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Last Updated: Apr 16, 2008 - 5:52:06 PM |
TUESDAY April 8, 2008 (foodconsumer.org) -- Antigenics' Oncophage treatment for kidney cancer patients was approved for use in Russia, according to news media reports.
The drug is intended for patients with medium risk of cancer relapse and the biotechnology company expects to put Oncophage on Russian market in the second half of 2008.
Oncophage is a personalized medicine. It is made from each patient's tumor and contains the antigenic fingerprint of the patient's cancer. The drug is designed to reprogram the immune system to target cancer cells only.
News media says the drug was not approved in any other countries except Russia. The company was said to file for approval in Europe this year.
We compile the following common questions and answers about Oncophage for those who might be interested in knowing this unique drug.
Common questions and answers about Oncophage
What is Oncophage?
Oncophage is a patient-specific vaccine designed to treat cancer with the intent of minimizing side effects. The drug is designed to target only cancerous cells and it may be used to treat a number of cancers including kidney cancer.
How does Oncophage work?
Oncophage contains the particular cancer's fingerprint such as unique antigens that can trigger an immune response. Injection of the drug stimulates the patient's immune system to recognize and attack any cells bearing the specific cancer fingerprint.
How is Oncophage manufactured?
Oncophage is a personalized medicine. The drug is made from individual patients’ tumors. Once a tumor is removed by surgery, part or all of the cancerous tissue is shipped overnight to Antigenics' manufacturing facility in Massachusetts. From the tissue, the heat shock protein gp96 and its associated peptides are isolated. The complexes are extracted, purified, sterilely filtered and packed in vials. After further processing, the vials are shipped frozen back to the hospital pharmacy for use in the patient.
What is the difference between Oncophage and other cancer treatments?
The difference is that Oncophage is a patient-specific vaccine that triggers immune system to attack only cancer cells.
How is the patient treated with Oncophage?
The patient receives Oncophage within four to eight weeks after surgery if the vaccine is successfully prepared from the tumor. The patient receives one injection of Oncophage every week for four weeks, and then he is given one injection every other week.
How many patients have used Oncophage therapy?
So far, more than 750 cancer patients in more than a dozen clinical trials around the world have been treated with Oncophage. Many of the patients had advanced cancer including kidney cancer, melanoma and colon cancer and had poor response to traditional cancer treatments.
What are the side effects of Oncophage?
"The most common side effects reported in clinical studies with Oncophage were injection-site reactions, pain (in extremities, back, chest, abdomen), nausea, constipation, fatigue, fever, diarrhea, edema (organ/tissue swelling due to excess fluids), weight loss, nasopharyngitis (cold symptoms), arthralgia (pain in the joints), dizziness, anxiety, depression, cough, dyspnea (difficulty breathing), headache, vomiting, anemia, insomnia (difficulty sleeping), anorexia (loss of appetite) and asthenia (weakness)," Antigenics states on its website.
What cancers have been treated with Oncophage?
Oncophage has been evaluated in two international Phase 3 trials for treatment of kidney cancer and metastatic melanoma, as well as in studies for treatment of several other cancers, such as non-small cell lung cancer, lymphoma, colorectal cancer, pancreatic cancer and gastric cancer.
In a current trial, Oncophage is being evaluated for treatment of recurrent glioma.
How effective is the treatment with Oncophage?
One Phase 3 trial of Oncophage showed a 44 percent improvement in recurrent-free survival in a well-defined subgroup of earlier stage patients, but a significant improvement was not observed in the overall patient population.
In a Phase 3 study of Oncophage in metastatic melanoma, overall median survival for those who received at least 10 injections of Oncophage was 29 percent longer than those treated by traditional therapies.
The document is compiled based on information provided on Antigenics’ website.
Also read press release by the company.
© 2004-2008 by foodconsumer.org unless otherwise specified
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