|Medarex's "Holy Grail" Against Prostate Cancer|
|Monday, 22 June 2009 23:41|
Prostate cancer is diagnosed in 192,000 U.S. men each year and 27,000 die.
So it's no surprise that even on a terrible down day, like the market experienced on Monday, shares of Medarex inc.(NASDAQ:MEDX) gained nearly $1 as they traded up to $8.28 +0.92 (12.50%) on news of a new hope against this terrible killer. The headlines tell us that two men with inoperable prostate cancer made dramatic recoveries after being given a single dose of the company's experimental drug, Ipilimumab, also known as MDX-010 or MDX-101.
Dr Eugene Kwon, of the respected Mayo Clinic in Minnesota, said: 'This is one of the Holy Grails of prostate cancer research. We have been looking for this for many years.'
The two patients had late-stage cancer, that had spread beyond the prostate, with one blighted by a tumour the size of a golf ball. Patients in such a condition may only have months to live. The pair were given conventional drugs followed by a single dose of ipilimumab.
So many cancer cells were killed off that the men were able to undergo surgery, and both have gone back to their normal lives according to the report.
"I have never seen anything like this before. I had a hard time finding the cancer," said Dr. Michael Bute, the surgeon who operated on the men.
"At one point the pathologist (who was working during surgery) asked if we had samples from the same patient."
Doctors were startled to see responses that far exceeded their expectations. A third 'inoperable' patient underwent surgery last week and 20 more are showing improvements and are being monitored by the surgeons.
A second trial, using higher doses, is planned, but the researchers cautioned that the results would have to be confirmed in further, large-scale studies.
Ipilimumab is a human monoclonal antibody being developed by Bristol-Myers Squibb and Medarex. It is intended to be used as a drug to activate the immune system. Many other labs and researchers have begun to focus their attention on these monoclonal antibodies as treatments for cancer. That type of research involves monoclonal antibodies that bind only to cancer cell-specific antigens and induce an immunological response against the target cancer cell. Such monoclonal antibodies (mAb) could also be modified for delivery of a toxin, radioisotope, cytokine or other active conjugate; it is also possible to design bispecific antibodies that can bind with their Fab regions both to target antigen and to a conjugate or effector cell.
This latest news, just in time for father's day, was much better than the news about Ipilimumab that was out a year and a half ago. In December of 2007, one of the three studies on the drug failed to meet its primary goal of shrinking tumors in at least 10.0% of the study's 155 patients. At that time, the three studies tested 487 patients with advanced skin cancer. Side effects for ipilimumab were widely reported as well after the medication caused rashes, diarrhea and hepatitis in a number of the patients being tested. Still, the companies pushed forward and as reported in our FDA Decisions and Clinical Trials Calendar, these latest results were somewhat expected following earlier guidance.
This is a company focused on the discovery, development, and potential commercialization of fully human antibody-based therapeutics to treat life- threatening and debilitating diseases, including cancer, inflammation, autoimmune and infectious diseases. They apply their own UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody products for itself and its partners.
Another look at the FDA Calendar shows that Medarex got news last month that the U.S. Food and Drug Administration (FDA) had extended by three months the review timeline for the Biologic License Application (BLA) for STELARA™ (ustekinumab) to provide time for a full review of an amendment to the pending application. The application seeks approval to market STELARA for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Generated using Medarex's UltiMAb(R) technology, STELARA is also a monoclonal antibody with a novel mechanism of action that targets certain cytokines, naturally occurring proteins that are important in the body's regulation of immune responses and that are believed to play a role in immune-mediated inflammatory disorders, including psoriasis.
Don't be surprised to see shares in Medarex continue to rise as the company seems fully committed to building value by developing a very diverse pipeline of antibody products to address many unmet healthcare needs. That's a formula for success in the long term, should they continue to succeed and get good news.
On the other hand... "It is really the headline itself of these dramatic responses irrespective of the patient number that is driving the stock at this point," Merriman Curhan Ford analyst Joseph Pantginis told Reuters. The Mayo Clinic published the report about the study in its online research magazine, Discovery's Edge.
"Certain caution is warranted... It is very different from a publication in a peer review medical journal, which usually goes through critical review by other experts," BMO Capital Markets analyst Jason Zhang said.
Those of you biotech investors who are not yet familiar with our complete database of clinical trials and upcoming FDA decisions can access that information here. The data in that calendar database helps keep our readers and investors ahead of the market with very valuable information that is always progressive and updated on a daily basis.
Here is a look at other movers and shakers from the healthcare sector as they traded on Monday, June 22, 2009: