DelMar's Glioblastoma Innovations Receive FDA Fast Track
December 27, 2017 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On December 26, DelMar Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing innovative cancer therapies, announced that the US FDA has awarded the company's main candidate drug VAL-083 for the treatment of recurrent glioblastoma (rGBM) fast track. Confirmed.
Saiid Zarrabian, InterMar's interim CEO, said: "The VAL-083 was granted a fast-track status for rGBM treatment as a milestone and affirmation of the drug's potential for the treatment of cancer patients with or without treatment options. Very pleased with the FDA. On this decision, we will also conduct VAL-083 for other types of cancer treatment research to cope with more clinical unmet needs.
The award for this fast-track status is based on two clinical trials evaluated by DelMar for the evaluation of VAL-083 for the treatment of patients with rGBM, which are:
In collaboration with the University of Texas Anderson Cancer Center, a phase 2 clinical trial in patients who have not received bevacizumab to treat MGMT gene unmethylated GBM; and in the treatment of temozolomide and bevacizumab A clinical phase 3 study (STAR-3) was performed in patients with progression.
The grant of a fast track also means that the drug may be expedited for approval, given a priority review, or may be submitted for rolling NDA files. By granting a fast-track status, FDA seeks a quick resolution of the problems that arise during the development of a drug, often resulting in faster drug approval for patient clinical care.
In addition to the rGBM indication, DelMar has begun VAL-083 for a clinical phase 2 project for the treatment of newly diagnosed MGMT gene unmethylated GBM patients. DelMar also recently received an approval notice from the FDA regarding val-083 clinical trials for the treatment of patients with recurrent platinum-resistant ovarian cancer.
Zarrabian said: "Our ongoing VAL-083 clinical development project has been supported by extensive preclinical studies of the unique mechanism of action of the formulation and positive data from clinical trials conducted by DelMar and the National Cancer Institute. For VAL-083 may be rGBM patients There is significant confidence in bringing meaningful clinical benefits and the opportunity to accelerate the regulatory process through the FDA Fast Track program."
VAL-083, a first-in-class small molecule chemotherapeutic drug with a novel mechanism of action targeting DNA, causes DNA double-strand breaks by DNA cross-linking at the N7 position of guanine. And cancer cells die. In vitro studies have shown that the anticancer activity of this drug is not affected by the common chemotherapeutic resistance mechanisms. (Sina Pharmaceutical Compilation / David)
Article Reference Source: DelMar Pharmaceuticals Announces Fast Track Designation for VAL-083 in Recurrent Glioblastoma
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