Cymabay Therapeutics Inc.'s chief scientific officer, Charles McWherter, told BioWorld that the concept of liver enzyme scores as a powerful indicator of efficacy vs. liver fat reductions in nonalcoholic steatohepatitis (NASH) "is not an entirely made-up idea, just because we got this result" in the phase IIb study of peroxisome proliferator-activated receptor (PPAR) delta agonist seladelpar. "If you had to choose between reducing fat, which can be harmful or can be inert, or showing evidence of improving the underlying lesions and injury" as a way of showing a drug's worth in NASH, he said, researchers might choose the latter as "more proximal to the injury," McWherter said. As Newark, Calif.-based Cymabay's chief medical officer, Pol Boudes, put it, "the fat story is not the end of the story" in NASH.
Tilos Therapeutics Inc. CEO Barbara Fox told BioWorld that the relationship with Merck & Co. Inc. "went pretty deep pretty fast," culminating in the pharma giant's decision to take over her firm for as much as $773 million. "We never intended to do this," she said. "We always assumed we were going to raise a series A, take these [candidates] forward independently, get some clinical proof of concept and look for partnerships later."
Xeris Pharmaceuticals Inc. CEO Paul Edick said a fourth-quarter launch of Gvoke (ready-to-use glucagon injection) for severe hypoglycemia is "still doable. Is it now a tad more of a stretch? Yes." His remarks came as investors learned that the PDUFA date for the injector pen has been pushed back by three months, putting the new decision time for the severe hypoglycemia treatment at Sept. 10, 2019.
CHICAGO – Though it's not optimal in some other cancer types (such as pancreatic and cervical), the minimally invasive method of laparoscopic surgery in colorectal cancer (CRC) with liver metastases vs. the more dramatic "open" surgery leads to the same rate of survival. That's according to findings unwrapped at the American Society of Clinical Oncology (ASCO) annual meeting, where attendees heard results from the randomized study called Oslo-Comet determining that patients lived more than 6.5 years after surgery, regardless of whether it was laparoscopic or open.
CHICAGO – On its last full day, the American Society of Clinical Oncology (ASCO) annual meeting continued to feature abstracts related less to drug development than to social issues, as lead study author Marina Stasenko, of the Memorial Sloan Kettering Cancer Center in New York, offered details of a survey that found 64% of gynecological oncologists experienced sexual harassment in training or practice. Among women, the rate was 71% and among men 51%, but only 10% reported their incidents to officials. Women were more likely than men to respond that gender affected career advancement (34% vs. 10%) and played a role in setting their salary (42% vs. 6%).
An appreciative audience at the American Society of Clinical Oncology (ASCO) heard details of two important prostate cancer trials, including an interim analysis of the international randomized, phase III Enzamet study finding that 80% of men with metastatic hormone-sensitive prostate cancer (mHSPC) were alive after three years when given the non-steroidal anti-androgen (NSAA) drug Xtandi (enzalutamide) from New York-based Pfizer Inc. and Astellas Pharma Inc., of Tokyo, along with standard of care therapy. That number compared with 72% of men who received other NSAAs along with the typical treatment.
CHICAGO – A crowded briefing session at the American Society of Clinical Oncology (ASCO) annual meeting heard society expert Harold Burstein declare that the "golden age" of cancer research is continuing with data from the phase III trial called Monaleesa-7 with Kisqali (ribociclib, Novartis AG).
CHICAGO – With three featured abstracts that dealt with studies of socioeconomic disparities in access to medical help, as well as proof of boons conferred by the Affordable Care Act (ACA), panel members at the American Society of Clinical Oncology (ASCO) annual meeting found themselves in uncommonly delicate territory.
