Monday, January 31, 2011

Expanded access With RO5185426 in Patients With Metastatic Melanoma..Jim Breitfeller

Expanded access With RO5185426 in Patients With Metastatic Melanoma.
The locations are limited.

The drug is called RO5185426, which is interchangeable with PLX4032 and RG7204. Also, you must be Braf positive and failed a prior therapy.

Expanded access With RO5185426 in Patients With Metastatic Melanoma

“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


Saturday, January 29, 2011

CEL-SCI on cusp of cancer game-changer Melanoma..Jim Breitfeller

This Cytokine Therapy may be helpful prior to Anti-CTLA-4 Blockade (Ipilimumab)or after. It may help send the Danger signal to involke the immune response.

CEL-SCI on cusp of cancer game-changer

“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


Monday, January 24, 2011

MSKCC to Test Agenus' Personalized Cancer Vaccine in Combination With Novel Immunomodulatory Agents Melanoma..Jim Breitfeller

MSKCC to Test Agenus' Personalized Cancer Vaccine in Combination With Novel Immunomodulatory Agents

LEXINGTON, Mass., Jan. 24, 2011 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN) today announced it has entered into a research agreement with Memorial Sloan-Kettering Cancer Center (MSKCC) using Agenus' proprietary cancer vaccine technology.

The collaboration will test Agenus' cancer vaccine in combination with antibodies that are intended to target specific markers on tumor cells, such as CTLA-4 and PDL-1. This group of antibodies represents a new class of immunotherapeutic agents that are thought to have complementary mechanisms of action with cancer vaccines. The studies will be performed in the laboratory of Jedd D. Wolchok, M.D., Ph.D., a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Associate Director of the Ludwig Center for Cancer Immunotherapy at MSKCC as well as Director of Immunotherapy Clinical Trials.

"Collaborating with MSKCC and Dr. Wolchok's laboratory opens a new chapter in the development of our personalized cancer vaccine portfolio for targeting later stages of this disease," said Garo Armen, Ph.D., CEO of Agenus. "Partnerships with leading institutions are central to Agenus' strategy to bringing life-changing products for cancer patients to market faster."

Agenus' cancer vaccine is designed to expand and specifically program the army of T-cells responsible for killing tumor cells; however, as cancer grows it becomes smarter and increasingly builds an 'immune fortress' that can protect itself from the attack of T-cells. Therefore, combining a product that activates T-cells with an agent that blocks the signal preventing the T-cells from effectively killing the tumor could have highly potent outcomes.

"Combination immunotherapy in cancer is increasingly becoming a key focus of research, and this collaboration will add to this important and growing knowledge base," said Dr. Wolchok. "Our interest in Agenus' cancer vaccine is that it contains many antigens that are genetically matched with the cancer as the product is derived from the tumor itself."

"In addition to this preclinical research effort, we are looking forward to opportunities to rapidly initiate clinical trials, combining our Prophage series of cancer vaccines with either marketed or investigational agents that work against T-cell down regulation," said Dr. Armen.

Source:Personalized Cancer Vaccine in Combination With Novel Immunomodulatory Agents

Combinatorial therapy will lead us toward a cure. Mark my words.

“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

Saturday, January 15, 2011

Gene Therapy Eliminates Brain Tumors Through Selective Recruitment Of Immune Cells..Melanoma Jim Breitfeller

Gene Therapy Eliminates Brain Tumors Through Selective Recruitment Of Immune Cells

“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

Thursday, January 13, 2011

Alarmins Initiate Host Defense against Melanoma, Let the war games begin..Melanoma ..Jim Breitfeller

The immune system has evolved to respond not only to pathogens, but also to signals released from dying cells. These signals are generated by molecules call Alarmins.
In response to infection and/or tissue injury, cells of the host innate immune system rapidly produce a variety of structurally distinct mediators that not only function as potent effectors of innate defense but also act to alarm the immune system by promoting the recruitment and activation of host leukocytes through interaction with distinct receptors. One of these Alarmins is the High mobility group box 1 (HMGB1).

(HMGB1) is a DNA-binding nuclear protein, released actively following cytokine stimulation as well as passively during cell death; it is the prototypic damage-associated molecular pattern (DAMP) molecule and has been implicated in several inflammatory disorders, but our case, it is the molecule that sends the red flag up to the immune system, stating there is a problem.

This Alarmin (HMGB1) is capable of activating antigen-presenting cells (APCs) and enhancing the development of antigen-specific immune responses.

The interaction of high mobility group box 1 protein (HMGB1) released from dying tumor cells with Toll-like receptor 4 (TLR) on dendritic cell was required for the crosspresentation of tumor antigens and the promotion of tumor specific cytotoxic T-cell responses.

Under stress conditions, such as injury or infection, HMGB1 is released and promotes inflammation. (Danger Signal) HMGB1 is passively released by Death of cells or tissues through injury or disease (necrotic) but not apoptotic death. Disintegration of cells into membrane-bound particles that are then eliminated by phagocytosis or by shedding of normal cells and actively secreted by a variety of activated immune and non-immune cells.
Through the TLR4, HMGB1 activates NFκB inducing a wide range of host changes that include activation of the innate immune system (neutrophils, NK cells, dendritic cells) and secretion of proinflammatory cytokines and mediators.

There is growing evidence that the relationship between the inflammatory process and cancer is complex. Our understanding of this relationship as it relates to Danger Signal development and or progression of malignancy is still limited. Further evaluation in patients is clearly needed if we are to truly understand whether there is therapeutic potential in targeting Pro-inflammation, “The Danger Signal”.

HMGB1 as a DAMP released into the tumor microenvironment plays a central role in the recruitment and activation of innate immune cells.

This emergent understanding of the danger signals also called alarmins or damage associated molecular patterns (DAMPs) is fueling new research that may be beneficial to finding a cure.

This ability of dendritic cells to recreate the environment associated with necrosis via the regulated secretion of HMGB1 represents a successful evolutionary strategy and places HMGB1 at the crossroads between innate and adaptive immunity.

Once T-cells are activated, RAGE and HMGB1 are upregulated during cellular activation, consistent with a role of the RAGE axis in pro-inflammatory immune responses.

So how do we cause tumor cells to die? We don’t need to kill them all at once, that would be nice, and we need to a portion so that HMGB1 is secreted. Or do we inject a mixture of naturally occurring Cytokines that act as the pro-inflammatory cytokines, (the Danger Signal)?

A little known company is just doing that. The company is IRX Therapeutics.

Irx Therapeutics, Inc
2350 Broadhollow Road
Farmingdale, NY 11735-1006

Dr. John W Hadden founded the company in 1994 and holds the patent on the cytokine mixture called IRX-2.

The cytokine components of IRX-2 (includes IL-1, IL-2, IL-6, IL-8, IFN-γ, TNF-α, G-CSF and GM-CSF) are known to promote both T lymphocyte and dendritic cell development and function and monocyte function.

I believe the natural cytokine mixture (NCM). The NCM includes 1L1, IL2, IL6, IL8, IL10, IL12, .delta.IFN, TNF.alpha. and G- and GM-CSF could play a pivotal role in activation of the T-cells (CD4+ and CD8+). This mixture that is in the patent (20030206885) is what I would call the Proinflammatory Cytokines, the “Danger Signal”.

The natural cytokine mixture is missing MCP-1, MIP-1 alpha and beta which is very important to attract immune cells to the tumor’s microenvironment.

CCL3/MIP-1 alpha acts as a chemoattractant to a variety of cells including monocytes, T cells, Dendritic cells, B cells and eosinophils

CCL4/MIP-1 beta is expressed primarily by T cells, B cells, and monocytes after antigen or mitogen stimulation. The functional receptor for MIP-1 beta has been identified as CCR5.

CCL4, also known as macrophage inflammatory protein 1 beta (MIP1β)
is a 7.8 kDa β chemokine that is secreted at sites of inflammation by activated leukocytes, lymphocytes, vascular endothelial cells.

CCL4 attracts a variety of immune cells to sites of microbial infection as well as to other pathologic inflammation.

Monocyte chemoattractant protein-1 (MCP-1) is important in attracting monocytes to sites of inflammation. Besides induction of monocyte recruitment, MCP-1 can also affect chemotactic response of endothelial cells.

I speculate by combining Radiation, Chemotherapy, Ipilimumab, IRX-2, and IL-2 in a systematic way, we can induce an immune response against Melanoma and win most of the Battles. Let the war games begin. Who will take on this challenge and be the first to CURE Melanoma? We shall see.

A clue: This is from a patient that is receiving Ipilimumab (Yervoy)

“The Dr. says it's possible the swelling is caused by the tumors starting to respond. My back and leg tumors did become inflamed before they receded, so it's possible the same is happening in the brain. I could also be having a delayed reaction.”

From a paper of Dr. Meenhard Herlyn.

Inflammation is the key to the Danger Signal which can be produced by dying Tumor cells or Ipilimumab differentiating T-cells into Th-17 Phenotype or by injecting a pro-flammatory cytokine mixture. Let the War on Melanoma Begin!!!!!

“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

Thursday, January 6, 2011

BMS denies any wrongdoing. Is this what we have to look forward to with Yervoy (Ipililumab) Melanoma..Jim Breitfeller

BMS denies any wrong doing, but this was not it's first offence and may not be it's last. As the patent waterfall nears close with Plavix, is BMS trying to make up for it's loss of revenue?
Mesothelioma and Cancer Patients Who Received Certain Chemotherapy Drugs May be Eligible for Reimbursement

I am anticipating that BMS will try to inflat the cost of production of Ipilimumab (Yervoy) and try to pass it along to the patients that desperately need it. It is a shame that the drug companies have come down to greed and screw the consumer. BMS needs desperately to clean house again and go through some Ethics training, Big time!!!

I am all for paying a fair price, but not to get gouged to the point that the insurance won't pay and pass the copay onto the patients. It is not right.


Bristol Myer Slogan:

"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."

So we can deplete your life savings for the good of the company and line our pockets!!!!

“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

Wednesday, January 5, 2011

Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is cancelled. Ipilimumab (Yervoy)

Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is cancelled. Ipilimumab (Yervoy)

Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Page 81283]
From the Federal Register Online via the Government Printing Office []
[FR Doc No: 2010-32413]



Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Oncologic Drugs Advisory Committee; Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The meeting of the Oncologic Drugs Advisory Committee
scheduled for February 9, 2011, is cancelled. This meeting was
announced in the Federal Register of December 6, 2010 (75 FR 75680). On
February 9, 2011, the Oncologic Drugs Advisory Committee was scheduled
to discuss biologics license application (BLA) 125377, with the
proposed trade name YERVOY (ipilimumab), submitted by Bristol-Myers
Squibb Co. The proposed indication (use) for this product is for the
treatment of advanced melanoma in patients who have received prior
therapy. This meeting has been cancelled because the issues for which
FDA was seeking the scientific input of the committee have been

Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, e-mail:, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), and follow the prompts to the desired center
or product area. Please call the Information Line for up-to-date
information on this meeting.

Dated: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-32413 Filed 12-23-10; 8:45 am]

“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


Greetings to One and All

This Blog is dedicated My Brother Kenny B. who passed away in the late 1970's with Cancer before the Internet.

It was he, who showed me How to live and give back. He was wise beyond his years.

Kenny B

Jimmy and Dee

Carepage: Jimmybreitfeller
Jimmy Breitfeller

My Profile as of 2009

My photo
Last July (2005)I was riding my bicycle to work at the Eastman Kodak Research Labs about 3 miles from home. I was wearing a knapsack to carry my things to and from the labs. I started noticing an ache on my back. So I decide to go to the dermatologist. To make the long story short, it was cancer. I knew from my research that I would be needing adjuvant therapy. So I started communicating with Sloan Kettering, University of Pittsburgh Cancer Center, and a couple of others including the Wilmot Cancer Center at Strong. I realized that by telling my story, I might help someone else out there in a similar situation. So to all who are linked by diagnosis or by relation to someone with melanoma, I wish you well. Stay positive, read as much as you can (information helps to eliminate the fear associated with the unknown), and live for today, as no one can predict what tomorrow may bring. Jimmy B. posted 12/15/08


The information contained within this Blog is not meant to replace the examination or advice of your Oncologist or Medical Team. The educational material that is covered here or Linked to, does not cover every detail of each disorder discussed.

Only your physician/Oncologist can make medical decisions and treatment plans that are appropriate for you. But, An Educated Consumer is a Smart consumer.

As Dr. Casey Culberson Said:

"The BEST melanoma patient is an ACTIVE PARTICIPANT in his or her treatment

Melanoma and the “Magic Bullet” (Monoclonal Antibodies)

Just to let you know I posted the first draft of the Melanoma and the “Magic Bullet” (Monoclonal Antibodies). on Melanoma Missionary In the Shared File Section. you can download it for 19.95 (Only kidding) it is Free for the taking.

It is 33 pages long and may help you in your quest for the Yellow Brick Broad. Just to let you know it is only the first draft. Revisions are sure to come. I wanted to get it to the people that need it the most, the Melanoma Patients.


So, where does Interluekin-2 (IL-2) come into play? According to Byung-Scok et al and recent reports, IL-2 is not needed for developmental CD4+ CD25+ Treg cells in the thymus but does play an important role in the maintenance and function in the peripheral.18 Peripheral is defines as secondary system outside the bone marrow and thymus. It entails the site of antigen, immune system interaction. IL-2 is required for the peripheral generation of Tregs based Abbas’s and colleagues research.19

IL-2 prevents the spontaneous apoptosis of the CD4+ CD25+ Treg cells. It has been reported that patients with multiple advance-stage tumors have elevated levels of Tregs within the tumor microenviroment.20 Interluekin-2 is the survival factor for CD4+ CD25+ Treg cells.21 If the addition of IL-2 is on or before the maximum propagation of the CD4+ T cells, the Tregs population can increase 5-fold in a 96 hour period based on certain growth mediums.

By controlling the addition of the endogenous IL-2, one has a knob to turn and can lead to the control of the expansion of the Tregs. When you combined this control with the anti-CTLA-4 blockage, you can shift the balance of the immune response.

Now here is the catch. The maintenance and function of the CD8+ T-cells require CD4+ cells which secrete IL-2. So we don’t want to deplete the CD4+ cells, we want to control the expansion of the Tregs which are a subset of the CD4+ cells. It has been postulated by some researchers that the Anti-CTLA-4 blockage also suppresses the Treg function in a different mechanism. By using IL-2 as the rate limiting factor, we can suppress the CD4+ CD25+ Treg cell expansion by controlling the concentration and timing of the Inerluekin-2 at the tumor microenvironment.

The Interluekin-2 plays another role in this Melanoma Maze. In a study by Janas et al, Il-2 increases the expressions of the perforin and granzyme A, B and C genes in the CD8+ T-cells. This increase expression causes the CD8+ T-cells to mature into Cytoxic T Lymphocytes (CTLs). The exogenous IL-2 is required for the granzyme proteins. As stated previously, CTLs have cytoplasmic granules that contain the proteins perforin and granzymes. A dozen or more perforin molecules insert themselves into the plasma membrane of target cells forming a pore that enables granzymes to enter the cell. Once in the tumor cell, these enzymes are able to breakup (lyse) the cell and destroy it. This is the beginning of the end for the cancer cells. The tumors begin to shrink and the rest is history,

On the other hand, prolong therapy with Il-2 can result in causing apoptotic death of the tumor- specific CD8+ T-cells.23

Clearly in a clinical setting, timing, dose, and exposure to these drugs play a major roll in the immunotherapy, and can have dramatic effects on the outcome.

All it takes is that one magic bullet to start the immune reaction..

Melanoma And The Magic Bullet (Monoclonal Antibodies)

Public Service Announcement

A call for Melanoma Patients by Dr. Steven A Rosenberg

"We continue to see a high rate of clinical responses in our cell transfer immunotherapy treatments for patients with metastatic melanoma", Dr. Rosenberg said.

"We are actively seeking patients for these trials and any note of that on a patient-directed web site would be appreciated."

If you would like to apply for his trials, here is the website and information.

Dr. Rosenberg's information

Dr. Rosenberg's Clinical Trials

For the Warriors

The Melanoma Research Alliance has partnered with Bruce Springsteen, the E Street Band, and the Federici family to alleviate suffering and death from melanoma. Please view Bruce Springsteen’s public service announcement inspired by Danny Federici. Danny was the E Street Band’s organist and keyboard player. He died on April 17, 2008 at Memorial Sloan-Kettering Cancer Center in New York City after a three year battle with melanoma.

Source Fastcures blog

Join the Relay for Life!!!


Dear Family and Friends,

I’ve decided to take a stand and fight back against cancer by participating in the American Cancer Society Relay For Life® event right here in my community! Please support me in this important cause by making a secure, tax-deductible donation online using the link below.

To donate on line now, click here to visit my personal page.
Jimmy B AKA Melanoma_Missionary

Relay For Life® is a life-changing event that brings together more than 3.5 million people worldwide to:

CELEBRATE the lives of those who have battled cancer. The strength of survivors inspires others to continue to fight.

REMEMBER loved ones lost to the disease. At Relay, people who have walked alongside people battling cancer can grieve and find healing.

FIGHT BACK. We Relay because we have been touched by cancer and desperately want to put an end to the disease.

Whatever you can give will help - it all adds up! I greatly appreciate your support and will keep you posted on my progress.

Keep the Fire Burning!!!



Jimmy Breitfeller
Turn off Music before you "Click to Play"
Signs of Melanoma Carcinoma Skin Cancer

How Skin Cancer Develops by " : Dermatology"

Call for Patients with Unresectable Liver Metastases Due to Melanoma

Delcath Systems Granted Orphan-Drug Designations for Cutaneous and Ocular Melanoma

Delcath is actively enrolling patients in a Phase III clinical trial testing its proprietary drug delivery system, known as Percutaneous Hepatic Perfusion (“PHP”), with melphalan for the treatment of ocular and cutaneous melanoma metastatic to the liver.

This NCI-led trial is enrolling patients at leading cancer centers throughout the United States. Commenting on these orphan-drug designations, Richard L. Taney, President and CEO of Delcath, stated, “These favorable designations are important steps in our efforts to secure Delcath’s commercial position upon conclusion of our pivotal Phase III trial for metastatic melanoma. We remain steadfast in our commitment to become the leader in the regional treatment of liver cancers and we continue to enroll patients in this study, and advance our technology and the promise that it offers to patients with these deadly forms of melanoma and other cancers of the liver, all with limited treatment options.”

Orphan drug designation, when granted by the FDA’s Office of Orphan Products Development, allows for up to seven years of market exclusivity upon FDA approval, as well as clinical study incentives, study design assistance, waivers of certain FDA user fees, and potential tax credits.

Current Trial Centers

Phase I Study of Hepatic Arterial Melphalan Infusion and Hepatic Venous Hemofiltration Using
Percutaneously Placed Catheters in Patients With Unresectable Hepatic Malignancies

James F. Pingpank, Jr., MD, FACS
Associate Professor of Surgery
Division of Surgical Oncology
Suite 406, UPMC Cancer Pavillion
5150 Centre Avenue
Pittsburgh, PA 15232
412-692-2852 (Office)
412-692-2520 (Fax)

Blog Archive

Call For Melanoma Patients!!!!

Call For Melanoma Patients!!!!

Dr. Rosenberg Has a New Clinical Trial.

Our latest treatment has a 72% objective response rate with 36% complete responses.

We are currently recruiting patients for our latest trial.

Is there some way to post this “Call for Patients” on the web site?

Steve Rosenberg

Dr. Rosenberg's Clinical Trials

(For a copy of the research paper.. see My Shared files)

The news headlines shown above for Melanoma / Skin Cancer are provided courtesy of Medical News Today.