In a new development, Germany has allowed the sale of an experimental brain cancer drug from Biotherapeutics Inc. The United States biotech company has received a special exemption which allows it to sell the drug for 5 years despite the fact it has not finished clinical trials.
Biotherapeutics also has the ability to apply for a 5 year extension at the end of the trial period. The shares for the biotech company have risen sharply on the stock exchange in response to the news.
The company had been touting the results of it’s cancer drug “DCVax-L” in a number of patients in clinical trials. The drug will be made available in Germany in out patient clinics and hospitals for any patient with cancer that began in the brain. That is despite the fact that the drug has only been tested on people with the sever Glioblastoma multiforme (GBM) form of the disease.
This is the first time that Germany has allowed a drug to be released in this fashion, so presumably academics have seen some very good outcomes from it’s use. This step by Germany may also lead to other countries in the European Union making promising cancer drugs available quickly, including DCVax-L.
The European Union looks favorably upon quick release of new drugs which have not yet won marketing approval, as a way to encourage biotech companies to set up there.
In early tests, patients taking DCVax-L lived 2.5 times as long as most patients undertaking standard treatment. Standard treatment for brain tumors includes surgery, Temodar chemotherapy and radiation.
Late stage trial data for DCVax-L had been delayed which was a cause of some concern for investors, but this news from Germany has made them very happy. In Germany there are more than 3000 cases of the aggressive Glioblastoma multiforme tumors each year and around 4000 lower grade tumors that might benefit from the new drug.
The company are ramping up for full production of the drug, which should be on sale within a few months in Germany.
The new drug could be a massive windfall with over a billion worth of sales potential in the EU and the United States if it is given full approval. The only thing which might get in the way of cancer patients accessing the drug now is the cost – it will most likely cost more than $70’000 per year for the drug.
However when traditional approaches saw most patients surviving around 14 months, patients on DCVax-L plus the standard treatment survived up to 3 years in the early trials without serious side effects. Analysts warn that the early trials consisted of only a small group of 20 patients.
The drug works by making the body’s immune system track down and kill cancer cells. The immune system’s dendritic cells are controlled and they make antibodies using other cells to agressively kill cancer cells.
A patient’s immature dendritic cells are taken from the blood and mixed with dozens of antigens from brain tumor tissue of the patient obtained in surgery. Then it is purified and injected back into the body as a drug. An exciting new approach to cancer treatment and one of the new forms of drugs that will hopefully improve survival rates in years to come.