Kintara Therapeutics is developing innovative cancer therapies for rare, unmet medical needs
- Kintara Therapeutics says VAL-083 treatment arm in the Phase 2/3 clinical trial for glioblastoma multiforme now activated in 26 US sites
- Kintara Therapeutics enrolls patients at 26 sites within around 7 months
Quick facts: Kintara Therapeutics
Price: 1.34 USD
Market Cap: $43.71 m
About the company
intara Therapeutics, Inc is developing advanced cancer therapies for patients with rare unmet medical needs. The company is currently developing two Phase 3-ready therapeutics: VAL-083 for treating glioblastoma (GBM), the most common and most aggressive form of primary brain cancer in adults and; REM-001 for treating cutaneous metastatic breast cancer (CMBC).
VAL-083 is considered a first-in-class, DNA-targeting small molecule, mechanisms of action (MOA) in addendum, which is designed to cross the blood-brain barrier. It has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors in clinical trials sponsored by the US National Cancer Institute (NCI). It has been granted Orphan Drug Designation for GBM by the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer from the FDA. As well, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
REM-001 therapy, meanwhile, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC, who had previously received chemotherapy and/or failed radiation therapy. The MOA is similar to radiation therapy via the creation of oxygen radicals. With clinical efficacy of 80% complete responses of evaluable CMBC lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
How it is doing
Kintara Therapeutics (NASDAQ:KTRA) Inc has announced that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has now been activated in 26 US sites as of August 16, 2021.
The GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) trial is a patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly diagnosed and recurrent GBM.
Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara's arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the US and Canada with the potential to increase that total to 65 clinical trial centers worldwide.
"The entire Kintara team remains enthused by the pace at which our treatment arm is being activated in the study," said Kintara CEO, Saiid Zarrabian in a statement. "With 26 sites already active, including the recent addition of prestigious centers such as the Dana Farber Cancer Institute and Massachusetts General Hospital, we are delighted to witness GCAR's exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."
Kintara Therapeutics Inc (NASDAQ:KTRA) (FRA:3DM) (OTCMKTS:DMPWW) has announced topline data results from the recurrent arm of its open-label, Phase 2 clinical study of its lead compound VAL-083 being conducted at the MD Anderson Cancer Center in Houston.
The Phase 2 trial is a two-arm, biomarker-driven study testing VAL-083 in glioblastoma multiforme (GBM) patients, who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The recurrent arm of the study addressed patients who have been pre-treated with temozolomide prior to disease recurrence.
Kintara Therapeutics Inc (NASDAQ:KTRA) (OTCMKTS:DMPWW) (FRA:3DM), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, has announced its addition to the Russell Microcap Index.
The company said its addition will take place at the conclusion of the 2021 Russell Indexes' annual reconstitution, effective after the US market opens on June 28, according to a preliminary list of additions posted on June 4.
What management says
Kintara Therapeutics (NASDAQ:KTRA) Inc (NASDAQ:KTRA) CEO Saiid Zarrabian tells Proactive its VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has now been activated in 26 US sites.
Zarrabian explains why speed of site enrollment is so important, and how the group managed to establish enrollment at sites within a span of a seven months. He says typically, it will take around 2 years to enroll at these kind of sites.
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