Oncophage (brand name Vitespen), also known as ''cancer vaccine heat shock protein peptide complex-96'' and ''cancer vaccine HSPPC-96'', is a personalized

cancer vaccine A cancer vaccine is a vaccine that either treats existing cancer or prevents development of cancer. Vaccines that treat existing cancer are known as ''therapeutic'' cancer vaccines or tumor antigen vaccines. Some of the vaccines are "autologous", ...

developed by the American biopharmaceutical company Antigenics Inc. (now Agenus) that is evaluated in multiple clinical trials. It has been granted fast track and orphan drug designations from the

US Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

for

kidney cancer Kidney cancer, also known as renal cancer, is a group of cancers that starts in the kidney. Symptoms may include blood in the urine, lump in the abdomen, or back pain. Fever, weight loss, and tiredness may also occur. Complications can include spr ...

, metastatic

melanoma Melanoma, also redundantly known as malignant melanoma, is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. Melanomas typically occur in the skin, but may rarely occur in the mouth, intestines, or eye ( ...

, and

glioma A glioma is a type of tumor that starts in the glial cells of the brain or the spine. Gliomas comprise about 30 percent of all brain tumors and central nervous system tumours, and 80 percent of all malignant brain tumours. Signs and symptoms ...

. The investigational agent is not yet approved in the US but was approved in

Russia Russia (, , ), or the Russian Federation, is a List of transcontinental countries, transcontinental country spanning Eastern Europe and North Asia, Northern Asia. It is the List of countries and dependencies by area, largest country in the ...

in April 2008 for patients who have earlier-stage kidney cancer. The

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

is evaluating conditional approval for Oncophage. Oncophage is one of a group of new drugs called

s that intend to train the body's immune system to fight the cancer. While chemotherapy is often accompanied by severe side effects, cancer vaccines tend to have only minimal ones (often only inflammations of the injection site). In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine. However, after a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on 19 November 2009, Antigenics Inc. decided to withdraw their application for approval by the

shortly after on 23 November 2009.

Description

Oncophage (Vitespen) is a vaccine made from a patient's tumor by extracting

heat shock protein Heat shock proteins (HSP) are a family of proteins produced by cells in response to exposure to stressful conditions. They were first described in relation to heat shock, but are now known to also be expressed during other stresses including expo ...

gp96 Heat shock protein 90kDa beta member 1 (HSP90B1), known also as endoplasmin, gp96, grp94, or ERp99, is a chaperone protein that in humans is encoded by the ''HSP90B1'' gene. HSP90B1 is an HSP90 paralogue that is found in the endoplasmic reticulum. ...

and its associated peptides.

Clinical trials

One trial is evaluating the investigational agent alone in patients with first recurrence of glioma while the second trial is evaluating Oncophage (Vitespen) in combination with

Temozolomide Temozolomide (TMZ), sold under the brand name Temodar among others, is a medication used to treat brain tumors such as glioblastoma and anaplastic astrocytoma. Text was copied from this source which is © European Medicines Agency. Reproduction i ...

, a common chemotherapy, in patients that are newly diagnosed with brain cancer. A first phase I clinical trial in glioma extended median survival of the group of patients, which was diagnosed with multiple recurrencies of glioma, to over 10 months.

References

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External links

New website (the company changed its name and the name of the vaccine

Information on the manufacturer website
Cancer vaccines Orphan drugs Experimental cancer treatments