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MDx/CDx Focus: First Patient Joins Arno's Phase I Onapristone Trial; G2C2 Adds PGx Education Section


Arno Enrolls First Patient in Phase I Dosing Study for Onapristone

Arno Therapeutics announced this week that it has enrolled the first patient in a Phase I dose escalation study investigating onapristone in post-menopausal women with progesterone receptor-positive breast, endometrial and other solid tumors.

Arno is developing onapristone, an anti-progestin hormone blocker, as a treatment for breast and endometrial cancers. Research suggests that onapristone works by hindering the activation of the progesterone receptor (APR), which in turn stops growth of various-types of APR-driven tumors.

Arno is developing onapristone alongside a companion test that picks out which patients are APR positive and will be most likely to respond to the drug. The company recently announced it would work with Leica Biosystems to develop the companion test for onapristone.

In the Phase I study, Arno is hoping to identify the dose that it will give to patients in Phase II safety trial for onapristone in advance endometrioid cancer patients.

The 60-patient Phase I trial being conducted by contract research organization Biotrial at various sites in France and is designed to identify the recommended Phase II dose of onapristone. In the Phase I trial, researchers will study sustained release and immediate release formulations of the drug in up to six doses.

NHGRI's G2C2 Adds PGx Educational Materials

The National Human Genome Research Institute's Genetics/Genomics Competency Center (G2C2) has added educational materials on pharmacogenomics and pharmacogenetics for pharmacists.

The NHGRI launched G2C2 in 2010. The newly added PGx materials were put together by an editorial board of pharmacists wit experience in the discipline. The PGx section includes information on Basic genetic concepts; ethical, legal and social issues; genetics and disease; and PGx implementation.

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