Moleculin Biotech (MBRX) Granted FDA Fast Track Designation of WP1122 for the Treatment of Glioblastoma Multiforme
- Wall St opens lower ahead of Fed decision; AMD rises on outlook
- Snap shares plunge 14% following Q4 report, warns of sales drop; analysts mostly bearish
- U.S. private payrolls growth slows in January amid severe weather - ADP
- BofA's top indicator projects S&P 500 at 4700 over the next 12 months
- AMD shares rise after Q4 report that beat expectations for revenue, EPS
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation of WP1122 for the treatment of Glioblastoma Multiforme ("GBM"). The FDA's Fast Track designation is intended to potentially facilitate the development and expedite the review of novel therapies to treat serious conditions for which there is unmet medical need. With the Fast Track designation, Moleculin is potentially eligible for more frequent regulatory meetings and communications with the FDA.
"We believe receiving Fast Track designation validates the serious unmet medical need for the treatment of GBM, the most aggressive form of malignant primary brain cancer," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "We believe that based on the promising animal model data that supports GBM as one of many potential indications, the clearance of our IND for WP1122 in GBM, and Orphan Drug Designation previously received from the FDA, WP1122 is well-positioned to be a potential treatment option for this devastating disease."
GBM is the most aggressive malignant primary brain tumor and remains as an incurable tumor with a median survival of only 15 months.1 It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors,2 and despite advancements, survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades.3 The average annual age-adjusted incidence rate of GBM is 3.19 per 100,000 persons in the United States.4
WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. Although activity in animals does not necessarily translate to humans, preclinical studies in mice transplanted with human brain tumors showed that WP1122 outperformed the standard of care, temozolomide, and performed even better in combination with temozolomide.
In September of 2022, Moleculin was granted Orphan Drug Designation of WP1122 for the treatment of GBM from the FDA. Additionally, based on preclinical data indicating the potential for WP1122 as a treatment for GBM, Moleculin received FDA clearance of its Investigational New Drug application to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM. The Company is currently evaluating opportunities for collaboration in clinical development.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Veracyte (VCYT) Announces New Data Suggesting Afirma Testing Can Help Personalize Care for Patients with Thyroid Nodules
- Altria Group (MO) Reports Q4, Announces $1B Share Buyback
- Miromatrix Medical (MIRO) receives formal clinical hold letter from the FDA
Create E-mail Alert Related CategoriesCorporate News, FDA
Related EntitiesTwitter, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!