LMPD: Woman dies after car crashes into tree near Cherokee Park LMPD: Woman dies after car crashes into tree near Cherokee Park TIP LINE. A WOMAN IS DEAD AFTER A CAR CRASH ON CHEROKEE PARKWAY. IT HAPPENED AROUND SEVEN: 15 P.M. THIS EVENING ON CHEROKEE ROAD. POLICE SAY THE WOM The latest breaking updates, delivered straight to your email inbox. LMPD: Woman dies after car crashes into tree near Cherokee Park A woman is dead after a crash Friday near Cherokee Park.Louisville Metro police said the crash was reported after 7 p.m. in the 1500 block of Cherokee Road. That's where 5th Division officers were notified of a vehicle crash.When the officers arrived, investigators said they learned the woman was driving on Cherokee Road near the traffic circle when, for reasons unknown, she lost control of the vehicle and struck a tree on the side of the road.According to police, the woman was pronounced dead at the scene.The coroner's office has not identified the woman. She was the only person in the car.Officials said the LMPD's traffic unit is handling the investigation. A woman is dead after a crash Friday near Cherokee Park. Louisville Metro police said the crash was reported after 7 p.m. in the 1500 block of Cherokee Road. That's where 5th Division officers were notified of a vehicle crash. When the officers arrived, investigators said they learned the woman was driving on Cherokee Road near the traffic circle when, for reasons unknown, she lost control of the vehicle and struck a tree on the side of the road. According to police, the woman was pronounced dead at the scene. The coroner's office has not identified the woman. She was the only person in the car. Officials said the LMPD's traffic unit is handling the investigation.https://www.wlky.com/article/lmpd-woman-dies-after-car-crashes-into-tree-near-cherokee-park/36364747
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For a market approval in Japan, the PMDA set a specific requirement for the number of participating Japanese patients of a total of 56 Japanese patients (of which 14 Japanese patients sneak a peek at this web-site. were already included in the primary recruitment of 440 patients) in the AGENT study. The rationale for the specific requirement from PMDA is e.g. that the metabolism of Japanese patients tends to differ from patients in other countries, which is why the effect and potential side effects must be investigated separately. For the rest of the world, the original 440 patients will be analyzed for efficacy, but the full patient population will be analyzed for safety purposes. "I am satisfied that we now have completed the recruitment of the Japanese patients, an important step on the way to receive market approval in Japan, the second largest oncology market worldwide. We are now looking forward to continue working with Solasia on the development and registration of arfolitixorin to bring a new treatment option to patients living with mCRC in Japan", said Ulf Jungnelius, M.D, CEO of Isofol. Solasia Pharma ("Solasia") will fund and supervise clinical development activities in Japan and will be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Isofol remain the global sponsor of the AGENT study. "We are very pleased to have completed the recruitment of the target number of patients in Japan in the AGENT study and contributed to the global development of arfolitixorin. I would like to thank all the patients and investigators participating in the study, the CRO in charge of conducting the study, and Isofol, our partner and the sponsor of the AGENT study, for supporting us achieve this important goal. Patient recruitment was completed earlier than expected, and Solasia, together with Isofol, will further proceed development of arfolitixorin for market approval in Japan with the aim of becoming a new treatment option for mCRC patients", said Yoshihiro Arai, President & CEO of Solasia. Arfolitixorin is evaluated in the AGENT study for the treatment of patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in more than 90 clinics. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on May 6, 2021. The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL).https://www.prnewswire.com/news-releases/isofol-completes-recruitment-of-japanese-patients-in-the-global-phase-iii-agent-study-301285284.html