ROCKVILLE, Md., May 16, 2017 /PRNewswire/ -- This month, a new FDA commissioner was confirmed, a promising cancer drug delivered surprising clinical trial results, and China moved ahead of Western nations in human gene-editing experiments. Meanwhile, LabCorp completed a major acquisition and test menus expanded for two infectious disease molecular diagnostics platforms, according to Kalorama Information. The healthcare market research publisher published its most recent report, Virtual Reality and Augmented Reality (VR/AR) Market in Healthcare (U.S. Markets for Surgery; Medical Education and Training; Pain Management, Rehabilitation and Therapy) this week.
Among the top news stories in May are the following:
China moves ahead with human gene-editing trials
Scientists in China are pressing ahead with human gene-editing clinical trials this month. A new human trial began April 28, the Wall Street Journal reported, when an advanced cancer patient was injected with cells that had been genetically modified using Crispr-Cas9 technology.
A different research group in China made history Oct. 28 when it injected the first human with edited cells, part of a small safety trial. The new trial aims to enroll 20 advanced cancer patients, the Wall Street Journal reported, and at least five other human trials are planned.
While China is the first country to use Crispr-Cas9 to treat human patients, the United States is not far behind. A team at the University of Pennsylvania last year got the first approval in the U.S. to test Crispr-Cas9 in humans. That trial is scheduled to start this summer.
Gene editing has been used in humans before, but these are the first trials involving Crispr-cas9, a technology that is simpler and more precise.
The Chinese scientists are using gene editing to encourage a patient's immune system to attack cancer. In the trials underway so far, they collected immune cells and used Crispr-cas9 to disable a gene for a protein called PD-1, which is a "checkpoint" that prevents them from attacking. These immune cells, with their checkpoint disabled, were multiplied and reinjected into the patient in high numbers, in hopes they would kill cancer cells.
The principle is similar that of immunotherapy cancer drugs, including TECENTRIQ and OPDIVO. The drugs are monoclonal antibodies that inactive checkpoint proteins by binding to them, while gene editing inactivates these proteins by removing the genes that code for them.
Promising cancer drug stumbles in trial
TECENTRIQ, an immunotherapy cancer drug on its way to blockbuster status, failed to meet its primary endpoint in a phase III trial, Roche announced May 10.
The drug, also known as atezolizumab, failed to improve survival compared to chemotherapy when used as a second-line treatment for advanced bladder cancer. One factor, Roche noted in a statement, may have been that patients in the comparison chemotherapy arm survived longer than expected.
Roche's stock fell about 2 percent on news of the trial results, Reuters reported.
The drug had received accelerated FDA approval based on promising phase II trial results and was heavily marketed, with sales of more than $112 million in the first quarter, Reuters reported.
Analysts said the drug is now at risk of losing its FDA approval as a second-line treatment for advanced bladder cancer, though it has been approved for other uses.
However Roche is not giving up on the drug.
"While these results are not what we had expected, we believe that TECENTRIQ will continue to play an important role in the treatment of people with advanced bladder cancer," said Sandra Horning, M.D., chief medical officer and Head of Global Product Development in a statement.
TECENTRIQ is involved in more than 30 trials across a variety of cancers, alone and in combination with other therapies, Roche said.
Bristol-Myers Squibb suffered a similar shock last August when the immunotherapy drug OPDIVO unexpectedly failed to improve survival in a phase III lung cancer trial.
LabCorp wraps up latest acquisition
LabCorp announced this month it has completed its acquisition of Pathology Associates Medical Laboratories, a reference laboratory and a healthcare solutions company based in Spokane, Washington.
The deal, which was announced in February, is the latest in the race for expansion between LabCorp and its rival Quest Diagnostics.
LabCorp has acquired mostly its competitors and specialty labs while Quest has focused on health system outreach laboratories, according to a report in Modern Healthcare, so LabCorp's acquisition of PAML, an outreach laboratory operation formerly owned by Providence Health & Services and Catholic Health Initiatives, is a departure.
"This acquisition strengthens LabCorp's relationships with anchor health systems and expands LabCorp's geographic presence in important existing markets, allowing LabCorp to support each health system and its existing customers with expanded offerings," David P. King, chairman and chief executive officer of LabCorp, said in a statement.
Two infectious disease MDx assays get FDA nod
The FDA has cleared a new assay for Luminex Corporation's ARIES molecular diagnostic system, the company announced this month.
The assay uses real-time PCR to detect Bordetella pertussis and Bordetella parapertussis, bacteria that cause whooping cough, in nasal swabs of people who have respiratory symptoms. It is the fourth FDA-cleared assay for the ARIES system in less than two years, the company reports. Luminex plans to submit a Clostridium difficile assay for FDA approval this month, and is completing a clinical trial of its Group A Streptococcus assay for the ARIES system.
The FDA also cleared a C. difficile assay this month for Quidel's Solana molecular diagnostics platform. This is the sixth FDA-cleared assay for Solana.
Molecular diagnostics tests for infectious disease exceeded 3.8 billion dollars in 2016, according to Kalorama Information's new Infectious Disease Molecular Diagnostics Market report. Companies are in tight competition to expand the menus on their integrated analyzers because market share and client retention depend on the ability of one platform to perform all routine infectious disease tests.
Senate confirms new FDA commissioner
Scott Gottlieb, a 44-year-old investor and pharmaceutical company advisor, won Senate confirmation May 9 to be the new commissioner of the Food and Drug Administration.
The biopharmaceutical industry is generally pleased with his confirmation, FierceBiotech reported. Organizations such as the Biotechnology Innovation Organization and California Life Sciences Association quickly released statements applauding the confirmation.
Gottlieb, who served as deputy FDA commissioner under George W. Bush, has advocated for faster drug approvals, less regulation of off-label marketing, and free-market strategies to bring drug costs down, according to the Wall Street Journal.
He is a physician, trained at Mount Sinai School of Medicine in internal medicine, and also a former cancer patient, having survived Hodgkin lymphoma.
Some Democrats opposed Gottlieb's confirmation, citing his strong industry ties.
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