Monoclonal Antibody Research

[indigo girl]

http://www.earthtimes.org/articles/show/crucell-receives-nih-award-for-the-development-of-influenza-monoclonal-antibodies,929133.shtml#

A different approach to treatment and prophylaxsis for influenza has been needed. This company was given an NIH award for the development of monclonal antibodies for treatment of influenza infections.

With the world now at pandemic alert level six, and recent reports of A/H1N1 oseltamivir resistance occurring, the timing of this contract is extremely important" said Dr. Jaap Goudsmit, Crucell's Chief Scientific Officer. "It will allow Crucell and its partners to pursue a new approach for the treatment of the disease caused by both seasonal and pandemic influenza strains."

Crucell has developed a set of unique human monoclonal antibodies that have been shown to protect against a wide range of distinct seasonal and pandemic influenza viruses. These antibodies are active against the seasonal H1N1 viruses, which show widespread resistance to oseltamivir (Tamiflu), the current first-line therapeutic. They were also found to be active against the pandemic 'swine flu' H1N1 influenza viruses and the avian H5N1 'bird flu' viruses, which are still circulating in Asia. In December 2008, Crucell published pre-clinical data showing the prophylactic and therapeutic efficacy of these antibodies in the online journal PLoS ONE. This was followed in February 2009 by a breakthrough publication in the journal Science elucidating the mechanism of action of the most potent of these antibodies.

Crucell has discovered the first human monoclonal antibodies for the prevention and treatment of the 'bird flu' strain H5N1, as well as H1N1, which is similar to the strain responsible for the 'Spanish flu' in 1918. The antibodies provide immediate protection and neutralize a broad range of H5N1 and H1N1 strains in pre-clinical models. In December 2008, Crucell presented data showing that the mAb CR6261 was 100% successful in preventing infection with H5N1. When given after H5N1 infection, Crucell's mAb demonstrated the ability to prevent death and cure disease in all cases. The mAb also performed significantly better than the anti-influenza drug oseltamivir for the prevention and treatment of H1N1 infection, illustrating the potential use for seasonal applications as well. This is especially important as the resistance of influenza strains for oseltamivir is rapidly increasing.

[caroladybelle, BSN, RN]

Having worked with monoclonal antibodies, I don't know how well this will work with general public very well.

They tend to have much more problematic side effects than standard therapies, be EXTREMELY expensive, and many tend to be more problematic to adminster.

Take Avastin that often requires copays of $1,000 to several thousand per month. As well as side effects that give one pause.

Take Rituxan, requiring careful monitoring during infusion, with frequent hypersensitive reactions, also expensive. Take Herceptin, which I have had reasonably healthy (except for the cancer diagnosis) women, code during infusion, also expensive.

The targetted therapies such as EGFR/TKIs, some of which cause severe rashes that look like acne - a rash that is ironically worse in people that are getting effective cancer control/treatment, and mild in people that it is not controlling the cancer as well.

We have mylotarg that routinely causes fevers (up to 105), rigors, crashes in blood pressure and need to to start pressors.

We have people in this country that do not get vaccinated because it is inconvenient, because they got a sore arm, or felt headachy for a day or two. We have people that will not take antibiotics, because it gives them diarrhea, or it is expensive. We have people that will not take meds because they make them break out or gain weight.

It will be challenging to develop a monoclonal antibody that is financially successful, affordable and tolerable enough for the average public to "accept" it and all that goes with it.

[indigo girl]

I thought it sounded too good to be true. But, it really would be of tremendous advantage to have something else to use for flu victims besides the neuraminadase inhibitors. We have put all of our eggs in one basket with Tamiflu and Relenza, so to speak. We are possibly going to lose Tamiflu some time in the not too distant future due to drug resistance.

It is very helpful to have feed back from someone who has worked with a therapy that most of us have never even heard of.