When Genzyme Genetics launched its Flt3 mutation-analysis prognostic for acute myeloid leukemia mortality in May, it was also laying the groundwork for the eventual arrival of Flt3-inhibitor drugs that might require such a test to identify responders.
“I think that ultimately that is the goal — to use this as a driver of therapy,” says Celeste Chenet-Monte, marketing director at Genzyme Genetics. But without a complementary drug on the market, the company will only offer the PCR-based test to help physicians better predict mortality in patients with AML. The company’s interest in the test may signal that it believes that demand for a complementary test is significant even in the face of existing competitors in the area such as Quest, LabCorp, and academic centers.
A pharmaceutical company able to develop a promising AML therapeutic has a chance to stand alone in a market with an unmet clinical need. In fact, one company developing a Flt3 inhibitor, Cephalon, has been awarded orphan-drug designation for treatment of AML, according to a Cephalon spokesperson.
According to the American Cancer Society, there will be about 11,930 new cases of AML in the United States this year, and the five-year survival rate of adults younger than 65 is about 33 percent. Currently available AML treatments are associated with treatment-induced mortality rates as high as 25 percent in poor-risk patients, according to the FDA. If Flt3 inhibitors continue to follow the pharmacogenomic route, and responders can be identified using a mutation test, the drugs are likely to be directed against the worst AML cases.
Currently, only Pfizer’s Sutent inhibits the Flt3 receptor tyrosine kinase as part of its effects. But the drug is approved neither for that part of its activity nor for AML. Flt3 is encoded by the gene that Genzyme’s test exploits.
— Chris Womack
AviaraDx, formerly known as Arcturus Bioscience, and Massachusetts General Hospital Cancer Center are teaming up to identify molecular profiles for multiple types of cancer, and hope to develop diagnostics that could help predict the way patients may respond to certain targeted cancer drugs.
Herceptin has been approved by European Union regulators for early-stage Her2-positive breast cancer. According to the drug’s manufacturers, Roche and Genentech, Herceptin was previously approved in the EU only for treatment of advanced Her2-positive breast cancer.
In a trial sponsored by the National Cancer Institute and coordinated by the Eastern Cooperative Oncology Group, researchers will study whether Genomic Health’s Oncotype Dx can be used effectively to assign patients to the most appropriate treatment.
Under the terms of a two-year agreement to research metabolic diseases, Roche plans to provide Entelos with R&D funding and milestone payments for biosimulation research conducted using the Metabolism PhysioLab platform. The approach could be “useful in analyzing existing preclinical and clinical data in order to optimize future clinical trials,” Roche says.
Quest Diagnostics paid $185 million to acquire a portion of Focus Diagnostics, including diagnostics the company has been developing with Stratagene.
US Patent 7,045,605. Modified antibodies to prostate-specific membrane antigen and uses thereof. Inventors: Neil Bander, Francis Carr, and Anita Hamilton. Assignee: Cornell Research Foundation. Issued: May 16, 2006.
Modified antibodies, or related antigen-binding fragments, to the extracellular domain of human prostate specific membrane antigen are provided in this patent. Methods of using the antibodies of the invention to detect human PSMA, or to ablate or kill a PSMA-expressing cell, e.g., a PSMA-expressing cancer or prostatic cell, either in vitro or in vivo, are also provided.
US Patent 7,041,810. Alpha-2 adrenergic receptor polymorphisms. Inventors: Kersten Small and Stephen Liggett. Assignee: University of Cincinnati. Issued: May 9, 2006.
This patent includes polymorphisms in nucleic acids encoding the alpha-2B, alpha-2A, and alpha-2C adrenergic receptor. The invention also pertains to methods and molecules for detecting such polymorphisms. The invention further pertains to the use of such molecules and methods in the diagnosis, prognosis, and treatment of diseases such as cardiovascular and central nervous system illnesses.
Short handle for the Advanced Laboratory Diagnostics Act of 2006, a US House of Representatives bill designed to address reimbursement rates for molecular diagnostic tests.