WASHINGTON – Maryland biotech company A&G Pharmaceutical is working to create a breast cancer testing kit to help determine patient treatment options, while generating profits for the venture capital-backed company.
A&G anticipates 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 for A&G.
The finding may be particularly important because breast cancer patients with GP88 may respond poorly to anti-estrogen therapy like 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 infected.
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 reoccurrence earlier."
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.
The venture-backed Colombia company employs 14 people, and has been in business since 2000. Chief Executive Officer Ginette Serrero discovered GP88 while working as a professor at the University of Maryland. Serrero resigned her position as professor and started the company.
"For me it was my lifelong dream to develop products. Five years later my company is blossoming," she said.
"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 the 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 like bacteria or pollen, and A&G will create a single corresponding antibody, or immune response, in about 30 days.
The money from the service helps pay basic operating costs, Keefe said. Additional venture capital funds are 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 new grant provides A&G a way to look past GP88 to other viable and profitable products. The new grant money is for a University of Maryland, Baltimore, researcher to examine three small molecular compounds involved with rheumatoid arthritis for A&G.
"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 more disease targets.
"We are a bunch of resourceful people," Serrero said of her staff. "We can be very inventive."
The Capital News Service contributed to this report.