in March 2010<We're about to initiate a Phase II in colorectal cancer, in combination with Carbo/Tax again (our favorite drug combination), and a pancreatic cancer study … a randomized study where we're comparing Carbo/Tax/Reolysin against Gemzar, and the third arm is Carbo/Tax alone. It's an interesting time for us, and like my colleagues on the panel here, it's nice to be in Phase III's, or starting Phase III's finally.>

Nice to finally see the Phase II Reo + Low Dosage Radiation results finally released which showed near 100% effectiveness in stabilizing these terminal cancer patients. There a several Phase IIs reporting data this year so it should be an exciting 6-9 months.

The key trial that should drive a partnership will be the Phase II NSCLC interim data release sometime this year.

onco_investor