This trial will provide us with pre- and post-treatment biopsy, immuno-profiling data as well as long-term outcome data. LSTA1 is also being evaluated in combination with gemcitabine and nab-paclitaxel in a Phase Ib/IIa open-label trial in China, led by our licensee in that territory, Qilu Pharmaceutical. During the 2023 ASCO Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study, which corroborated previously reported findings from the Phase Ib/IIa trial of LSTA1 plus gemcitabine and nab paclitaxel conducted in Australia in patients with metastatic pancreatic ductal adenocarcinoma. Final data are expected by the end of the second quarter of 2024. In collaboration with our funding partner, WARPNINE, the iLSTA trial is a Phase Ib/IIa randomized, single-blind, single-center safety and pharmacodynamic study in Australia, evaluating LSTA1 in combination with the checkpoint inhibitor, durvalumab, plus standard of care chemotherapy, nab-paclitaxel and gemcitabine versus standard of care alone in patients with locally advanced nonresectable pancreatic ductal adenocarcinoma.
Enrollment completion is expected during 2024. IGoLSTA, a Phase Ib/IIa proof-of-concept safety and early efficacy study evaluating LSTA1 in combination with nivolumab and FOLFIRINOX, as a first-line treatment in locally advanced nonresectable gastroesophageal adenocarcinoma is still pending initiation as a function of availability of funding by our partner, WARPNINE. We hope to have further update on timing related to the execution of the study in coming quarters. We are also poised to initiate the study of LSTA1 in combination with temozolomide in Glioblastoma Multiforme or GBM. This study is designed as a Phase IIa double-blind placebo-controlled randomized proof-of-concept study evaluating LSTA1 when added to standard of care temozolomide versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme.
It will be conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1, LSTA1 plus standard of care versus placebo plus standard of care. We are pleased to report that the EU clinical trial application has been approved and we expect the first patient treated before the end of this calendar year. Importantly, as recently announced, LSTA1 has been granted orphan designation by the U.S. Food and Drug Administration for malignant glioma. This action by the FDA not only highlights the unmet medical need, but also recognizes the potential of LSTA1 to benefit patients in this indication. Lastly, we also plan to initiate a study of LSTA1 in combination with hyperthermic intraperitoneal chemotherapy, more commonly referred to as HIPEC, intraoperative intraperitoneal lavage in peritoneal carcinomatosis, a cancer that develops as a result of continuous spread of primary cancers such as ovarian, colorectal and appendiceal along the peritoneum.
The study will be a Phase I single center unblinded, randomized controlled trial to determine the safety and tolerability of LSTA1, administered intraperitoneally in patients with peritoneal metastases from colorectal appendiceal or ovarian cancer undergoing cytoreductive surgery and HIPEC. 21 total participants will be randomized 2:1 to receive LSTA1 with HIPEC versus HIPEC alone after cytoreductive surgery. We anticipate the first patient will be treated in the fourth quarter of 2023. For those who are interested, a more complete description of each of our trials is available in the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are two milestone slides that depict the anticipated timing of key execution milestones and data readouts from our trials.
With that, I will now turn the call back to Dave.
Dr. David Mazzo: Thank you, Kristen. In the last three and nine months of 2023, we have made notable progress on several fronts, including the growth application of LSTA1 in combination with a variety of anticancer agents for the treatment of a variety of solid tumor types. To maximize impact and confidence in the results, we have designed our studies to be scientifically and medically rigorous and to provide results expeditiously while also assuring that we are operating in a maximally capital-efficient manner. Now with more than two years of capital available on our balance sheet, we believe we are well positioned to focus on the execution of our development plan and to achieve our goal of getting meaningful clinical data readouts as soon as possible. And with that, operator, we’re ready to take questions.
