Cdx-110

[Enviro Girl]

OK, Baraka, anything 4 U - but what is NEE?

The C Word? The Pf word?

[Baraka Obam]

YouTube - Knights Who Say Ni

[Enviro Girl]

Wow CC, that was some read! Thanks and Send More! U rock!

BO: It look like a lot of NEE is going to get NEEd from various natural resources!

Whoop-NEE!

[Enviro Girl]

So, CC - do you think that drug in your article is the same as the CDX-100 or a different mfg or ?

[Enviro Girl]

The Preston Robert Tisch Brain Tumor Center at Duke :: Cross hairs on a cancer - BTC - News

BTC : Cross hairs on a cancer
Posted by pam on 2008/1/18 13:58:00 (36001 reads)
An experimental brain tumor vaccine coaxes the immune system to attack diseased cells only. Trials on othercancers may follow.
By Bruce Goldman Special to The Los Angeles Times
January 14, 2008


CANCER patients and physicians are always looking for therapies free of side effects. But the standard treatments available to them—chemotherapy and radiation—typically work via a shotgun approach, indiscriminately killing all rapidly dividing cells whether they're cancerous or not. A long-held notion that the immune response might, in some practical manner, be harnessed to target cancer cells while sparing the rest is now being put to the test.

An experimental vaccine is now in multi-center, late-stage trials for treatment of glioblastoma, the most common brain cancer in adults. If the therapy lives up to its promise, it could potentially be used for other cancers as well.

Glioblastoma, which strikes more than 10,000 adults per year in the United States, is a particularly aggressive form of brain cancer: Only one-half of patients survive for one year, even after radiation treatment and surgery to remove as much of the tumor as possible. The recent introduction of temozolomide, a chemotherapeutic drug, to the arsenal has added barely two months of survival to patients' lives.

Normally, we think of vaccines as prevention measures that enable our immune systems to pounce on bacteria or viruses the minute they strike. In this case, however, the new vaccine -- which goes by the experimental name CDX-110 -- is designed to kick-start an immune assault on an existing tumor.

So far, CDX-110 has been administered to almost 70 people, with virtually no side effects, according to Dr. John Sampson, a neuro-oncologist and brain surgeon at Duke University in Durham, N.C., who has been working on the vaccine.

The vaccine is designed to treat a certain subtype of glioblastoma that is present in 25% to 40% of cases. Tumors of this sub-type have a mutant protein known as EGFRvIII studded on the surface of many of their cells -- a twisted variant of a normal protein called EGFR. The normal EGFR is widely distributed on cells in the body and will stimulate division of the cell when it receives the correct hormone signal.

The mutant protein EGFRvIII, however, has an altered structure that sticks it in the "on" position permanently -- relentlessly triggering cell division, causing out-of-control, cancerous growth. Glioblastoma patients testing positive for EGFRvIII have a bleaker prognosis than those who don't. Virtually no EGFRvIII-positive patient survives two years, versus about 15% of those who are negative.

But there's an upside. The very uniqueness of the EGFRvIII protein has allowed scientists, in theory, to design a vaccine against tumor cells and only tumor cells.

The vaccine, designed by Sampson and Dr. Amy Heimberger, a brain surgeon at the M.D. Anderson Cancer Center in Houston, is fairly simple: It consists of a small fragment of EGFRvIII with a slight structural modification plus a couple of substances known to enhance the immune response. The theory: The body's immune cells, after being exposed to this protein, will launch an attack on EGFRvIII-positive cells but -- unlike chemotherapy or radiation -- will spare hair, skin, intestinal lining and immune cells.

In a just-completed study led by Sampson and Heimberger, 23 glioblastoma patients underwent radiation treatment and then surgery to excise all but traces of their tumors, followed by a single dose of the anti-tumor drug temozolomide.

Next, they received three biweekly injections of the experimental vaccine. Vaccine injections were continued monthly until patients' tumors returned, as they almost invariably do.

The results, which are not yet published, were encouraging, Heimberger says. Half of the patients survived for more than 30 months after treatment, versus the 12 months expected for patients treated only with radiation and surgery. And 65% were still alive after two years, compared with the almost-zero two-year survival rate predicted for this class of patient. Several have survived more than three years, Heimberger adds.

Typically, tumors recur within six months in patients given standard treatment, but with vaccine treatment, recurrence was delayed almost 15 months, Sampson says.

CDX-110 is not the only cancer vaccine in clinical trials, but it may be the first truly tumor-specific one that can be easily mass-produced. (A few other "personalized" vaccines, which aim at protein targets that differ from one patient to the next, are also under clinical investigation, but identifying and manufacturing vaccines on a one-off basis is inherently costly.) The prospect of a first-ever "off the shelf" cancer vaccine applicable to large numbers of patients has drawn the attention of investors as well as investigators.

Celldex Therapeutics, a New Jersey-based biotechnology company that has licensed rights to the vaccine from its Duke inventors, is sponsoring a larger, randomized clinical trial of 90 glioblastoma patients. Enrollment is underway in nearly a score of medical centers across the U.S., with UCLA planning to start enrollment Wednesday, and UC Irvine and USC further down the road. (For a list of centers recruiting patients, see About Celldex).

If CDX-110 continues to slow the return of patients' tumors, the trial will expand to a 360-patient clinical study to more thoroughly test the treatment's promise, says Tom Davis, chief medical officer of Celldex.

The vaccine may prove useful in more than just treatment of glioblastoma, Davis says, because the abnormal protein EGFRvIII turns up in several other tumor types, including cancers of the breast, lung, head and neck. A success in glioblastoma could thus portend a similar vaccine approach to these cancers as well, although trials for those other cancers won't take place until a large-scale, controlled glioblastoma clinical trial has reported success.

Sampson and Heimberger caution that the therapy, although promising, is not a panacea. Sooner or later, solid tumors typically evolve sophisticated mechanisms to shut down the immune response, meaning that only very early-stage patients or those whose tumors have been all but eliminated by surgery can hope to benefit from the vaccine.

Even a successful vaccine won't be applicable to the majority of glioblastomas that are EGFRvIIIfree, Heimberger says. And even if they are applicable, most patients' conditions still eventually worsen, because EGFRvIII-positive glioblastomas also contain other cells that aren't killed by the vaccine.

But getting rid of EGFRvIII cells seems to take some of the fight out of whatever tumor cells do remain, slowing their return. And the extra time is precious. In 2002, a diagnosis of brain cancer forced Amy Pomykal, then Mrs. Dallas County, out of the Mrs. Texas pageant. "They told me, 'Go home and have a good life for a couple of months until you die,' " says the American Airlines flight attendant. Her search for a better prognosis led her to volunteer in 2003 for the early-stage vaccine trial.

Four-and-a-half years later, with an 18-month-old son at home and another child due in March, she is not only disease-free, according to her twice-yearly brain scan, but working extra hours at the airport. She says her only restrictions are scuba diving and roller-coaster riding -- a prohibition she breaks annually at the Texas State Fair.

[Enviro Girl]

Cdx-110 - Types of Cancer - Zimbio

Cdx-110
EmailWritten by frankybme on Mar-5-10 7:15pm
From: morgellons-disease-research.com
Is this the 'Smart' Bomb Cancer drug I'm hearing sudden media fuss about? Timing seems funny...
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News Article

NEW YORK—Pfizer Inc. has struck a deal with DxS, a wholly owned subsidiary of QIAGEN, for a companion diagnostic test kit that will be used alongside a new brain tumor drug.

That drug, Pfizer’s PF-04948568 (CDX-110), is an immunotherapy vaccine for treating newly diagnosed glioblastoma multiforme (GBM), the most common malignant primary brain tumor in adults—occurring in around 25,000 patients worldwide each year. CDX-110 is a peptide vaccine which targets the tumor-specific Epidermal Growth Factor Receptor variant III (EGFRvIII), a mutated form of the epidermal growth factor receptor that is only present in cancer cells and occurs in 25 to 40 percent of GBM tumors.

Pfizer and Celldex Therapeutics Inc. signed an agreement in 2008 granting Pfizer an exclusive worldwide license to CDX-110, which is currently in Phase II clinical development. Pfizer is also exploring lifecycle opportunities for CDX-110 in other tumor types expressing the EGFRvIII mutation.

The diagnostic being developed in the Pfizer-DxS deal will be a real-time PCR assay used to detect EGFRvIII RNA in tumor tissue. The EGFRvIII companion diagnostic will be developed and manufactured at QIAGEN’s Center of Excellence for Companion Diagnostics in Manchester, U.K. The assay is designed to offer a simple workflow, which supports its clinical utility in routine mutation testing.

In a statement, Pfizer said that by developing CDX-110, its oncology business unit “continues to show its commitment to developing the right drug for each patient.”

“We look forward to collaborating with QIAGEN’s DxS unit in the development of this important diagnostic tool that could potentially help physicians better define the most appropriate treatment for patients who suffer from glioblastoma multiforme,” notes Garry Nicholson, president and general manager of Pfizer’s oncology business unit.

Pfizer is the latest global pharmaceutical giant to sign an agreement of this nature with DxS, following similar deals with companies including AstraZeneca and Amgen.
Founded in 2001, DsX is making a name for itself in the field of personalized medicine and has a healthy pipeline of deals, says co-founder Dr. Steve Little, who is also vice president of personalized healthcare for QIAGEN. DxS is also looking to develop kits for use on heart patients as well as those suffering from cancer, he adds.

“QIAGEN is aligned to deliver companion diagnostics to our pharmaceutical partners, and this deal is further evidence of our commitment to develop our scientific and operational capabilities to help select the right patient for the right medicine,” Little says.

Financial terms of the diagnostic agreement were not disclosed.

[tcmgpt13]

Post 1 and post 18 are exactly the same article posted by the same poster. So is this where one says ni, ni, ni? (nee, nee, nee)

YouTube - Monty Python- Knights Of The Round...

[Enviro Girl]

Bayer starts clinical Phase I study with personalized vaccine from tobacco plants

Bayer starts clinical Phase I study with personalized vaccine from tobacco plants
Bayer HealthCare
January 28, 2010

Idiotype vaccination in the treatment of non-Hodgkin's lymphoma

Leverkusen, January 28, 2010 - The transfer into clinical development of a patient-specific vaccine represents a milestone for Bayer Innovation GmbH. Following approval of the Phase I study by the FDA (Food & Drug Administration) in the United States, the vaccine is now being tested in human subjects. This is the first time that proteins obtained from tobacco plants using magnICON® technology undergo clinical testing. The patient-specific vaccines produced in the pilot plant operated by the Bayer-subsidiary Icon Genetics in Halle, Germany, are intended for the treatment of non-Hodgkin's lymphoma (NHL), a type of cancer affecting lymphocytes. The objective of the therapy is to activate the patient's immune system, enabling the malignant cells to be targeted and destroyed by the body's own defense system.

"This personalized vaccine is being developed with the aim of keeping patients who have responded well to chemotherapy in complete remission," explains Dr. Detlef Wollweber, head of Bayer Innovation GmbH. "In other words, it should prevent a recurrence of the tumor. The initiation of this clinical trial also demonstrates that our magnICON® technology is suitable for manufacturing proteins for potential pharmaceutical applications."

The magnICON® technology is a new process for the rapid production of high yields of recombinant proteins such as biopharmaceuticals in tobacco plants. The plant is not genetically modified: The blueprint for the required product is inserted temporarily into the plant using a species of Agrobacterium and distributed throughout the plant cells. The protein is subsequently be extracted from the plant's leaves in a very pure form. The process can also be carried out in a large-scale closed facility.

"The goal of cancer therapy in the future will be to tailor treatment to the individual patient as far as possible," says John Butler-Ransohoff, Project Manager for Plant-made Pharmaceuticals at Bayer. "Hematological tumors such as B-cell lymphomas are a good starting point for the further development of personalized medicine because the idiotypic antibodies formed by the lymphomas are highly specific tumor markers."

Scientists have been trying to trigger an immune response to this type of patient-specific idiotypic antibody (surface immunoglobulins) since the 1990s in the hope of substantially delaying the recurrence of the tumor. In 2006 a team of researchers working with Professor Maurizio Bendandi at the University of Navarra (Spain), succeeded in this objective in a groundbreaking research study involving patients who had previously achieved complete remission with chemotherapy. Bayer's new Phase I study is carried out in close cooperation with Bendandi.

The focus of the currently started first clinical study in volunteers who have NHL is on the safety, tolerability and - to the extent that this can be determined from laboratory tests - immunological effects of the vaccine. In this study, 20 patients will each be given six subcutaneous injections of the personalized vaccine over a six-month period. The humoral and cellular immune responses in these patients will subsequently be characterized in Bendandi's laboratory at the University of Navarra. If the results of this study are sufficiently positive and promising, an application will be made to carry out a Phase III study for registration purposes. The Phase I clinical study which has just started is being performed at the renowned University of Texas Southwestern Medical Center in Dallas (United States). The study is being coordinated locally by DAVA Oncology.

About idiotype vaccination

Idiotype vaccination is a new type of therapy which has not yet been given regulatory approval. It is referred to as active immunotherapy and, unlike most other biological therapies, is specific to the individual patient. This means that each patient is treated with a product tailored to his or her specific needs. The vaccine consists of an antibody - an immunoglobulin - which is present only on the diseased lymphocytes and not on healthy lymphocytes or other cells in the body. This protein is known as an "idiotype." The intention is to produce an individual drug product for each patient and administer it as a vaccine. The objective of the new therapy is to activate the patient's immune system, enabling the malignant cells to be targeted and destroyed by the body's own defense system.

About non-Hodgkin's lymphoma

Non-Hodgkin's lymphoma is a type of malignant disease that occurs within the lymphatic system, and it is the fifth most common cause of death due to cancer after breast, prostate, lung, and colon cancer. It originates from lymphocytes, a type of white blood cells. There are two main types of lymphocytes: B lymphocytes and T lymphocytes (also called B-cells and T-cells). Non-Hodgkin's lymphoma can be divided into two general clinical categories: indolent lymphomas, the most common forms of which include follicular lymphomas which tend to grow relatively slowly; and aggressive lymphomas, which include diffuse large B-cell lymphomas (DLBCL), which grow more rapidly. The overall prevalence of NHL in the European Union is approximately 230,000, with an annual incidence of about 70,000 new cases. Follicular lymphoma is one of the most common types of indolent NHL, accounting for 25-30 percent of all NHL lymphomas. It is a type of cancer which is long-lasting and difficult to treat.

About Bayer Innovation GmbH

Bayer Innovation GmbH (BIG), a wholly owned subsidiary of Bayer AG, evaluates and develops new fields of business for the Bayer Group that are related to Bayer's core competencies of health care, nutrition and innovative materials and complement its current key areas of innovation and business.

About DAVA Oncology, LP

DAVA Oncology is a Dallas (Texas, USA) based oncology drug developments company focusing on accelerating clinical trials. Its team of four full time medical oncologists allows DAVA Oncology to conduct highly complex, elaborate trials in oncology patients using a fixed cost model. DAVA also provides strategic consulting services as well as clinical development planning services to both biotechnology and pharmaceutical companies. For more information, please go to Dava Onocology - About Us

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. The company's products and services are designed to benefit people and improve their quality of life. At the same time Bayer creates value through innovation, growth and high earning power. The Group is committed to the principles of sustainable development and to its role as a socially and ethically responsible corporate citizen. Economy, ecology and social responsibility are corporate policy objectives of equal rank. In fiscal 2008, Bayer employed 108,600 people and had sales of EUR 32.9 billion. Capital expenditures amounted to EUR 2.0 billion, R&D expenses to EUR 2.7 billion. For more information, go to Bayer - Homepage.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at Bayer - Homepage. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.