June 1, 2013

Adam Feuerstein: [ASCO '13:] Amgen's Cancer-Killing Virus Shows Skin-Cancer Survival Trend

Read Adam Feuerstein's article on Amgen and T-Vec here. Good for Amgen & T-Vec is good for Provectus & PV-10.

"Amgen is the first company to demonstrate that a so-called "oncolytic virus" -- known as talimogene laherparepvec (T-Vec) -- can eliminate skin cancer in a late-stage clinical trial. T-Vec also works, in part, by harnessing the immune system of patients, which suggests to Amgen that the two different immune therapy approaches to killing cancer cells could be combined." I believe Moffitt has combined PV-10 and PD-1 agents.

"T-Vec's tumor shrinkage rates in the 20-30 percent range for melanoma are slightly lower than responses seen by the so-called PD-1 inhibitors being developed by Bristol-Myers and Merck." PV-10 tumor shrinkage rates in the 30-50% range (Phase 2 data) for melanoma are dramatically higher than T-Vec and PD-1 inhibitors despite being constrained or limited in treatment through the Phase 2 trial protocol. A Phase 3 trial under the SPA (that should be agreed to with the FDA), should such a trial ultimately be run, would have treatment without any limits of any concern (i.e., as many retreatments of as many visible tumors as necessary).

"Additional survival data will be presented this afternoon which shows the survival difference between T-Vec and GM-CSF patients growing over time, Chang says. This is consistent with the idea that cancer immunotherapy takes longer to be effective." 

"Doctors inject T-Vec directly into tumors unlike most cancer drugs that are administered orally (as a pill) or intravenously into a vein. In Jan. 2011, Perlmutter explained that BioVex wouldn't have been worth Amgen's investment if OncoVex proved capable of only eliminating tumors via direct injection. The tumor burden in advanced cancer patients, especially those with skin cancer, is too great to treat them effectively."

"T-Vec, however, appears to activate a patient's immune system enough to target and eliminate tumors that are not directed injected. This so-called off-target or systemic response is what grabbed Amgen's attention and ultimately led to the company's decision to acquire BioVex."

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