of OXY111A in healthy volunteers. This will be a typical study in which 60 to 70 volunteers get a variety of escalating doses to gauge safety of the drug. Importantly, NormOxys will also take blood measurements of a biomarker called P50, which will measure whether the drug is doing what it’s supposed to do at the molecular level. That scientific readout will be correlated, NormOxys hopes, with clinical evidence that suggests the drug can help patients exercise more vigorously.
If all of that goes according to plan, NormOxys will quickly move on to the next step. That will be a study of people who are actually sick with heart failure—not healthy volunteers, Tolar says. That trial should be ready to start as soon as late summer or early fall. It’s possible that NormOxys could have its first evidence that the drug works in patients by the end of 2010, he says.
Using the NormOxys approach for cancer is a little more complicated, and it will take a little longer to bear fruit, if it ever does. The idea starts with the assumption that about three-fourths of tumors are in a stressed, low-oxygen state. As I described back in the December feature, such a “hypoxic” state of tumors prompts them to come up with novel ways to stay alive in that stressed state, by producing new blood vessels to nourish themselves, and by switching off normal cell suicide pathways that control the regular turnover of healthy cells.
It might sound crazy to think you can kill tumors by supplying them with MORE oxygen, but that’s what NormOxys is saying. By delivering more oxygen to the tumor, it then switches out of the stressed-out survival mode, and stops growing new blood vessels and keeps its regular cell-suicide switches operating like normal. That should allow natural “apoptosis” processes to essentially kill the tumor, NormOxys says.
Tolar didn’t tell me when the company can get its cancer trial up and running, but he says he expects to have results by this time next year, May 2011.
Once those results arrive, Tolar says he hopes to be negotiating with a pretty strong set of cards in his hand. He has been sowing the seeds of expectations in pharmaland for a while now, and says he’s particularly jazzed to have Care Capital join this financing because of its connections in Big Pharma. Care Capital partner Argeris “Jerry” Karabelas, a former CEO of pharmaceuticals for Novartis, is joining the NormOxys board, which is currently chaired by former GlaxoSmithKline CEO J.P. Garnier.
“We do not have your usual venture finance guys, but we have people who have run large pharma businesses,” Tolar says. “They have a clear understanding of what needs to be done.”
