Columbia company developing kit to help doctors treat breast cancer

Friday, March 3, 2006

Columbia biotech A&G Pharmaceutical is working to create a breast cancer testing kit to help determine patient treatment options.

Officials at the venture-backed company anticipate its biopsy staining kit will soon be one of the diagnostic tools used on a biopsied breast tumor. The kit will test for the presence of GP88, a cancer growth factor present in about 80 percent of breast cancer patients, according to the company.

If a patient tests positive for GP88, doctors will be able to make better decisions about treatment, explained Michael Keefe, vice president of business development.

The finding may be particularly important because breast cancer patients with GP88 may respond poorly to anti-estrogen therapy such as tamoxifen, a commonly prescribed drug that blocks estrogen receptors on breast cancer cells, slowing cancer growth.

The kit is in clinical trials and the company is aiming for Food and Drug Administration approval by the end of 2006, Keefe said.

A&G is also looking at a number of other uses for GP88 testing, including diagnosing the disease and monitoring its presence in those already who have it.

For example, detecting GP88 in the bloodstream of patients in remission could signal the cancer’s return earlier than other tests, providing the patient with more time to fight the disease and a better chance for survival.

‘‘When it comes back, their chance for survival decreases,” Keefe said. ‘‘This could detect recurrence earlier.”

A&G Pharmaceutical Founded: 2000 President: Ginnette Serrero Employees: 14

Keefe likened the GP88’s screening possibilities to that of the prostate-specific antigen test, a protein whose raised levels could indicate the presence of prostate cancer in men.

‘‘It’s too early to tell if it’s going to be a screening test, but it is in the realm of possibility,” he said.

A&G, with 14 employees, was established in 2000. CEO Ginette Serrero discovered GP88 while working as a professor at the University of Maryland, after which she resigned and started the company.

‘‘For me it was my lifelong dream to develop products. Five years later my company is blossoming,” said Serrero, who last month won the Greater Baltimore Region Bioscience Entrepreneurial Spirit Award from the Greater Baltimore Committee .

‘‘She’s extremely driven to see this go from the bench to the market,” Keefe said.

‘‘We all have a common goal — we want this company to succeed,” said Wes Kim, staff scientist at A&G. Kim worked with Serrero at her university laboratory before moving with her to A&G, along with several other researchers.

To pay some of the substantial bills that come with clinical research, A&G runs a ‘‘precision antibody service” designed to assist clients in the first stage of drug discovery. A client, such as university or company, provides the antigen, a foreign substance such as bacteria or pollen, and A&G will create a single corresponding antibody, or immune response, in about 30 days.

Revenues from the service help pay basic operating costs, Keefe said. Additional venture capital has been raised for the expensive clinical trials and drug development.

In October, the company announced it had raised $2 million to help with the cost of clinical trials, including funds from the Maryland Department of Business and Economic Development’s Maryland Venture Fund.

In addition, A&G received two grants from the University of Maryland’s Maryland Industrial Partnerships program. One grant assisted with the clinical trials for GP88, and the other deals with a new possible product for rheumatoid arthritis.

The money is for a University of Maryland, Baltimore, researcher to examine three molecular compounds involved with rheumatoid arthritis for A&G, providing a way to look ahead to other products.

‘‘It affects 2 million people in the United States and is very debilitating ... It doesn’t kill you — it just makes your life incredibly miserable,” Keefe said of the autoimmune disease.

A&G is also looking forward to developing treatment for other diseases.

‘‘We are a bunch of resourceful people,” Serrero said of her staff. ‘‘We can be very inventive.”