Unwelcome surprise for Vertex as FDA slaps hold on phase 1/2 diabetes cell therapy study was reported by Annalee Armstrong for FierceBiotech.com, 2 May 2022.
Vertex’s new diabetes cell therapy early study of VX-880 was placed on clinical hold after the FDA determined that there wasn’t enough evidence to support increasing the treatment dose as planned.
Vertex reported data on the cell therapy from a single patient in October, which revealed that the patient achieved a “robust” restoration of islet cell function after receiving VX-880. Restoration of these cells could allow patients to regulate insulin or even produce it on their own, rather than use daily insulin treatment or seek an islet cell transplant.
On Monday, Vertex showcased results from one more patient, saying the data continued to add to the proof-of-concept for VX-880. Both of these initial patients received half of the target dose for the study. The company also said that the first patient’s response has proven durable at day 270.
Carmen Bozic, M.D., Vertex’s executive vice president for global medicines development and medical affairs and chief medical officer, said the company was surprised by the clinical hold given the evidence so far supported that VX-880 spurred restoration of glucose-regulated insulin production and improved glycemic control. So far, there have been no serious adverse events deemed related to VX-880, and the majority of reported adverse events were mild or moderate. “The totality of the safety and efficacy data for all three patients dosed to date gives us high confidence in our benefit-risk assessment of VX-880 and its potentially transformative profile,” Bozic said in a statement.
Read more: FDA slaps hold on phase 1/2 diabetes cell therapy study
Extended-wear insulin infusion set lasts 7 days for most wearers was written by Michael Monostra for Healio.com/endocrinology, 5 May 2022.
A novel extended-wear insulin infusion set was usable for up to 7 days for most adults with type 1 diabetes, with no change in glycemic control and few adverse events, according to findings published in Diabetes Technology & Therapeutics.
In findings from a single-arm nonrandomized trial, adults with type 1 diabetes used an extended-wear insulin infusion set from Medtronic along with their own MiniMed 670G system and insulin lispro or insulin aspart for up to 7 days. The overall survival rate at 7 days was 77.8%, with most participants preferring the extended-wear set to standard insulin infusion sets worn before the trial.
“Since 2017, Medtronic began designing a new insulin infusion set with a longer-wear duration and improved performance based on observations that insulin degradation and preservative loss increased the inflammatory response and insulin-associated inflammation contributed to standard insulin infusion set failure,” Bruce A. Buckingham, MD, active professor emeritus at the Stanford University School of Medicine Center for Academic Medicine, and colleagues wrote. “Iterative advancements relative to earlier insulin infusion set devices designed for 2 to 3 days of wear included a new H-cap connector and tubing with new fluid path design that improve insulin preservative retention and stability, in addition to a new extended-wear adhesive patch that improves skin adherence.
Read more: Extended-wear insulin infusion set lasts 7 days for most wearers
Is there money in being an executive at Dexcom? This might take your breath away!
The estimated Net Worth of Steven Robert Pacelli is at least $61.8 Million dollars as of 25 April 2022. Mr. Pacelli owns over 250 units of Dexcom stock worth over $14,383,613 and over the last 16 years, he sold DXCM stock worth over $44,430,596. In addition, he makes $3,020,340 as Executive Vice President – Strategy and Corporate Development at Dexcom Inc.
But wait, there’s more!
Go to the link below for interactive charts! Maybe that’s why Dexcom’s brand color is GREEN!?!?!?
Read more: Steven Pacelli Net Worth
Holy Hell on Dexcom !! WOW. My 10 shares of Dexcom seem pitiful. LOL
So on vertex, I had a telephone appointment today to discuss if I might be a candidate for their phase 2 study. I realized I would not qualify but I was happy to be signed up for the pre-enrollment interview.
I sent all my items, I received a note telling me what to send, etc., and then nothing. I was ready and at 2 PM edt. I held my telephone in my hand ready to answer. Heck, no call. No cancel, no nadda.
Now I read about the ruling last week and so I was not surprised. But heck a listen we won’t call note might have been appreciated? Just saying.
Railroads are often not run out of business as much by competition as by neglect. JUst saying.