SAN DIEGO, Nov. 18, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced data from two scientific posters for its Phase 2 clinical studies of VAL-083, the Company's lead compound for the treatment of glioblastoma multiforme (GBM). The data are being presented at the 26th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) being held in Boston on November 18-21, 2021.
Kintara is presenting posters on two Phase 2 clinical studies evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:
Poster CTNI-21: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated GBM"
The first poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients conducted at Sun Yat-sen University Cancer Center in China.
For the 25 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, progression free survival (PFS) was 8.7 months (95% confidence interval: CI 6.4-12.5) and median overall survival (mOS) was 19.1 months (CI 12.0-22.3). While not a head-to-head study, this compares favorably to historical temozolomide (TMZ) control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.
The poster also highlights a case report from the study for a patient who remains progression free for more than 37 months after diagnosis. All patients have completed treatment. Adverse events have been consistent with prior studies with myelosuppression being the most common adverse event.
Poster CTNI-26: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT unmethylated, bevacizumab naïve glioblastoma in the adjuvant or recurrent setting"
The second poster outlined the two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM being conducted at the MD Anderson Cancer Center in Houston.
In the recurrent group, for the 48 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, mOS was 8.0 months (CI 6.6-10.3). While not a head-to-head study, this compares favorably to historical lomustine control mOS of 7.2 months**.
In the adjuvant group, for the 36 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, PFS was 9.5 months (CI 8.2-10.8) and mOS was 16.5 months (CI 13.6-19.3). While not a head-to-head study, this compares favorably to historical TMZ control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.
All patients have completed treatment. Consistent with prior studies, myelosuppression was the most common adverse event in both recurrent GBM and in the adjuvant setting.
*Hegi et al N Eng J Med (2005); Tanguturi et al. NeuroOncol (2017); Alnahhas et al. Neurooncol Adv (2020)
** Wick et al N.Eng.J.Med (2017)
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for CMBC.
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting its GBM AGILE study to support the development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with 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.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2021, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.