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MDx/CDx Focus: Arno Enrolling Patients in Second Onapristone Trial; Genewiz Launches PGxOne


Arno Enrolling Patients in Castration-Resistant Prostate Cancer Trial With Onapristone

Arno Therapeutics announced this week that researchers have enrolled the first patient in a Phase I/II trial evaluating onapristone in men with advanced, castration-resistant prostate cancer following failure on Zytiga (abiraterone) or Xtandi (enzalutamide).

Onapristone, an anti-progestin hormone blocker, is Arno's lead product. The drug has shown activity in Phase II studies against breast cancer. The drug is designed to block activation of the progesterone receptor which breast, endometrial and other tumors depend on to grow and advance. The company recently licensed technology from the University of Minnesota related to a gene signature that will enable it to detect activated progesterone and develop a companion test for gauging best responders to onapristone.

This study is the second Phase I trial involving onapristone to begin enrolling patients this year. In early March, Arno began enrolling patients in a Phase I dose escalation study investigating onapristone in post-menopausal women with progesterone receptor-positive breast, endometrial, and other solid tumors.

Genewiz Launches PGx Panel

Genewiz, a contract research organization providing genomic testing services, this week announced the launch of PGxOne, which helps doctors prescribe the drugs their patients are most likely to benefit from based on the genetic markers they harbor.

The pharmacogenomic panel is designed to run on both the Illumina MiSeq and the Ion Torrent PGM. The test gauges alterations in 25 clinically actionable genes, including markers in CYP, VKORC1, and SLCO1B1.

The Scan

September Plans

The New York Times reports that the US Food and Drug Administration is aiming for early September for full approval of the Pfizer-BioNTech SARS-CoV-2 vaccine.

Nucleic Acids Research Papers on Targeting DNA Damage Response, TSMiner, VarSAn

In Nucleic Acids Research this week: genetic changes affecting DNA damage response inhibitor response, "time-series miner" approach, and more.

Push Toward Approval

The Wall Street Journal reports the US Food and Drug Administration is under pressure to grant full approval to SARS-CoV-2 vaccines.

Deer Exposure

About 40 percent of deer in a handful of US states carry antibodies to SARS-CoV-2, according to Nature News.