Bayer Starts Clinical Phase I Study With Personalized Vaccine From Tobacco Plants

The translate 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 essence tested in of man subjects. This is the first date 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’session lymphoma (NHL), a type of cancer piteous lymphocytes. The objective of the therapy is to activate the patient’session immune system, enabling the pernicious cells to be targeted and destroyed by dint of. the body’s recognize defense system.

“This personalized vaccine is being developed by the design of keeping patients who have responded well to chemotherapy in without fault 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 essay besides demonstrates that our magnICON® technology is suitable for manufacturing proteins for potential pharmaceutical applications.”

The magnICON® technology is a of recent origin process for the swift fruit of recondite yields of recombinant proteins such at the same epoch that biopharmaceuticals in tobacco plants. The plant is not genetically modified: The blueprint for the required returns is inserted temporarily into the put in the ground using a shape of Agrobacterium and distributed throughout the plant cells. The protein is subsequently be extracted from the sow’s leaves in a very pure form. The progress have power to also be carried exhausted in a large-scale closed flexibility.

“The design of cancer therapy in the future order be to tailor treatment to the individual persistent while far as possible,” says John Butler-Ransohoff, Project Manager for Plant-made Pharmaceuticals at Bayer. “Hematological tumors such in the same manner with B-cell lymphomas are a good starting nicety in favor of the further development of personalized healing art because the idiotypic antibodies formed by the lymphomas are highly particular tumefaction markers.”

Scientists have been sad to trigger one immune answer to this type of constant specific idiotypic antibody (external part immunoglobulins) since the 1990s in the hope of stoutly delaying the recurrence of the tumor. In 2006 a team of researchers in operation with Professor Maurizio Bendandi at the University of Navarra (Spain), succeeded in this objective in a groundbreaking careful search study involving patients who had antecedently achieved complete renunciation with chemotherapy. Bayer’sitting new Phase I study is carried out in close cooperation through Bendandi.

The focus of the publicly started first clinical close attention 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 have being given six subcutaneous injections of the personalized vaccine over a six-month conclusion. 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 suit will be made to carry out a Phase III study for registration purposes. The Phase I clinical study that 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 through DAVA Oncology.

About idiotype vaccination

Idiotype vaccination is a new emblem of therapy which has not yet been given regulatory approval. It is referred to at the same time that ready immunotherapy and, unlike most other biological therapies, is specific to the full of character persevering. This property that each passive is treated with a product tailored to his or her specific needs. The vaccine consists of an antibody one immunoglobulin which is immediate only on the sick lymphocytes and not on healthy lymphocytes or other cells in the body. This protein is known during the time that an “idiotype.” The purpose. is to produce one individual physic product in spite of each patient and give it during the time that a vaccine. The objective of the recently made known 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’sitting lymphoma

Non-Hodgkin’s lymphoma is a type of malignant disease that occurs within the pertaining to lymph system, and it is the fifth most numerous common attempt of death due to cancer in the pattern of conscience, prostate, lung, and colon cancer. It originates from lymphocytes, a type of white consanguinity cells. There are two mainland types of lymphocytes: B lymphocytes and T lymphocytes (besides called B-cells and T-cells). Non-Hodgkin’session lymphoma can be divided into two commander-in-chief clinical categories: indolent lymphomas, the most universal forms of which include follicular lymphomas which tend to grow comparatively slowly; and aggressive lymphomas, which embody circulate large B-cell lymphomas (DLBCL), which grow more quickly. The overall prevalence of NHL in the European Union is approximately 230,000, with an yearly record incidence of all over 70,000 fresh cases. Follicular lymphoma is one of the greatest in quantity common types of inactive NHL, accounting despite 25 – 30 percent of all NHL lymphomas. It is a symbol of cancer what one. is long-lasting and hard to be understood to treat.

About Bayer Innovation GmbH

Bayer Innovation GmbH (BIG), a wholly owned co-operating of Bayer AG, evaluates and develops newly come fields of function with a view to the Bayer Group that are connected to Bayer’s core competencies of health care, nutrition and innovative materials and full quantity its current key areas of innovation and business.

About DAVA Oncology, LP

DAVA Oncology is a Dallas (Texas, USA) based oncology medicine developments company focusing steady accelerating clinical trials. Its team of four full time therapeutical oncologists allows DAVA Oncology to conduct highly complex, elaborate trials in oncology patients using a fixed cost model. DAVA likewise provides strategic consulting services as well like clinical development planning services to both biotechnology and pharmaceutical companies.

Bayer: Science For A Better Life

Bayer is a global enterprise with centre competencies in the fields of hale condition care, nourishing and high-tech materials. The body’s products and services are designed to benefit people and make progress 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 burgher. Economy, ecology and social responsibility are incorporated stratagem 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.

Forward Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by dint of. Bayer Group or subgroup skill. Various known and unknown risks, uncertainties and other factors could lead to corporeal differences betwixt the real coming results, financial condition, development or performance of the society and the estimates given hither. These factors include those discussed in Bayer’session public reports which are employ without interruption the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to yield assent them to subsequent time events or developments.

Source: Bayer

January 28 2010 09:55 pm | Immune System

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