SAN DIEGO, Nov. 9, 2021 /PRNewswire/ -- https://www.kintara.com/ /zigman2/quotes/209332458/composite KTRA -4.85% ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that Robert E. Hoffman, the Company's Chairman, will succeed Saiid Zarrabian as President and Chief Executive Officer, effective November 8, 2021. Mr. Hoffman will continue in his capacity as the Company's Chairman, and Mr. Zarrabian will transition to heading up Kintara's strategic partnerships initiative and will remain a member of the Board of Directors.
"On behalf of the Board and the entire Kintara team, I wish to extend gratitude to Saiid for the tremendous impact he has made on the Company since joining the Board in 2017, and ultimately, taking over the helm of CEO back in 2018," commented Robert E. Hoffman, Kintara's President, Chief Executive Officer and Chairman. "Over the past few years, it was Saiid who led the effort to streamline and strengthen Kintara's operational foundation and product pipeline with the addition of REM-001, while also advancing multiple clinical trials for our platform asset VAL-083 highlighted by its participation in GCAR's GBM AGILE study. This is a transformational opportunity for the Company as the GCAR study is an FDA-approved registrational trial which is cost-effective through its expense-sharing protocol that is designed to greatly accelerate VAL-083's timeline for regulatory submission perhaps by up to 18 months. This is only one of many important milestones accomplished during Saiid's tenure as CEO, and I look forward to working with him to explore all that is possible for VAL-083 to help patients and to generate shareholder value."
"It has been a pleasure serving as CEO and I'm thrilled to transition the post to Robert, as he brings an ideal operational and commercial leadership profile to the role, which is now needed as Kintara prepares for its next phase of growth given VAL-083 is entering the final stages of clinical development for the GBM indication," commented Saiid Zarrabian, Kintara's Head of Strategic Partnerships and member of the Board of Directors. "I joined Kintara based on my belief in VAL-083's potential to be a game-changing therapeutic agent. Now that the Company is well-positioned to execute on its near-term clinical plan, I'm excited to dedicate my energy to working with Robert, my fellow Board members, and the entire Kintara team to explore potential strategic partnerships for VAL-083 and REM-001 for multiple oncology indications."
Robert E. Hoffman has served as a director of Kintara since April 2018 and Chairman since June 2018. He currently serves as a Board member of Aslan Pharmaceuticals, Inc., Antibe Therapeutics, Inc., and Saniona AB. Mr. Hoffman's previous experience includes serving as Senior Vice President and Chief Financial Officer of Heron Therapeutics from April 2017 to October 2020. Mr. Hoffman was part of the founding management team of Arena Pharmaceuticals, Inc. in 1997, serving in various roles until 2015, including Senior Vice President, Finance and Chief Financial Officer. Mr. Hoffman served as a member of the Financial Accounting Standards Board's Small Business Advisory Committee. Mr. Hoffman holds a B.B.A. from St. Bonaventure University.
About the GBM AGILE Study and The Global Coalition for Adaptive Research (GCAR)
The GBM AGILE study is a revolutionary, patient-centered, adaptive platform trial for registration, evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. VAL-083 currently represents the only therapeutic agent being evaluated in all subgroups of GBM AGILE (newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent patients). The study will enroll up to 150 patients in the initial evaluation (labeled 'stage 1') for the VAL-083 arm of the study at over 40 sites in the U.S. and Canada, with potential to increase to 65 clinical trial centers worldwide. Kintara has sufficient funding through stage 1, which could result in graduation to the final confirmatory stage, the potential NDA-enabling portion of the study. A key benefit to participating in the GBM AGILE Study is that it may accelerate VAL-083's time to pivotal trial completion and potential regulatory submission by up to 18 months. As of August, 2021, 26 U.S. clinical sites have been activated.
GCAR is a 501(c)(3) nonprofit organization, comprised of some of the world's foremost physicians, clinical researchers and investigators united in expediting the discovery and development of cures for patients with rare and deadly diseases. Key strategic partners for its GBM AGILE study effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research.
Located in San Diego, California, Kintara /zigman2/quotes/209332458/composite KTRA -4.85% is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute. Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.
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.
Safe Harbor Statement
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.
EVP, Head of Communications
SOURCE Kintara Therapeutics
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