Biotech Values

[Bio_pete]

CVBT.ob - I'm still trying to figure out how they got an article in BusinessWeek. Does anyone have a position? They have one Phase I clinical trial.

The Search for Angiogenesis Therapy
The race is on to win FDA approval for a treatment that enables the human body to grow new blood vessels

by Connie Johnson Hambley
Technology

Three years ago, options had run out for Gail Keller, then only 39 years old. The Ohio woman had had triple-bypass surgery six years prior, but the benefits had worn off. "Walking even halfway into a store made me exhausted," she says. "I would have to rest every two or three steps." So she volunteered for an experimental procedure that uses proteins produced by the body to grow new blood vessels. It wasn't long before she was doing for herself what her aging parents had previously done for her. "Now I can care for them," she reports.

The science of enabling the human body to grow new blood vessels is known as angiogenesis and there's a race within the biotech industry to be the first company to win Food & Drug Administration approval for such therapies. More than $4 billion has been invested in research and development of angiogenesis-based medicines, "making this one of the most heavily funded areas of medical research in human history," according to the Angiogenesis Foundation, a Cambridge (Mass.)-based nonprofit organization. All told, more than 300 million people worldwide could benefit.

There are currently 659 clinical trials under way that mention some form of angiogenesis, which could become a primary treatment for diabetes-related complications, peripheral arterial disease, chronic back pain, stroke, wound healing, and even erectile dysfunction.

The biggest push is in the $65 billion cardiac care arena. With many diseases, clogged and damaged arteries cannot carry the volume of blood required for the body to function normally. With coronary artery disease, the heart starves for oxygen, leading to angina and heart attacks. Once drug therapy options are exhausted, state-of-the-art treatment runs to stents, angioplasties, and bypass surgery. Surgeries can be highly invasive and very expensive. And the benefits frequently do not last.

Some surgical procedures are simply ineffective. "The problem is that surgery only treats the narrowings in the large arteries," says Dr. Lynne Wagoner, director of cardiac services at the University of Cincinnati. "Meanwhile, the small vessels continue to be blocked and this is not addressed by surgery or stents." She adds that angiogenic "treatments are targeted towards small-vessel disease, which cannot be treated with surgery or stents because the vessels are too small."

Hence the race for angiogenesis-related therapies. It's a contest that involves players across the health-care spectrum, including Genzyme (GENZ) and Baxter International (BAX) in search of gene-based therapies, and Boston Scientific (BSX) in the area of medical devices.

But with large companies under pressure to bring drugs to market swiftly, some are hanging back as part of the most promising research is handled by smaller biotech players. "The bigger companies are largely out of this field now," says Dr. J. Anthony Ware, vice-president, cardiovascular and acute care, at Eli Lilly (LLY) Research Laboratories.

In the health-care industry, cost is measured not only during creating, testing, and delivering a product or treatment, but in monitoring and maintaining the benefit from that treatment for the life of the patient. More insurance companies are using outcomes-based analysis to look at medical and financial costs to determine a new treatment's eligibility for coverage.

The real winner in the field of angiogenesis will be evaluated by looking at the cost of the outcome for the patient and the industry as a whole.


That opens the field to contenders such as CardioVascular BioTherapeutics (CVBT). The Las Vegas company uses a naturally produced protein called fibroblast growth factor (FGF-1) to grow new blood vessels in the hearts of so-called zero-option patients, those patients who have no other treatment options available and in many cases are given less than two years to live.

CVBT co-founder Dr. Thomas Stegmann knew he was on the right track when, in 2006, he celebrated a 10-year reunion with patients from his first trial in Germany. "I focused on a human protein because of the lack of side effects," Stegmann says. "With a minimally invasive procedure, an injection of a growth factor can be delivered to the area of the blockage where tissue is not receiving enough blood. The patient goes home the next day and gradually feels better as new vessels grow over the next 12 weeks or less."

The focus on protein could give CVBT an advantage. Protein-based therapies "are intuitively right to create a natural bypass" around a clogged artery, says Dr. Joseph Kaufman, chief medical officer of Sierra Health Services (SIE). "From a financial perspective it is potentially cost-effective to eliminate long-range failure of muscle function. As treatments become more successful, people live longer, requiring more treatments and thereby increasing overall costs." According to a study by consultancy the Bruckner Group, use of FGF-1 could save health-care insurers up to 20% of treatment costs for limited-option coronary artery disease patients over a five-year period after treatment.

It's for reasons like this that CVBT may be well ahead of the pack in developing an effective and economic angiogenic therapy—and setting new standards for cardiac care.

http://www.businessweek.com/technology/content/jul2007/tc2007075_259598.htm?chan=search