Celldex Therapeutics, Inc. (NASDAQ:CLDX) declared it would halt a late-stage study of the organization’s brain cancer vaccine. The reason was an independent analysis indicated that the therapy does not show better results as compared with standard chemotherapy.
Anthony Marucci, Co-founder, President, and CEO of Celldex said that the organization was extremely disappointed for affected patients that the late study failed. He added that this was not definitely the desired outcome. However, they had immense faith in the technology of immunotherapy to radically change the quality of cancer treatment.
The vaccine called Rintega is part of an emerging category of drugs that make the immune system recognize and destroy cancer cells. It is aimed at tumors having a genetic mutation occurring in around one-third of all GBM (Glio Blastoma Multiforme) patients. This makes it around 4,000 cases in America.
Presently GBM has no cure and is the most frequent and devastating type of brain cancer. GBM tumors develop resistance to treatment relatively faster. As per experts, the average survival rate for freshly diagnosed cases is around 14-15 months if conventional chemotherapy is given.
A study determined that the survival rate of freshly diagnosed GBM patients who were treated with Rintega was same as those in the control group. Celldex said it was leaving the study and did not anticipate incurring significant extra cost. Data of 73 patients in a mid-stage trial earlier demonstrated that supplementing standard therapy with the vaccine helped patients having a recurrent type of GMB live for longer.
Celldex then tried to utilize the data to obtain faster approval for the vaccine. However, the U.S. Food and Drug Administration had asked the company to wait until data from the late-stage study arrived prior to filing an application for marketing.
The drug will be offered on a compassionate use basis to affected patients. Celldex is currently conducting seven clinical trials for five potential drugs.
Celldex shares which were worth $30 each in March 2015 and around $15 at the close of last year have decreased substantially prior to the release of the data. On Friday, the closing price was $8.19 per share.