Celcuity's triple cancer drug combo tops AstraZeneca's in cutting progression in study
The drug, gedatolisib, in combination with Pfizer's (PFE.N), opens new tab Ibrance and AstraZeneca's (AZN.L), opens new tab endocrine therapy Faslodex, reduced the risk of disease progression or death by 76%, compared to Faslodex alone in previously treated HR+/HER2- advanced breast cancer patients in a late-stage study.
HR+/HER2- breast cancer accounts for about 70% of all breast cancers.
The combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex.
Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' (NOVN.S), opens new tab Afinitor and AstraZeneca's Truqap.
The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, Celcuity said, without offering further details.
The study also showed that a double combination of gedatolisib and Ibrance reduced the risk of disease progression or death by 67%, compared to Faslodex. This combination increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex.
Celcuity plans to report full results from this late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year.
It expects to apply for U.S. marketing approval in the fourth quarter.
Shares of the Minnesota-based firm jumped nearly 114% to $29.4 before the bell.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Reuters
28 minutes ago
- Reuters
Apple says it is partnering with Samsung for new chip technology from Texas plant
Aug 6 (Reuters) - Apple (AAPL.O), opens new tab said on Wednesday it is working with Samsung Electronics ( opens new tab at the latter's chip production plant in Texas to "to launch an innovative new technology for making chips." Apple said the technology "has never been used before anywhere in the world," and Samsung's Texas chip plant "will supply chips that optimize power and performance of Apple products, including iPhone devices," without elaborating further. A Samsung spokesperson declined comment. The statement was made as part of Apple's announcement it would spend an additional $100 billion in U.S. investments, bringing its total investment commitment to the country to $600 billion over the next four years.
The Independent
29 minutes ago
- The Independent
Family issues warning as son dies after taking highly addictive over-the-counter supplement: ‘The government doesn't step in'
A family in Washington is warning about the dangers of kratom — a supplement that can be bought in some gas stations — after they say their son died from using the substance. On the day Jordan McKibban, 37, died in 2022, he reportedly mixed kratom with his lemonade, according to his mother, Pam Mauldin, who spoke to the New York Post. Kratom is marketed as an "all-natural" supplement that can help reduce pain, anxiety, and depression, among other ailments. For some individuals who are wary of typical pharmaceutical medicines — as McKibban reportedly was — kratom can be an attractive alternative. Mauldin found her son unconscious in his room after he drank the kratom-lemonade mixture. She attempted CPR, but could not revive him. 'I've lost my son. I've lost my grandchildren that I could have had, I've lost watching him walk down that aisle, watching him have a life that I get to watch with my other kids. I've lost enjoying these years with him,' she told the New York Post. After his death, an autopsy found that McKibban death was caused by mitragynine, which is found in ktraom. Kratom is made from a Southeast Asian plant and can act as a stimulant when taken in lower doses and a sedative when taken at higher doses. The substance can be bought from online retailers and in stores legally. The U.S. Food and Drug Administration notes that kratom hasn't been shown to be safe or effective at treating any medical conditions. The agency has described it as a "drug of concern." Despite its open availability, national poison control centers have documented 1,807 calls about kratom exposure between 2011 and 2017, and the calls are becoming more frequent, according to Dr Michael Greco, who spoke to the New York Post. He warned that kratom use can, in some people, cause them to experience agitation and "sometimes even psychosis." However, kratom deaths are rare. In McKibban's situation, he was told that he could not overdose on the substance, and that he would simply vomit if he took too much, according to his mother. She noted that her son's kratom bags had no instructions on them or dosage suggestions. 'There have been hundreds of people killed from this, and they don't pull it. The government doesn't step in,' she said. That may be changing. U.S. Secretary of Health and Human Services Robert F Kennedy Jr announced in late July that he plans to crack down on kratom. 'I became an addict because [heroin] was so available, but I had to go to the South Bronx or the Lower East Side. But now you can go to any gas station,' Kennedy told reporters on July 29 while discussing the substance. 'They're marketing them to children: They're gummy bears, they're bright colors, they're candy-flavored. This is really a sinister, sinister industry.' He was referring to a reportedly more addictive and possibly more dangerous offshoot of kratom called 7-hydroxymitragynine. Dr Robert Levy, an addiction and family doctor, told the New York Post that the substance can have similar effects to opioids. 'There's always been concern around kratom because if you take enough of it, kratom does act like an opioid, and people can become addicted to it and have withdrawal from it and overdose on it and ruin their lives on it, like anybody else that has a substance use disorder,' Levy said. He said the offshoot product that is "much more addicting and much more problematic" has infiltrated the market, and many consumers don't know the difference. The FDA recently recommended 7-hydroxymitragynine be classified as an illicit substance. '7-OH is an opioid that can be more potent than morphine,' FDA Commissioner Marty Makary, said in a press release. 'We need regulation and public education to prevent another wave of the opioid epidemic.' Levy recommended that parents talk to their children or loved ones about the substance and remind them that just because something is "all-natural" and plant-derived does not mean it's safe for consumption. "Arsenic is also from a plant," he noted. He advised that anyone with a family member struggling with substance abuse of any kind to seek out available resources and treatment options.
The Independent
29 minutes ago
- The Independent
What is glioma? Symptoms explained after death of young actress
Actor Kelley Mack has died at the age of 33 after being diagnosed with glioma of the central nervous system, a type of brain cancer. Her family announced the news, having previously set up a CaringBridge page to provide updates on her condition. Mack was known for her role as Addy in five episodes of The Walking Dead in 2019, and also appeared in 9-1-1, Chicago Med, and Spider-Man: Into the Spider-Verse. Glioma is the most common type of brain cancer in children and younger adults, originating in glial cells and categorized by cell type, growth potential, and aggressiveness. Symptoms can include headaches, vision problems, and seizures, with treatment options varying from surgery to chemotherapy and radiotherapy, depending on the tumour's grade and location.
