One other thing to remember - when it comes to cancer drugs, in at least some cases - and I admit I don’t know these two drugs - a drug whose safety profile would be completely unacceptable for more healthy people will be approved for cancer patients - even if 50% of the people taking the drug die, that might be better than the survival rate without the drug!
So besides the “in mice” issue, you’d have to take a long, close look at the safety issues with the drugs.
For imatinib: (from Wikipedia) - In the United States, the Food and Drug Administration has approved imatinib as first-line treatment for CML.[1] Imatinib has passed through Phase III trials for CML, and has been shown to be more effective than the previous standard treatment of α-interferon and cytarabine. Although the long-term side effects of imatinib have not yet been ascertained, research suggests that it is generally very well tolerated (eg. liver toxicity was much less than predicted). Broadly, side effects such as edema, nausea, rash and musculoskeletal pain are common but mild.
Severe congestive cardiac failure is an uncommon but recognised side effect of imatinib and mice treated with large doses of imatinib show toxic damage to their myocardium
(It also costs $32k/year . . . . ain’t no way insurance companies will spring for that)
Sunitinib: An oral agent, sunitinib has been generally well tolerated. Adverse events were considered manageable and the incidence of serious adverse events low. [3] [6]
The most common adverse events associated with sunitinib therapy are fatigue, diarrhea, nausea, anorexia, hypertension, and skin discoloration. In the placebo-controlled Phase III GIST study, adverse events which occurred more often with sunitinib than placebo included diarrhea, anorexia, skin discoloration, mucositis/stomatitis, asthenia, altered taste, and constipation. [2] [6]
Serious (grade 3 or 4) adverse events occur in ≤10% of patients and include hypertension, fatigue, asthenia, diarrhea, and hand-foot syndrome. Lab abnormalities associated with sunitinib therapy include lipase, amylase, neutrophils, lymphocytes, and platelets. Hypothyroidism has also been associated with sunitinib. [2]
Most adverse events can be managed through supportive care, dose interruption, or dose reduction.
Of course, the $64k question is STILL going to be beta cell regeneration. Even if a 7 week course knocks out the autoimmune response, the question for those of us whose beta cells are on permanent vacation is how to get that function back.
The studies I’d like to see are all the honeymoon drugs (Tolerx, Macrogenics, Diamyd, etc.) + some form of beta cell regeneration factor like INGAP. Of course, everything involved would need to get through all phases of testing, so good luck on that coming through any time soon!