17 Jun BIO 2008: Targeted therapies enjoy banner year
San Diego, Calif. – With all the buzz about stem cell research breakthroughs and other highlights in a year of life-science innovation, it was targeted therapies with companion molecular diagnostics that gained the most in terms of development and usage, according to a new study released by Deloitte Consulting.
The study, whose findings were shared during the 2008 BIO International Convention in San Diego, indicated that four technologies advanced the most: targeted therapies, monoclonal antibodies, radiotherapy, and drug-device combinations.
But it was targeted therapies with companion molecular diagnostics that have experienced the greatest surge, rising 50 percent in just three years, according to Deloitte. Targeted therapies with companion molecular diagnostics quickly have progressed from idea to reality. Not only have new molecular diagnostic products entered the market, but innovation still is active and product development continues.
“As a first step toward more personalized treatments, targeted therapies with companion diagnostics are reaching more patients,” Matthew Hudes, director of the study, said in a statement released with the findings. Hudes is the U.S. managing principal of biotechnology for Deloitte’s Life Sciences and Health Care practice.
Targeted therapy and personalized medicine
That rise of molecular diagnostics bodes well for Madison-based molecular diagnostic companies like Third Wave Technologies, which has been acquired by the Massachusetts firm Hologic, and EraGen Biosciences, which sells molecular diagnostic products to clinical diagnostic laboratories.
Third Wave expects Food and Drug Administration approval next year for its diagnostic tests for the human papilloma virus, or HPV, which has been linked to cervical cancer.
EraGen already has 11 products on the market, most having to do with the detection of viruses that cause infectious diseases.
As CEO of Quintessence Biosciences, Ralph Kauten is an interested observer of the Madison biotechnology scene. He has been outspoken about the promise of various biomedical technologies, particularly stem cell therapy, RNA interference (the calling card of Madison’s Mirus Bio Corp.), and personalized medicine.
Targeted therapies with companion molecular diagnostics, Kauten notes, fit into the concept of personalized medicine. Personalized medicine suggests that medicines do not work universally across all patients, but a specific medicine may be more appropriate for a specific patient.
“The right medicine for the patient is determined through pre-dosage diagnostics (perhaps using genetic analysis along the lines owned by Third Wave) and confirmed through post-dosage diagnostics (measuring patient response),” Kauten wrote in an e-mail.
Another promising area, monoclonal antibodies, or MAbs, have achieved widespread clinical acceptance in the past three years, according to Deloitte. That hard-won progress comes after more than 20 years of variable progress, and while innovation has declined as development has risen, new methods have brought a fresh set of innovations already being used in the clinic.
Madison has some skin in this game, given NeoClone Biotechnology’s emergence as an international player. The company’s MAb products are used by researchers in 30 countries for the detection of disease, one product under development is a test for ovarian cancer.
Drug development for cancer is another one of the more promising areas for MAbs, which serve as targeted therapies, according to Kauten. Unlike chemotherapies, targeted therapies are engineered to have affinity for proteins, which have a tendency to be more prevalent on the surface of cancer cells. As a result, MAbs tend to be more gentle than chemotherapies, which typically work on any rapidly dividing cell, causing hair loss, nausea, and low white blood counts experienced by patients.
(Quintessence Biosciences is developing an anti-cancer treatment, a protein called QBI-139, which does not have the harsh side effects normally associated with chemotherapy.)
Even though targeted therapies are not as harsh as chemotherapies, they are not as broadly effective – in part because they do not work across a broad base of patients. Still, they are becoming more widely used in cancer treatment, Kauten indicated. For example, Avastin (developed by Genentech) was first approved for use against colon cancer, and more recently it has been approved for use in breast cancer.
“In attending cancer meetings, the trend for new products appears to be application of MAbs to additional cancer types, and the development of additional MAbs,” Kauten noted.
The basis of the Deloitte study is to separate the hope from the hype. Given the recent volatility and the pace of scientific discovery, there is a need to distinguish between technologies that are emerging and ones that are losing ground, according to Hudes.
The study concluded that unmet consumer needs present opportunities for pharmaceutical manufacturers, biotechnology firms, and medical device manufacturers, but there are plenty of obstacles. Despite the progress reported in several areas, Hudes said significant economic, reimbursement, and regulatory challenges remain, “and they could prevent valuable treatments from reaching the public.”
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