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Immunicum AB (publ) Announces Completion of HCC Phase I/II Clinical Study | |||
By: Nasdaq / GlobeNewswire - 28 Sep 2017 | Back to overview list |
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Press Release28 September 2017 Immunicum AB (publ) Announces Completion of HCC Phase I/II Clinical Study--Topline Safety and Immune Response Data Support Continued Development of Ilixadencel in Liver Cancer--Immunicum AB (publ; First North Premier: IMMU.ST) a biopharmaceutical company advancing a novel immune-priming cancer treatment against a range of solid tumors, today announced positive topline results from the completed Phase I/II safety and tolerability clinical trial of lead drug candidate, ilixadencel, in 18 advanced liver cancer patients. Ilixadencel was shown to be safe and well tolerated in these patients when given both as a single treatment and in combination with the current first line standard of care treatment, sorafenib. In addition, the results provide evidence of tumor-specific immune activation in the majority of patients. Based on these positive data, Immunicum continues preparation for the next stage of clinical development, in which one focus will be on establishing ilixadencel's efficacy in treating liver cancer. Ilixadencel is a cell-based, off-the-shelf therapy designed to prime the patient's immune system to recognize and destroy cancer cells, overcoming the tumor cell's ability to avoid immune system detection and attack. Advanced liver cancer, specifically metastatic hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA, also known as bile duct cancer), is an aggressive and difficult to treat form of cancer with high mortality rates and short time to death*. Currently available treatment options including chemotherapy, molecular targeted therapy, local interventional hepatic therapy or surgery, have limited impact in patients with advanced disease. These treatments are also constrained because liver cancer patients have low tolerance for treatments with high levels of toxicity. Priming the immune system to attack a tumor holds promise of offering increased therapeutic impact with reduced side effects.
Study Design
The final patient disposition was as follows: 7 patients were treated with ilixadencel as second line treatment, 10 patients were treated as first line treatment of which 6 patients were treated in combination with sorafenib. 14 patients received all three injections.
There were no life-threatening or fatal treatment-related adverse events (AEs). Overall, with only one exception, all treatment-related AEs were mild-to-moderate in Common Terminology Criteria for Adverse Events grading (grade 1 - 2). The most common treatment-related AEs were described as fever and/or chills and could be easily managed. The exception was one patient receiving ilixadencel and sorafenib as combination therapy, who presented with a suspected sepsis event (grade 3) that subsequently recovered. As a reference, current standard of care, such as sorafenib or regorafenib, report in the literature and in prescribing information severe (grade 3) drug-related AEs in at least one in three HCC patients treated. "The most important results of this phase of clinical development are the safety data and these provide us with a solid basis on which to continue testing ilixadencel as a potential treatment for advanced liver cancer, an indication with desperate need of additional therapies," said Peter Suenaert, MD, PhD, Chief Medical Officer at Immunicum. "The final topline results remain in line with our previously reported data, and we are very excited to conclude the study with this outcome. We look forward to the opportunity to publish the final data analysis from the study in a peer-reviewed scientific journal."
Results - Main Exploratory Endpoints
"The excellent safety observed in this trial, as in previous studies, support our overall strategy for ilixadencel as a possible backbone in solid tumor cancer treatment that can prime the immune system while being safe and well tolerated by patients. Beyond the safety profile, the immunological data confirm our mechanism of action and support our plans to move ilixadencel forward in HCC, an important part of our clinical development strategy," said Carlos de Sousa, MD, CEO of Immunicum. "We thank our clinical development team, the clinicians, the patients and their families involved in the study for their support."
* Bruix J et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial; The Lancet Published online December 5, 2016
About hepatocellular carcinoma
About ilixadencel
About Phase I/II clinical trials
The information is such information that Immunicum is obliged to make public pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company's contact person on September 28, 2017 at 8:00 am CET. For more information, please contact:
Carlos de Sousa, CEO, Immunicum
Investor relations, Sweden
Helena Stångberg
Investor and Media Relations EU/US
MacDougall Biomedical Communications
The Company's Certified Adviser is Redeye AB
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Immunicum AB via GlobeNewswire
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Copyright 2017 Nasdaq / GlobeNewswire | Back to overview list |