ACTION! Help Save the Life of Darcy Doherty, Father of Three Children to get immunotherapy drug for melanoma..Jim Breitfeller

ACTION! Help Save the Life of Darcy Doherty, Father of Three Children to get immunotherapy drug Anti-PD-1 (BMS-936558)  for melanoma.




Please write to Dr. Elliot Sigal at Bristol Myer Squibb
Elliott.Sigal@bms.com

Dr. Sigal is the Director of Research at BMS.
Please send a note to Dr. Sigal requesting that BMS open compassionate use for Mr. Doherty. I know it is a long shot/ Hail Mary Pass but, base on my research, this drug with the combination of IL-2 may be able to beat the odds.

Bristol Myer Squibb says "At Bristol-Myers Squibb, we are firmly focused on our Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases."

Is this all lip service? Let see if BMS puts their money where their mouth is and grant this compassionate care use for this derserving family. Doherty with his clinal trial of Yervoy (Anti-CTLA-4 therapy) helped get the drug FDA approved through his survival data. The least Bristol could do is to grant the dying man compassionate use of the next generation drug called Anti-PD-1, (BMS-936558)

Bristol-Myer Squibb needs to show some compassion.

It is their ETHICAL Responsibility.


“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”
~Charles Darwin~
 Take Care,
Jimmy B

 

Dying man fights to get experimental drug from Bristol-Myers Squibb..Melanoma ..Jim Breitfeller

Emily Jackson Staff Reporter Darcy Doherty’s last chance at life lies in an experimental drug. The yet-to-be-approved treatment is the only option left for the 48-year-old father of three with metastatic melanoma, believes his oncologist Dr. David Hogg, an attending physician at Princess Margaret Hospital. But maker Bristol-Myers Squibb (BMS) refuses to give Doherty the drug, saying it’s not yet safe for use outside the clinical trial, which Doherty was excluded from because of new cancer growth in his brain. That reason is simply not good enough for Doherty’s family and friends. If he will certainly die without the drug, why not let him try it? “They have an ethical responsibility to try to save a life,” his wife Rebecca Cumming said as she handed out “Help Save Darcy” stickers at the Ride to Conquer Cancer Sunday. “I think they’re afraid it will be harder to get the drug to market if the drug brings harm to patients like Darcy.” About 30 family friends were at the fundraiser to promote a change.org petition pressuring BMS to give Doherty access to the drug by Father’s Day. Wait much longer, Cumming said, and it will be too late. More than 171,000 have signed the plea. “We love our dad very much and we want a lot more time with him,” Doherty’s emotional 13-year-old son Ganden said in a video. A cancerous mole was first removed from Doherty’s back in 2003. By 2007 the cancer spread to his brain. He survived because of a then-experimental drug. His doctor said immune system off-switch blocker BMS-936558, which has had success in phase one of testing, could have similar benefits. BMS is aware of the petition, but did not budge on its decision. The company empathizes with patients who have limited treatment options, said spokeswoman Sonia Choi in a statement Sunday. Compassionate use requests are carefully reviewed using information from a patient’s physician, she said. To get access, the benefits must outweigh the risks. “At this time, there are not enough data on BMS-936558 to allow its use outside of a clinical trial.” Choi could not provide a timeframe on when more data might become available. The trial’s final stages are set for later this year or early 2013. “In the long term, the best way to ensure the broadest access for patients is to successfully register a medicine with health authorities through the conduct of well-controlled clinical trials.” “There’s no obligation on the drug companies to provide compassionate relief,” said Bernard Dickens, professor emeritus of health law and policy at the University of Toronto. BMS “can’t invest money in handing out unproven products if they’re not going to get data for study purposes.” But if the drug wasn’t safe enough to test on humans, it would not go to stage-two testing, argued advocate Frank Burroughs, founder of American organization the Abigail Alliance for Better Access to Developmental Drugs. For now, Doherty tires quickly. Sitting in his wheelchair at the fundraiser, the former big-bank financial services managing director called the petition an “amazing show of the human spirit.” He thinks it’s “kind of crazy” that he can’t get the drug. “It doesn’t hurt to give a guy a chance.” Source:http://www.thestar.com/news/article/1209218--dying-man-fights-to-get-experimental-drug-bristol-myers-squibb-won-t-give-him We have seen this type of action numerous times with BMS.They did this with Yervoy in the early days, closing compationate use. They appear to have no compassion or ethics, Just Greed!!!! to make a buck. I believe Bristol Myer Squibb is doing a disservice to the Cancer Community especially the Melanoma Patients.





"What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life."

There is no commitment to patients with stage IV Melanoma.

They have dollars Signs in the eyes and don't give a cr%& about the patients.

This is what Big Pharma has become. (Greed)

Take Care,

“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”

~Charles Darwin~

 Take Care,

Jimmy B
 

Bristol Meyer Squibb, Where do you draw the Line in the Sand?Melanoma ..Jim Breitfeller

Bristol Meyer Squibb, Where do you draw the Line in the Sand?



“What I found over the next two and a half years of "researching the research" is a scandal in medical science that is at least the equivalent of any of the recent corporate scandals that have shaken Americans' confidence in the integrity of the corporate and financial worlds. Rigging medical studies, misrepresenting research results published in even the most influential medical journals, and withholding the findings of whole studies that don't come out in a sponsor's favor have all become the accepted norm in commercially sponsored medical research. To keep the lid sealed on this corruption of medical science—and to ensure its translation into medical practice—there is a complex web of corporate influence that includes disempowered regulatory agencies, commercially sponsored medical education, brilliant advertising, expensive public relations campaigns, and manipulation of free media coverage. And last, but not least, are the financial ties between many of the most trusted medical experts and the medical industry. These relationships bear a remarkable resemblance to the conflicts of interest the Securities and Exchange Commission recently brought to a halt after learning that securities analysts were receiving bonuses for writing reports that drove up stock prices with the intent of bringing in more investment banking business.”

Quoted from:

Overdosed America by John Abramson MD, page 9


Well come to find out that BMS/Medarex is opening up new clinical trials with Ipilimumab and continue to keep the compassionate use trial closed. How ethical is that?

Where do you draw the Line in the Sand?

When big pharma is involved in clinical development, it usually means large-scale clinical trials with patients and multiple sites.



Here are the trials:

Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia

Start Date: August 2009

Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00732186

Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Start Date: February 2009

Estimated Study Completion Date: Feb 2013
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00836407


Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma

Start Date: February 2009

Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 33
ClinicalTrials.gov Identifier: NCT00790010

Laboratory-Treated T Cells With or Without Ipilimumab in Treating Patients With Metastatic Melanoma

Start Date: February 2009

Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00871481

Study of Immunotherapy to Treat Advanced Prostate Cancer

Start Date: May 2009

Estimated Study Completion Date: December 2012

Estimated Enrollment: 800
ClinicalTrials.gov Identifier: NCT00861614
Further study details as provided by Bristol-Myers Squibb:



Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer


Estimated Enrollment:30
Study Start Date:February 2009
Estimated Primary Completion Date:
February 2013 (Final data collection date for primary outcome measure)ClinicalTrials.gov Identifier:NCT00836407

A Phase I Study of Repetitive Dosing of Anti-CTLA-4 Antibody (MDX-010) in Combination With GM-CSF in Patients With Metastatic, Androgen-Independent Prostate Cancer


Estimated Enrollment:36
Study Start Date:November 2009
Estimated Primary Completion Date:
November 2013 (Final data collection date for primary outcome measure)



These are all trials that were started after the halting of the compassionate Use. Bristol-Meyer Squibb thinks we the Melanoma Patients are expendable so they continued there quest to seek out new uses for the Drug as the STRING OF PEARLS.

.And the FDA has turned a blind Eye and gave it its unoffical approval to allow this to happen.
Where are the comsumers being protected. Without the patients, Bristol Meyer would have no trials. Very STRANGE BEDFELLOWS TO SAY THE LEAST.



Take Care,

Jimmy B

Why Can't Bristol Meyer Squibb share with the Patients?Melanoma..Jim Breitfeller

Why Can't Bristol Meyer Squibb share with the Patients?

We the patients take all the risk and become their consumer base. Or should we just say No!!!!
It is not like they are short on Cash.

James M. Cornelius, I challenge you to do what is ethically right and reinstate the compassionate drug (Ipilimumab)use for the critically ill patients of our nation. Stop raping them blind.

"What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life."

~Bristol Meyer Squibb~

It is all Lip service. A con Job!!!!! They don't care about the patients that don't qualify for their trials. They have no compassion whatso ever.

Bristol CEO ‘Out Hunting’ for Deal With $10 Billion



By Shannon Pettypiece

Jan. 28 (Bloomberg) -- Bristol-Myers Squibb Co. Chief Executive Officer James M. Cornelius said his company is “out hunting” for deals and has $10 billion in cash.

Bristol-Myers’s acquisition and licensing efforts will be the same in 2010 as they were last year when the New York-based company acquired Medarex Inc. and split off its Mead Johnson Nutritional Co., Cornelius said today in a conference call with reporters. He added that his company doesn’t “have a ‘for sale’ sign up,” an answer to speculation from analysts that Bristol- Myers is a potential takeover target.

Cornelius needs to speed new drugs to market to fill a revenue hole Bristol-Myers will face in 2012 when generic copies of its top-selling Plavix blood thinner become available. He has been narrowing the company’s focus to biotechnology and pharmaceuticals and disposing of other operations. Since 2007, Bristol has acquired nine companies developing treatments for cancer, immune disorders and pain.

“There is $10 billion of real cash in the bank so we have the flexibility and the speed to get these deals done,” he said. “We are out hunting and we will see what we can get done.”

Source:http://www.bloomberg.com/apps/news?pid=20601103&sid=aqBFvInwsJ3Y

It is time to stand up to the Global Pharmaciticals.

Please sign the petition.

Thank you


Take Care,

Jimmy B

Bristol-Meyer Squibb, Tight Lips Sink Ships..Melanoma..Jim Breitfeller

Bristol-Meyer Squibb, Tight lips sink Ships

Bristol-Meyer Squibb can donate to the Disaster Relief in Haiti, But can’t donate to the citizens in the United States that need it the most, the Melanoma Cancer Patients that are fighting for survival and don’t qualify for BMS’s Trials. These are the cancer patients that are falling through the Healthcare system cracks. Jumping on the band wagon to get some extra PR is not the way to try to bolster their image. I believe in helping Haiti, but also Charity should start at home. Are they doing to for Humanitarian reasons or is it a just a big brand recognition scheme? I believe it is for the PR.


What really happened with the Compassionate Drug care use for Melanoma Patients? They said as of 9-12-2008 that they had to stop the use because they were having trouble manufacturing it. I believe it was all a cover up. As of 9-12-2008 they have opened quite a few new Clinical Trials with Ipilimumab. Then they pointed to a new process. There is one problem I see here. It only takes 3 months to grow the antibodies. They already had the master seed vials from Medarex. It is a Batch fermentation process or a continuous feed process. At the most it should take 4 to 5 months with testing and Good GMP.


So about 18 months have elapsed since the stoppage and we still have no Compassionate Drug use. That means at least 3 to 4 batches were made. We confirmed at least one or two batches based on information from some Melanoma non-profit organizations.


Bristol-Meyer Squibb, Show Us the Patients, the Master Production Batch Record (MPBR) or Production Batch Record (PBR) for Ipilimumab



Bristol-Meyer Squibb, If there was truly a Shortage/problem in the production of Ipilimumab, the it would show up in the Master Production Batch Record (MPBR) or Production Batch Record (PBR).


They won’t respond because there was not incident. The reason they shut it down in my opinion was, they were loosing money giving it away. It was not in the plan “Sting of Pearls”, and since it was going to take longer to get it FDA approved, they wanted to stop the outflow of revenue.


As of 1-29-2010, I am still getting lip service from Bristol Meyer Squibb.


“In light of the previous demand, Bristol-Myers Squibb is committed to ensuring that a continuous supply of ipilimumab is available prior to the re-opening of compassionate use so there are no treatment interruptions for patients who initiate therapy. As you probably know, the manufacturing cycle time and testing of a biologic such as ipilimumab is more complex than what is traditionally seen with small-molecule synthetic chemical pills. For example, host cells need to be grown, the purification process requires several steps before the active pharmaceutical ingredient can be formulated and the complexities associated with the manufacturing process limit the amount of drug supply that can be produced at one time. For more information on the manufacturing of biologics, please visit the Biotechnology Industry Organization's website at: http://www.bio.org/healthcare/pmp/factsheet1.asp.


It doesn’t take a year and half to produce. It all comes down to power and Greed



It is taking way to long for this drug to come to market. It was discovered over 10 years ago by Dr. Jim Allison at USC.




Bristol Meyer Squibb Has not even filed for a BLA yet. Biological License Application
So we could be another year or two before they go infront of the FDA. Many Melanoma Patients will die in the meantime. It will be blood on the the Hands of Bristol-Meyer Squibb. Greed has over taken compassion.

Just look at the graphic they put up at one of their financial meeting. They know what they have.
They realize what they are holding in their Drug Pipeline.

Take Care,

Jimmy B

Reply Back From the FDA about Compassionate Use of Ipilimumab..Melanoma..Jim Breitfeller

Reply Back From the FDA about Compassionate Use of Ipilimumab

Dear Jim:

Thank you for writing to the Food and Drug Administration (FDA). This is in response to your electronic inquiry dated November 10, 2009, to Dr. Margaret Hamburg, Commissioner, concerning the access to ipilimumab for compassionate use. Your letter was forwarded to my office in the Center for Drug Evaluation and Research (CDER) for a response.

Apparently, the drug's sponsor (BMS) has suspended their Treatment investigational new drug application (IND) because of inadequate supply of the drug. All of their production is being funneled to their clinical trials.

There were a number of individual patient protocols providing treatment access outside of the clinical trials. FDA and the company worked together to consolidate the individual INDs into a Treatment IND, but then found that demand was outstripping supply.

So, currently, there is apparently no expanded access program ongoing. FDA does not have authority to require the company to provide the product outside of their trials. Generally, it's more advantageous to dedicate limited product to clinical trials to establish safety and effectiveness and get the drug to market to provide the widest patient access.

Unfortunately, the FDA cannot readily affect a company's decision to provide patients with continued access under the Treatment IND.

The only real option is to contact the sponsor to convince them to consider reinstating an access program for desperately ill patients. The agency can make the regulatory pathway to access available, but the decision to produce and distribute the product lies solely with the sponsor.

Wish we could have been more help.

Sincerely,

Donald Dobbs
Consumer Safety Officer
Division of Drug Information
Office of Communications
Center for Drug Evaluation and Research


So we must put the Pressure on the sponsor, Bristol-Meyer Squibb

Take Care,

Jimmy B

Bristol Myers Squibb to pay 515 million to Settle Fraud Charges 2007 Melanoma..Jim Breitfeller

Shortage of Ipilimumab, I don't think so. I think it was staged to save and revert the drug to other Clinial trials. That is my opionion. Go to Clinical Trials. In the search field, type, Ipilimumab, Melanoma, protrate cancer, breast cancer,colon cancer, liver cancer. Then see when the trials that are recruiting and start date.

If it is after 8-12-2008, then the clinical trials was started with Ipilimumab after they took away compassionate drug use for the Melanoma Patients and is unethical to say the least.



Drugs giant Bristol-Meyers Squibb and a former subsidiary have been hauled over the coals and forced to pay more than half a billion dollars to settle settle federal and state investigations for promoting an anti-psychotic drug, Ablify, for uses that were not approved by the US Food and Drug Administration and providing illegal inducements to doctors and other health care providers.

The inducements included consulting fees and all expenses paid trips to resorts to attend conferences. There were also allegations that Bristol-Myers Squibb was behind the submission of false or fraudulent claims to medicaid, Medicare and other federal health programs.

Bristol Myers Squibb_pinged_515_million_to_settle_fraud_charges





Take Care,

Jimmy B

If you believe what Bristol-Meyer Squibb is telling us about the shortage watch This.Melanoma..Jim Breitfeller

Ex Drug Rep -- Manipulating Doctors

If they can manipulate Doctors, just think what they can do to the patients.

Watch the last two minutes.




Take Care,

Jimmy B

Man stands up for an ideal, or acts to improve the lots of others..Melanoma..Jim Breitfeller

Robert Kennedy said, "Few will have the greatness to bend history; but each of us can work to change a small portion of events, and in the total of all those acts will be written the history of a generation...it is from numberless diverse acts of courage and belief that human history is thus shaped. Each time a man stands up for an ideal, or acts to improve the lots of others, or strikes out against injustice, he sends forth a tiny ripple of hope, and crossing each other from a million different centers of energy and daring, those ripples build a current which can sweep down the mightiest wall of oppression and resistance."

This is a excerpt from a close friend from the Melanoma Community.

"Some of you have inquired about contacting administrators and clinical researchers both at Roche=BRAF and Bristol Myers Squib= Iplilmumab in order to have Bob get access to the clinical trials currently being done on Metastatic Melanoma. You are RIGHT ON! Indeed we must gather together and on behalf of Bob and so many more people we must contact these drug makers. Jimmy Breitfeller is a Carepage friend of ours who has beaten back his own beast of Metastatic Melanoma and has become a national advocate for those of us who are struggling with this disease. He is known as “The Melanoma Missionary” because of his daily dedication to cure of Melanoma. He has a petition that we can all sign entitled BMS COMPASSSIONATE INVESTIGATIONAL DRUG ACCESS. The electronic petition is located on his Blog

http://melanomamissionary.blogspot.com/ When you go to Jimmy's Blog you will read all his research and advocacy. This petition has taken his advocacy to a new level and it has been very effective in getting attention from the key decision makers at drug companies treating melanoma patients. It is critical for people like us to speak out and sign a petition to our government, whether it be the FDA or Congress and the Senate about the laws of Compassionate Care. Our officials need to be educated, especially when Healthcare is being debated RIGHT NOW in the Senate, and make the understand exactly what BIG PHARMA is doing correctly or NOT doing to help people who need access to medicine that might bring a cure to their diseases.

Day in and day out I read Carepages and talk to people who are at the end of their life. What I have learned from them and many of you who take the time to be updated on Bob's Journey is that we are all part of a much larger chain of life than we realize. Speaking only for myself, I have found internal happiness and joy when I have joined in the larger story, focusing less on myself and small issues and joining something wider. As you sign petitions and advocate for our loved one I think you will get a sense of what I feel on a daily basis working "the systems" to try gain access in order to find a cure for Bob's cancer. It is a kind of focus on our core purpose as a collective, which is to hand off a better world to the next generation, I find a deep sense of purpose. This is basically to say that some of the greatest joys and happiness these last 7 3/4 months has come from feeling in some small way together with Jimmy Breitfeller and many many many others we have contributed to making things better - especially for melanoma patients. What really does matter is how we treat each other.

Robert Kennedy said, "Few will have the greatness to bend history; but each of us can work to change a small portion of events, and in the total of all those acts will be written the history of a generation...it is from numberless diverse acts of courage and belief that human history is thus shaped. Each time a man stands up for an ideal, or acts to improve the lots of others, or strikes out against injustice, he sends forth a tiny ripple of hope, and crossing each other from a million different centers of energy and daring, those ripples build a current which can sweep down the mightiest wall of oppression and resistance."

Shabbat Shalom

I am proud to be a nanoparticle in this movement. See as particles get heated up, they move faster and faster. We start to collide with other things, this inturn starts everything into motion. Energy released from this motion may be in the form of heat. Heat can be good or bad. It just depends on which side you are on.

Please Join the movement. We owe it to all Cancer Patients around the world.

Take Care,

Jimmy B

This is why I am so upset.Melanoma..Jim Breitfeller

COPosted by Tim--MRF at 02:47 on Mon, Sep 28, 2009 [Show other posts by Tim--MRF](Melanoma Research Foundation)

In Reply to: Bristol-Meyer Squibb has a lot to Explain!! Ipilimumab compassionate use by Jim Breitfeller posted at 08:03 on Mon, Sep 28, 2009

Jim:

I have had the opportunity to meet with several people at BMS who are involved in ipi and can tell you that they share your frustration. The official word is that when they applied for compassionate use approval they underestimated the demand they would face. That plus the fact that people were surviving longer on the drug placed an unanticipated strain on capacity, resulting in suspending the compassionate use program. They have a new batch of ipi available, but are holding off on compassionate use until they are absolutely sure they have enough to fulfill the requirements of the clinical trials. I have heard that the trials are largely enrolled and that many trials have waiting lists. I have sent a note to the people I met at BMS and asked them two questions you raise: Why did the new batch take so long? And, when do they expect compassionate use to be re-opened? The word I had earlier was the first quarter of 2010. I will post again when and if I get a reply.

I have tried to encourage them to provide regular updates on status--people definitely want to know what is going on.

Tim

So why is the compassionate Use not first inline to get it?


It comes down to greed.They are looking after their bottom line but they preach:

What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life.”

All Lip Service!!!!!

THEY DID NOT EVEN HAVE THE DECENCY TO LET THE PATIENTS KNOW

Bristol-Meyer Squibb, LET YOUR TRUE COLORS COME SHINING THROUGH!!!!!!!

WHAT A BOONDOGGLE

THIS SHOULD BE REOPORTED TO THE FDA..CDER Drug Shortage Team

Take Care,

Jimmy B

Note to Bristol-Meyer Squibb,,Subject: TimeLine for compassionate drug use Ipilimumab.Melanoma.Jim Breitfeller

Subject: TimeLine for compassionate drug use Ipilimumab

It, has been over a year now that the compassionate drug use Ipilimumab was terminated due to production problems. As a chemist working in the field of biologics, I know it only takes about 3 months to generate Human Monoclonal antibodies. So why is it taking so long? I know you are trying different production protocols, but patients are loosing hope and their lives waiting for this drug. Will the compassionate use be reinstated soon? You say in your mission statement that:

“What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life.”

We need you Help Now!!!

Response:

Dear Mr. Breitfeller,

Thank you for your email.

As you are aware, Bristol-Myers Squibb and Medarex had to suspend enrollment of new patients into the compassionate use program and single patient exemptions to ensure treatment is not interrupted for patients currently receiving ipilimumab and to provide supply for ongoing clinical studies.

The manufacturing cycle time and testing of a biologic such as ipilimumab is complex. However, we are working through this process and continue to carefully manage the supply to enable the potential re-opening of compassionate use at the earliest possible time and when continuous supply is available. The companies recognize the great unmet medical need for patients with metastatic melanoma and remain committed to the development of ipilimumab.


Regards,


Bristol-Myers Squibb

Something doesn't seem right here. There is something going on. A year to get your Protocol in place that was already in place.

It doesn't smell right!!!!


I bet you it has something to do with the string of Pearls!!!!!!!!

Take Care,

Jimmy B

Remember I said Blame it on The Tregs??Melanoma..Jim Breitfeller

OX40 engagement and chemotherapy combination provides potent antitumor immunity with concomitant regulatory T cell apoptosis.

Published online May 4, 2009
doi:10.1084/jem.20082205
The Journal of Experimental Medicine, Vol. 206, No. 5, 1103-1116
The Rockefeller University Press, 0022-1007 $30.00
© 2009 Hirschhorn-Cymerman et al.


Hirschhorn-Cymerman Daniel; Rizzuto Gabrielle A; Merghoub Taha; Cohen Adam D; Avogadri Francesca; Lesokhin Alexander M; Weinberg Andrew D; Wolchok Jedd D; Houghton Alan N

The Journal of experimental medicine 2009;206(5):1103-16

Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA.

"Expansion and recruitment of CD4(+) Foxp3(+) regulatory T (T reg) cells are mechanisms used by growing tumors to evade immune elimination. In addition to expansion of effector T cells, successful therapeutic interventions may require reduction of T reg cells within the tumor microenvironment. We report that the combined use of the alkylating agent cyclophosphamide (CTX) and an agonist antibody targeting the co-stimulatory receptor OX40 (OX86) provides potent antitumor immunity capable of regressing established, poorly immunogenic B16 melanoma tumors. CTX administration resulted in tumor antigen release, which after OX86 treatment significantly enhanced the antitumor T cell response. We demonstrated that T reg cells are an important cellular target of the combination therapy. Paradoxically, the combination therapy led to an expansion of T reg cells in the periphery. In the tumor, however, the combination therapy induced a profound T reg cell depletion that was accompanied by an influx of effector CD8(+) T cells leading to a favorable T effector/T reg cell ratio. Closer examination revealed that diminished intratumoral T reg cell levels resulted from hyperactivation and T reg cell-specific apoptosis. Thus, we propose that CTX and OX40 engagement represents a novel and rational chemoimmunotherapy."

Abstract on PubMed

By depeting or changing the Treg ratio/compared to the CD8+ Tcells, one can theoretically shift the balance of the immune system to initiate an immune repsonse.

I will try to ge a copy of this paper


Take Care,

Jimmy B

It is Time to Have Our Voices Heard!!! Melanoma ..Jim..Breitfeller

Please go to Melanoma Missionary and write to your congress Person.

We need to get this movement started.

Dear Congressperson,
I am writing this letter to ask for your help. As a constituent in your district, we need you to act, vote and rally for this cause. The Health Care System is failing us. The Drug (Ipilimumab (MDX-010) is a fully human, monoclonal antibody that overcomes CTLA-4-mediated T-cell suppression to enhance the immune response against tumors) has been fast tracked by the FDA has not been available for compassionate use for almost a year now. The company Bristol Meyers Squibb says they are having trouble making it. We are questioning their ethics. We believe that they are holding back and inflating the demand or does it have to do with the FDA approval process. This seems to be corporate greed at its finest.

"Unfortunately, they also have some bad habits. For example, there were two anti-trust suits filed against them, for monopolizing the market in order to delay, or stop, the generic versions of the anti-cancer drug Taxol, and the anti-anxiety drug Buspar. The company was able to do this through manipulation of loopholes in the Hatch-Waxman Act. Under this act, brand name manufacturers list un-expired patents with the FDA in a listing, or compendium, known as the ?Orange Book?. This listing offers a reward of an automatic 30-month stay against certain potential generic entrants who have been sued for product infringement."

Source:http://www.academon.com/lib/essay/bristol-myers-squibb-company.html

Right now they have the monopoly on this monoclonal Antibody.

Compassionate Use Trial for Unresectable Melanoma With Ipilimumab (IMEXA)This study has been suspended.

First Received: June 29, 2007 Last Updated: June 17, 2009 Sponsored by: Bristol-Myers SquibbInformation provided by: Bristol-Myers SquibbClinicalTrials.gov Identifier: NCT00495066

We are asking for a Congressional Investigation into this matter.

As you know 64,000 will be diagnosed with this terrible disease, and about 8400 will die this year alone in the U.S.
One in three will be touched by cancer in their lifetime, you may be the next.

Please don’t let it fall on deaf ears. Our life depends on your help.
Sincerely,

=========================================================
Here is what Bristol Meyer Squibb says about themselves:

"What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life."

What sets them apart is:
Corruption at the Top!!!!!

"You remember the case: Andrew Bodnar, former Senior EVP at Bristol, pleaded guilty to a single count of lying to the FTC to hide a secret deal with Canadian generics maker Apotex. Bristol had promised Apotex that it wouldn't interfere with future generic sales, provided the copycat drugmaker agreed to postpone launching its version of Plavix. The FTC objected to that deal as, in effect, a pay-for-delay agreement. Bodnar excised that provision from Bristol's agreement with Apotex--but he made an oral promise to the generics maker, the government said. Bodnar denied it; he was charged with the crime."

Source:http://www.fiercepharma.com/story/ex-bms-exec-sentenced-write-plavix-book/2009-06-09


Take Care,

Jimmy B

Compassionate Drug Use for You and Me.. Melanoma..Jim Breitfeller

"Compassionate Drug Use

What is compassionate drug use?

Medical professionals use the term “compassionate use” to refer to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available. Drugs that are being scientifically tested but have not yet been approved by the United States Food and Drug Administration are called investigational drugs. Access to one of these drugs when you are not in a clinical trial has many names, but is most commonly referred to as compassionate use.

Is compassionate drug use legal?

Compassionate drug use is legal, but it is tightly restricted to people who meet certain conditions. The FDA first approved investigational drugs to be used in this way for critically ill patients in 1987. There are 2 ways a drug company commonly gives access to their unapproved drug to a person who is not in a clinical trial:


expanded access program (EAP)
single patient access
A company sponsoring a drug in the late stages of drug development, including Phase III clinical trials, can offer expanded access programs for patients who are not able to enroll in a clinical trial. The FDA generally approves these programs if the drug has shown some effectiveness against a specific cancer in the clinical trials that are being done.

Patients who are not eligible for either clinical trials or an expanded access program (if one exists) may be able to get the unapproved new drug by applying for single patient access. In this case, the patient's doctor must first request permission for access to the drug from the drug company. If the company agrees, the patient's doctor works with the drug company to ask the FDA to approve the drug for use by this one patient. The length of time it takes to get single patient access varies. But if it is an emergency, the FDA can complete the paperwork in 24 hours.

Why are compassionate drugs used?

Compassionate drug use is mostly obtained for patients with advanced disease who have tried all of the available treatment options and whose disease has not responded, or for patients with diseases that have no approved treatment options and no clinical trials that meet the patients' needs. There must also be reason to expect some benefit from the investigational drug. In cases such as these, the doctor may consider trying to get a new, unapproved drug for a patient who is not in a clinical trial.

What problems are associated with compassionate drug use?

Perhaps the biggest problem with compassionate drug use is that it is hard to get. The simplest way to get access to an unapproved drug is through a clinical trial. But many people with life-threatening diseases either cannot find suitable clinical trials, or they live far from cancer research centers, or they are not eligible for any studies being done.

Expanded access programs (if offered by the drug company) or access through single-patient compassionate use is possible for some. But working out single-patient compassionate use of an unapproved drug is often time-consuming and frustrating. For instance, there is no single policy or process followed by the FDA and drug companies. As of 2007, no one publishes a list of all the drugs that are available through compassionate use in the United States. There is no way to require the drug company to supply the drug. Producing extra medicine for people who are not in clinical trials can be expensive for the drug company, especially since there is a chance the drug will not be approved.

Compassionate drug use can also be very confusing. There are several programs that regulate it. There are many terms and definitions that are used to describe how a patient may get access to an unapproved, new drug outside of a clinical trial. Drug companies, patient advocacy groups, and the FDA all may use different terms for the same things. For example, the terms used by the FDA are defined in their regulations, while most drug companies refer to their compassionate access programs with terms that are unique to their specific programs and not in line with the FDA language"

Source:http://www.cancer.org/docroot/ETO/content/ETO_1_2x_Compassionate_Drug_Use.asp

Compassionate Drug Use


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Jimmy B