Tomorrow's Drugs - Pharmaceutical Executive


Tomorrow's Drugs
Seven top therapies and technologies vying to deliver the next decade's breakthroughs and blockbusters. They want to become...

Pharmaceutical Executive

Dan Montano, CEO of CardioVascular BioTherapeutics
He liked the approach as a solution to an oncologist's problem. But he was a cardiologist, and saw the concepts in the article as a potential application to heart disease as well. "What the tumor researchers do not want [the growth of the new blood cells] would be very much desired by our patients who suffer from narrowed, calcified, occluded vessels," he wrote later, describing the "a-ha" moment.

"Stegmann developed this treatment with his own money to prove that he could grow blood vessels—and he did it," says Dan Montano, chief executive officer of CardioVascular BioTherapeutics, the company that is now developing the Stegmann's discovery.

The treatment uses fibroblast growth factor 1 (FGFR1), a protein that the body naturally creates. CardioVascular BioTherapeutics concentrates the protein and delivers FGFR1 directly into the heart, setting off an angiogenic effect.

In Phase I, the treatment was delivered surgically through a small incision in the chest. Going forward, the drug will be administered with a catheter, much like an angioplasty. The treatment consists of one injection per area. A person with, say, four blockages might need four injections, each in a different area. Using the catheter, patients can get the treatment and be out of the hospital in one day. The angiogenesis process takes approximately 12 weeks.

"The majority of the patients had miraculous recoveries," says Dave Balekdjian of the Bruckner Group, which has consulted with CardioVascular BioTherapeutics. "It's one thing to get a treatment and live longer, but it's another to return them to the quality of life they were used to before they became ill."

To date, there have been no known side effects or safety issues, probably due to the fact that the protein is injected in a relatively small quantity and is injected directly into the blockage. According to research, the body clears the protein within six hours.

"Normally, people wouldn't be getting excited about a drug that is just hitting Phase II, but the difference is that the drug has been dosed in more than 70 patients, and there are long-term outcomes data," Balekdjian says. The company can image the growth of new arteries and see the physical evidence of angiogenesis with before-and-after pictures.

CardioVascular BioTherapeutics seems to be in the lead in bringing this treatment to market, but it's not alone. Business Week recently reported that close to 700 angiogenesis-based drugs were in development. Many are for cardiac care, but other areas under consideration include wound healing, eripheral arterial disease, chronic back pain, and stroke. Stegmann also hopes that FGFR1 will lead to medical treatments for neurological diseases such as smyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, and spinal cord injury. –GEORGE KORONEOS


A new technology may revolutionize the generic and biosimilar markets

We're living in the protein decade, and pharma's big recent developments have been so focused on strings of amino acids that it's easy to forget that they're not all there is to life—and disease.

Craig Wheeler, CEO of Momenta
What else is there? How about sugars? All human cells are covered with complex mixes of sugars, which play a major role in controlling biological processes. Even the protein drugs that have transformed the pharma world are mostly, strictly speaking, glycoproteins—combinations of proteins and sugars. Every bit as important as to health as DNA and proteins are, sugars play a major role in the cause and treatment of cancer and infections, as well as cardiovascular, inflammatory, and Alzheimer's diseases.


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