1 Playing It to the Bone
Back surgeons, unlike some of their orthopedic colleagues, can't simply slap a cast over an injury and wait for the bones to heal themselves. Which is why, for decades, scientists have sought a way to stage-manage bone growth. Now doctors at the Hospital for Special Surgery in New York believe they have figured out how to tell the body to grow fresh bone, and to do it much faster than it would on its own, even in delicate areas like the human vertebrae.
Each year, more than 200,000 Americans undergo spinal-fusion surgery as a remedy for chronic back pain. Back pain is usually caused by some sort of instability in the spine, such as a slipped or ruptured disc. Spinal discs act as shock absorbers between the vertebrae. If one ruptures or slips out of place, nerves in the spine get pinched.
In spinal-fusion surgery, the surgeon usually removes the disc altogether and fuses together the two vertebrae that sandwich the troubled disc. Fusion typically requires metal plates and pins, and in order to speed up the process, chips of bone from other parts of the body (or sometimes cadavers) are placed where the surgeon wants new bone to appear. The procedure is very involved and requires a long recuperation period, during which the body creates new bone.
"Something in the body is telling those bones to heal themselves," says Dr. Harvinder Sandhu, who is leading the trials. "And we are at the stage where we've identified the proteins that tell the cells, 'Okay, now it's time to make bone; this is where you're going to make it.' " Dr. Sandhu and his colleagues can now artificially reproduce them and place them where new bone growth is neededusually by dipping a bio-compatible sponge into the liquid protein mix and then placing it where bone is needed. "You're fooling the body into thinking it's had a fracture," he explains.
The result is less-invasive surgery (tiny incisions vs. inches of scar tissue), less spinal trauma, and faster bone regrowth. A patient who would otherwise take six months to fully recover can now be back on his feet in a month or two. And a weeklong hospital stay might turn into same-day surgery. In clinical trials, some patients did, in fact, go home within 24 hours. The trials have been extended to sixteen hospitals throughout the country, and Sandhu hopes to submit results to the FDA soon, which could pave the way for better back surgeries by next year.
2 Combine and Conquer
It's been almost 40 years since the medical community has made serious inroads in the treatment of colon cancer, the second-deadliest cancer in America. But today there are several new drugs that hold great promise, each with strong New York connections. The first, which was approved in 1996, is called CPT-11 and is being incorporated into a groundbreaking treatment regimen for late-stage patients. The other, called C225, was developed by SoHo-based ImClone Systems and, though still in clinical trials, is already showing encouraging results.
Dr. Leonard Saltz of Memorial Sloan-Kettering and his team not only created the new regimen but have taken the lead on the study of the C225 drug as well. (According to Saltz, C225 is currently a "hot molecule" in cancer circles.) In a nutshell, the C225 drug is an antibody that attaches itself to tumor cells, blocking the signals that tell the tumor cell to grow. It also appears to make tumor cells more vulnerable to radiation or chemotherapy, making them easier to destroy. Dr. Saltz is testing the drug's impact on colon cancer, but ImClone is also looking at potential benefits for head, neck, and lung cancers as well.
While studying the specific effects of C225, Saltz is also exploring its efficacy in combination with a variety of "boutique" chemotherapies (a dissonant designation if there ever was one) and multiple-drug cocktails tailored to the unique genetics of each tumor. Each of these studies builds on Saltz's recent successful development of a new chemotherapy treatment for late-stage-colorectal-cancer patients, which involved mixing a traditional cancer-fighting drug known as 5FU with CPT-11. The results, which were published in September, showed almost a doubling of the number of patients whose tumors shrank.
Saltz plans to start testing the therapy on earlier-stage patients; if it's successful, it may not only extend the lives of the critically ill but perhaps increase the percentage of patients who are cured altogether.
C225 should enter phase III clinical trials (the last stage) this summer and be tested at more than 70 hospitals and research centers around the country, with Saltz as the lead investigator. Its effectiveness is being tested in tandem with established cancer-fighting drugs, and on patients who haven't responded to traditional chemotherapy treatment. ImClone plans to file for approval with the FDA in May, and because the drug has been fast-tracked, the review process could take as little as six months.
"It's a very exciting time to be a researcher in colon cancer," says Saltz. "We've started to have higher standards for what we can offer our patients right now. And it's the tip of the iceberg in terms of what we're going to be offering in the very near future."