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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aileron Therapeutics Inc | NASDAQ:ALRN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.06 | -1.57% | 3.76 | 3.74 | 3.85 | 4.17 | 3.75 | 3.79 | 142,724 | 22:08:25 |
The Phase 1b, open-label, single-armi, multicenter trial is designed to evaluate the safety, tolerability and chemoprotective effect of ALRN-6924 in up to 24 patients with p53-mutated breast cancer undergoing either neoadjuvant or adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide, also known as TAC. The primary endpoints are duration and incidence of severe neutropenia (Grade 4) in cycle 1. Secondary endpoints include the chemoprotective effect of ALRN-6924 on chemotherapy-induced alopecia, as well as other hematologic and non-hematologic toxicities. TAC will be administered every 3 weeks for 4 to 6 cycles based on investigators’ discretion. ALRN-6924 will be administered at 1.2 mg/kg on 3 consecutive days in each treatment cycle, Days 0, 1 and 2, while chemotherapy will be administered on Day 1.
“Our team has worked methodically and expeditiously to modify the Phase 1b breast cancer trial in order to enhance our opportunity to demonstrate a robust chemoprotective effect of ALRN-6924 in patients with p53-mutated breast cancer. The evidence-based modifications we are implementing reflect key, collective learnings from our healthy volunteer study, as well as our non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) clinical trials. We are also expanding the eligibility criteria and plan to activate additional sites in additional countries, which we believe will help ensure we are able to recruit the targeted number of patients in a timely and cost-efficient manner,” said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron.
Dr. Aivado continued, “We have been closely evaluating operations and have successfully identified cost efficiencies that we’ve already begun to implement. With our decision to cease enrollment in our NSCLC trial last month, and the cash preservation measures we have identified, we believe that our cash resources will now fund our continued operations through the end of the first quarter of 2024. We expect that this will allow us to get to topline readouts for the breast cancer trial next year and if warranted by the trial results, to initiate preparation for a potential pivotal trial.”
Nashat Gabrail, M.D., founder of the Gabrail Cancer Center in Canton, Ohio, President of Innovative Community Oncology Practices (ICOP), and the U.S. lead investigator in the ALRN-6924 breast cancer trial commented, “We are excited to continue our participation in this important clinical trial of ALRN-6924 in patients with p53-mutated breast cancer, and we fully support the protocol enhancements. Protecting cancer patients from chemotherapy-induced toxicities remains a critical unmet need. For bone marrow toxicities, such as neutropenia, existing treatments are often not effective and are associated with significant drawbacks. For other side effects, such as alopecia, there currently are no pharmacological options. We look forward to the continued clinical investigation of this potentially transformative therapy to prevent multiple chemotherapy-induced side effects and help patients fight cancer more effectively.”
The Gabrail Cancer Center is part of the Sargon Research network, comprising community oncology practices throughout the U.S., whose goal is to drive critical oncology research in the community oncology setting. Five of the Sargon Research network sites, in addition to the Gabrail Cancer Center, will participate in the Aileron breast cancer trial.
Key Enhancements to ALRN-6924 Breast Cancer Trial Design and Study Conduct
About Aileron Therapeutics Aileron is a clinical stage chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives. ALRN-6924, our first-in-class MDM2/MDMX dual inhibitor, is designed to activate p53, which in turn upregulates p21, a known inhibitor of the cell replication cycle. ALRN-6924 is the only reported chemoprotective agent in clinical development to employ a biomarker strategy, in which we exclusively focus on treating patients with p53-mutated cancers. Our targeted strategy is designed to selectively protect multiple healthy cell types throughout the body from chemotherapy without protecting cancer cells. As a result, healthy cells are spared from chemotherapeutic destruction while chemotherapy continues to kill cancer cells. By reducing or eliminating multiple chemotherapy-induced side effects, ALRN-6924 may improve patients’ quality of life and help them better tolerate chemotherapy. Enhanced tolerability may result in fewer dose reductions or delays of chemotherapy and the potential for improved efficacy.
Our vision is to bring chemoprotection to all patients with p53-mutated cancers, which represent approximately 50% of cancer patients, regardless of type of cancer or chemotherapy. Visit us at aileronrx.com to learn more.
Forward-Looking Statements Statements in this press release about Aileron’s future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the potential of ALRN-6924 as a chemoprotective agent, the Company’s strategy, the Company’s clinical development plans, including the design of the Phase 1b trial referred to in this release, and the Company’s cash runway. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Aileron’s cash resources will be sufficient to fund its continuing operations for the periods anticipated or with respect to the matters anticipated; whether the cash preservation measures referenced in this release will result in the savings anticipated; whether the modifications to the Phase 1b trial referred to in this release will have the effects anticipated; whether preclinical or clinical results will be indicative of results obtained in future clinical trials, including trials in different indications or with different chemotherapies; whether ALRN-6924 will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will be accepted by and warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether ALRN-6924 will receive approval from regulatory agencies on a timely basis or at all or in which territories or indications ALRN-6924 may receive approval; whether, if ALRN-6924 obtains approval, it will be successfully distributed and marketed; what impact the coronavirus pandemic may have on the timing of our clinical development, clinical supply and our operations; and other factors discussed in the “Risk Factors” section of Aileron’s annual report on Form 10-K for the year ended December 31, 2021, filed on March 28, 2022, and risks described in other filings that Aileron may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.
Investor Contact: | Media Contact: |
Stern Investor Relations | Aileron Therapeutics |
Alexander Lobo | Liz Melone |
alex.lobo@sternir.com | lmelone@aileronrx.com |
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i The original ALRN-6924 breast cancer trial design included a control cohort, given lack of relevant historical controls. In the updated trial design, the control cohort has been removed since Aileron can now leverage as historical controls established third-party clinical data from previous trials that utilized the same primary endpoint and chemotherapy regimen. ii Andric et al., ESMO 2021 iii U.S. Food & Drug Administration (FDA) Statistical Review of FULPHILA® iv ZARXIO®, FULPHILA® and ZIEXTENZO® v NEULASTA®, FULPHILA® and ZIEXTENZO®
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