Saturday, June 20, 2009

News from MacroGenics on Teplizumab

Two pieces of news from MacroGenics:
First, their phase-II human trial of teplizumab (called PROTEGE) is fully enrolled.
Second, they are starting a follow on phase-III study called PROTEGE ENCORE.

Teplizumab is a "humanized monoclonal antibody" which targets the CD3 part of the immune system in order to lower (or stop) the body's autoimmune response. This drug tries to prevent type-1, or lessen it's severity, by "turning down" the immune system's attack on the body's own pancreas cells. This basic approach has resulted in treatments (but not cures) for other autoimmune diseases. It does carry the risk that the body's immune system will not properly attack a real threat.

Fully enrolling a study (especially one this large: 530 people) is important because the major reason that studies are delayed, is trouble enrolling people in them. Especially a study like this where only "honeymoon" diabetics can participate, getting 530 often takes longer than planned. But once it is fully enrolled, that source of delay is removed.

The new study is a sign that MacroGenics is looking to productize this drug. The new study is focused on "clinical responses". That's research-speak to mean "does it help patients" or "do real people benefit in a useful way from this treatment". This is the kind of trial you do just prior to putting it on the market. The new study is 400 people and is scheduled from June 2009 to June 2012.

There is also a third PROTEGE trial which is ongoing, called PROTEGE Extension, which follows patients from the PROTEGE trial for an extended length of time.

If you view the path to a cure as a race, then with this announcement MacroGenics has pulled even with ToleRx which also has a CD3 targeted humanized monoclonal antibody in phase-III human trials. (That's the DEFEND trial of Otelixizumab.) It is interesting, to me at least, to see the dance of small companies and big companies. The PROTEGE trial is sponsored by MacroGenics. The PROTEGE Extended trial by MacroGenics / Eli Lilly, and the PROTEGE Encore trial by Eli Lilly, so you can see how Eli Lilly taking over the Teplizumab treatment from MacroGenics. Similarly, ToleRx has a partnership with GlaxoSmithKline for their Otelixizumab treatment.

(Note: MacroGenics/Eli Lilly calls PROTEGE a "phase-II/III trial", and the Encore trial a phase-III. But I considered PROTEGE a phase-II and Encore a phase-III.)

You can read more about it here:
http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials#MacroGenics
(although I really need to update this)

Read the press release here:
http://sev.prnewswire.com/health-care-hospitals/20090616/PH3265516062009-1.html

The web page home of this trial is here:
http://www.protegediabetes.org/

Here are the US Clinical Trial entries for all three studies:
http://www.clinicaltrials.gov/ct2/show/NCT00385697 (Protege)
http://www.clinicaltrials.gov/ct2/show/NCT00870818 (Extension)
http://www.clinicaltrials.gov/ct2/show/NCT00920582 (Encore)

Joshua Levy

3 comments:

Nick said...

this seems risky. Dr. Faustman's research into the BGC vaccine is more promising, as is Living cell technologies "diabecell' research in new zealand. Nobody cares about curing newly diagnosed diabetes...because the people who stand to benefit from this protege 'cure' have no idea they are going to be diagnosed with type 1 so they currently could care less about the study, and the people who have been suffering with the disease for years do not benefit at all. studies into new onset 'cures'are useless :-\

BetterCell said...

I totally am in agreement with your comment Nick.
Dr. Faustman was taken out of the Medical Research "Loop" because she doesn't allow her time to be wasted by all the '"Political B.S." found in medicine today.
.........and yes, it is time for new developments to take place for those of us with T1DM who have had this complex Disease for years. By new developments, I do not mean a new shiny blood glucose kit, but something more needed, wanted, and substantial like a molecular compound that will prevent/treat Complication that are a part of this Disease and have nothing to do with numbers other than bringing the onslaught quicker within a time variable.

Joshua Levy said...

I suggest that both Nick and BetterCell read my history history of Faustman's research, which is here:
http://cureresearch4type1diabetes.blogspot.com/2008/10/faustmans-research-part-1-history.html

Nick: I'm very interested in your comment that "Dr. Faustman's research into the BGC vaccine is more promising". Why do you believe that?

Her more recent round of research is showing no blood glucose improvements and no A1C improvements. Her previous round of research didn't use BGC at all. (It used CFA, a drug so toxic it can not be given to people at all, and even it's use on animals is discouraged!) And I've found five previous studies which tried to use BGC to cure or prevent type-1 diabetes, and none of them worked.

So my question is simple: why do you think she is on the right track now?

I'm not saying that Faustman is on the wrong track. Only that the is not "more promising" than many other researchers and I'm always interested in why people believe what they believe.

Joshua Levy