potential role of aerobic exercise in modulating cardiotoxic effects of molecularly

[Lani]

targeted agents--both antiangiogenic and growth factor inhibitors are covered

It is a relatively early review of what may be being discovered

http://theoncologist.alphamedpress.o.../18/2/221.full

[kittyqueen]

Really interesting thank you Lani xxxx I am a great advocate of exercise and have just had my 13th herceptin and so far no ill effects.

KQ

['lizbeth]

Thank you Lani, I appreciate the information on hypertension's affect on the LV, as well as the rest. I lucked out into a prescriptive exercise program for cancer survivors which truly restored my quality of life after treatment. My doctor wanted my mets (exhalation measurement) above 10 to help prevent recurrence.

Sorry if I popped your bubble on low expressers. All research for cancer is important. I didn't realize at the time, but I guess we Her2+++ are no longer going to be the darlings of breast cancer research with the rush to capture the new, bigger market. I've gone from duh to oh shit!

[Lani]

No bubble popped here. Since Dr Paik's paper showing some her2 "negative" patients incorrectly classified as her2+ in the her2 adjuvant trials did well on herceptin, there have been many theories as to why that occured and even clinical trials to test hypotheses (as you alluded to) Max Wicha's
finding seems the most intriguing to date and the most likely to someday lead to a major change in practice in my opinion.

['lizbeth]

Lani,

Well you are certainly loyal to Max Wicha.

It doesn't seem to me that the members of this board are going to benefit from this research, since we are higher expressors of Her2. So happy the "triple negatives" are being reclassified. I've watched several friends pass away that might have benefited from Herceptin. Tragic really that lower expressors were not included 10 to 15 years ago.

[Lani]

I wouldn't call myself loyal to Max Wicha--to be loyal i would think one would have to have some kind of relationship with him, which I don't...just admire his research, his open inquisitive mind and his persistence when going "against the grain" when his peers scoff and dismiss his research. I felt the same way about Judah Folkmann( whom I was fortunate to have asked a few questions of), who was the father of "angiogenesis" research, ridiculed for years, but whose research culminated in treatments such as Avastin, sutent and others. Judah Folkmann was also a kind, kind soul and caring physician par excellence--you could just tell from his lectures (many are on YouTube)

Of course the article is of interest to those previously considered unlikely to benefit from herceptin, the her2- or low group.

I think you are dismissing the importance of this research to those who are her2+ as well. Why should those her2+ stem cells in the bone marrow be the source of recurrence of her2+ breast cancer as well?

If we don't look (ie do biopsies and aspirations) we will never find out

I think the point of the article is that we should not exclusively look at the characteristics(ER, her2 etc) of the tumor in the breast to decide how to treat as it may be the characteristics of the stem cells in the marrow which drive recurrence/metastasis, and that, of course, is what kills people.

['lizbeth]

Lani,

You are certainly passionate about the marrow. I'm just looking at the whole situation from another angle.

Herceptin is already in clinical trials for lower expressors. So the participants in the Herceptin/E75 trial will already receive this benefit.

It appears to me that George People's has already taken the concept one step further and added a second way to prevent recurrence. I admire his & his colleagues' work. I truly see dedicated doctors and scientist working to find a way for the immune system to handle the prevention of mets.

My concern is that instead of working together to advance the treatment for us, the Her2+++ patients, there will be a mad dash to be the first one to the market for lower expressors. I already saw that on one company's website. I also saw the long list of companies behind Max Wicha's name who he financial benefits from.

Yes, I already figure out myself that my cancer was using my immune system to evade destruction. And since many of these cells are produced in the marrow, it only makes sense that cancer affected cells are there. So the concept is not new to me.

But I also know that WBCs can pretty much go anywhere in the body. Which is an incredible survival tool. Even if we can find evidence of the cancer in the marrow, I suspect the cells can go into the nervous system to evade destruction. Hence, the spinal mets and brain mets.

While I applaud the work. I feel instinctively that there is a better answer than the bone marrow.

I also am skeptical about cancer as just a genetic malfunction. It seems to have too much intelligence, a great ability to thrive and adapt.

Lani, my intuition is telling me that there is a better answer to stopping cancer. The bone marrow sounds promising, but I feel cancer can outwit that treatment.

Honestly, even with the current amazing treatments that have come out. And the current ideas of slowing or stopping cancer in clinical trials - these are just a small step toward conquering this disease.

The lower expressor market is larger, so I see the emphasis on her2 treatment heading there. I can only hope that future clinical trials will have an arm for folks like me, the higher expressor of her2.

I also know that a friend who is receiving a PARP inhibitor said that she was lucky to get in the trial as the market for that treatment was too small for it to be economically viable.

Our current cancer research system isn't set up for these small markets. As treatment becomes more personalized - does this mean those with markers that are more rare are just shit out of luck? As a cancer survivor that concerns me. I've benefited from the enormous amounts of funding that chased after the Her2+++. Now I see myself moving into the minority, and it is an "oh shit" moment.

[Lani]

01/30/2013

Orphan Drugs Good Business
I like to publish market research, data and facts to this site -- because they often interest me and it make it easy for me to find the information again in the future with the indexes.

I pulled this data from a GEN article by Gail Dutton that cites a Thomas Reuters study as the original source. The thrust of the article is that making orphan drugs makes good economic sense now. As a reminder, an orphan drug (in US) is one directed to a disease that affects fewer than 200,000 people, in Europe it is to a disease with an incidence lower than 5 in 10,000. The EMA recognizes 8,000 rare diseases and the FDA 6,000.

Since the Orphan Drug Act was passed in 1983, the FDA has approved 350 new drugs to about 200 diseases. Orphans grew at a CAGR of 26% between 2000-2010 versus a 20% CAGR for non-orphans. Orphans account for approximately 22% ($50 B) of total drug sales. It's further interesting, orphan drugs (developed and filed) have a 93% chance of success versus 88% success rate for non-orphans. It pays to be in a niche by yourself. The PV for the two drug types are virtually the same as well $637 M per year and $638 M per year respectively.

Companies (e.g. Shire, Genzyme, Biomarin) with Orphan Drug Business models are successful now and that would seem to be the case for the immediate future too. Here's the list for the Top Selling Orphan drugs:

Rituximab Oncology
Ranibizumab Opthamology
Somatrophin EPR, metabolism
Lenalidomide Oncology
Imatinib mesylate Oncology
Filgrastim Hematology
Glatiramer acetate MSP
Rec Factor VIII Hematology
Bosentan monohydrate Cardiovascular
Bortezomib Oncology Source: Thomas Reuters
Posted by Bruce Lehr Jan 30th 2013.

Posted at 04:05 PM in Market Data & Facts & Research, Orphan, Neglected & Rare Diseases | Permalink | Comments (0) | TrackBack (0)

['lizbeth]

Well thanks Lani, that makes me feel a little better.