Amplia Therapeutics Announces Opening of US Sites for Amplicity Pancreatic Cancer Trial
MWN-AI** Summary
Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF) announced the initiation of two new clinical trial sites in the United States for its AMPLICITY trial focused on advanced pancreatic cancer. The sites, located at University of California, Irvine, and The Cleveland Clinic in Cleveland, Ohio, will soon begin recruiting patients, joining two sites in Australia that are currently operational. Dr. Chris Burns, CEO of Amplia, expressed enthusiasm about the expansion, highlighting its potential to broaden the patient base and enhance the company's visibility and appeal to investors in the US market. He noted that with additional sites expected to open soon, recruitment efforts for the trial are anticipated to be more efficient.
The AMPLICITY trial investigates narmafotinib, a potent FAK inhibitor, in combination with FOLFIRINOX chemotherapy for advanced pancreatic cancer. Amplia has prioritized developing innovative treatments targeting fibrotic cancers, making them a key player in the oncology field. Narmafotinib has demonstrated promise in previous preclinical studies, notably enhancing survival rates in animal models when combined with FOLFIRINOX.
The trial will follow a structured design, including an exploration phase to determine safe dosing parameters and a subsequent efficacy comparison phase. This open-label study, which operates under the US FDA’s guidelines, is structured to maximize insights into the treatment's safety, tolerability, and overall pharmacokinetics.
Amplia’s strategic focus on expanding its clinical presence in the US positions the company to advance its innovative drug pipeline, bringing hope to patients battling challenging cancers. More comprehensive details about the AMPLICITY trial are available on its official website and related clinical trial registries.
MWN-AI** Analysis
Amplia Therapeutics’ recent announcement regarding the expansion of its AMPLICITY trial for pancreatic cancer represents a significant step forward in its clinical development efforts. The initiation of two U.S. sites at renowned institutions—University of California, Irvine and The Cleveland Clinic—along with the future addition of three more sites, greatly enhances the company’s capacity to recruit patients and could expedite the trial timeline.
In the context of investor sentiment, this expansion indicates Amplia's commitment to tapping into the lucrative U.S. oncology market, which typically offers greater financial rewards due to the larger patient pool and higher treatment costs. Given that pancreatic cancer has historically had poor survival rates, the introduction of narmafotinib, a promising FAK inhibitor, could position Amplia favorably among investors seeking biotech firms with innovative cancer treatments.
From a market perspective, this news might positively influence Amplia's stock performance, particularly if recruitment at these sites progresses smoothly and preliminary results from the trial are favorable. This is critical, as early efficacy data for narmafotinib, especially when combined with existing chemotherapy regimens like FOLFIRINOX, could generate heightened interest and valuation uplift within the biotech community.
Investors should monitor the enrollment rates and any interim results closely. Successful results in clinical trials can lead to partnerships with larger pharmaceutical companies or even acquisition interest, propelling Amplia's valuation. However, it's essential to recognize the inherent risks associated with clinical trials, including potential delays or unfavorable outcomes that could adversely impact stock prices.
In summary, Amplia Therapeutics is at a pivotal juncture. The expansion of its AMPLICITY trial offers encouraging prospects for investors, but caution is advised as the company navigates the complexities of clinical trial outcomes.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Melbourne, Australia, Feb. 11, 2026 (GLOBE NEWSWIRE) -- HIGHLIGHTS
- Two US-based sites have completed trial initiation activities for the AMPLICITY trial in pancreatic cancer
- These sites join the two Australian sites already open and recruiting patients
- Three additional US sites are expected to be open in the coming weeks
Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), announces that two (2) sites in the US have been initiated and will shortly be commencing recruitment activities for the AMPLICITY trial.
The two sites – University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) – join the two (2) sites already open in Australia as part of the Company’s AMPLICITY trial, which is investigating Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in the US will be initiated in the near future as recruitment to the trial continues.
Dr Chris Burns, CEO of Amplia, commented, “These two excellent clinical trial sites in the US help to significantly expand our potential patient base for the AMPLICITY trial, while also contributing to enhancing our presence in the United States both from a clinical and investor perspective. With these two sites, and shortly an additional three sites, we expect to be able to enroll the ongoing study as efficiently as possible. We thank the trial sites and clinical teams for their diligent efforts in completing the pre-trial activities.”
The AMPLICITY trial is investigating narmafotinib, the Company’s best-in-class FAK inhibitor, in combination with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. The trial is already open at two sites in Australia, at the Epworth Hospital (Melbourne) and Genesis Care (Sydney). Further information regarding the AMPLICITY trial can be found at the trial website amplicitytrial.com.
This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics.
ABN 16 165 160 841
+61 (0) 3 9123 1140 | info@ampliatx.com
Level 5, 90 William Street, Melbourne VIC 3000 Australia
www.ampliatx.com
| Investor Contact: Dr Chris Burns Chief Executive Officer chris@ampliatx.com U.S. Contact: Robert Giordano rjgiordano@ggrouplifesciences.com +1 917 327 3938 | Media Contact: H^CK Director, Haley Chartres haley@hck.digital +61 423 139 163 U.S. Media: media@ampliatx.com |
About Amplia Therapeutics Limited
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently being investigated in two clinical trials in pancreatic cancer. The most advanced clinical trial (ACCENT) investigates a combination with the chemotherapies gemcitabine and Abraxane® in first-line patients with advanced pancreatic cancer. The trial has already achieved its primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.7 months has also been reported.
About AMPLICITY
The AMPLICITY trial explores the safety, tolerability, efficacy and pharmacokinetics of the combination of narmafotinib with the chemotherapy regimen known as modified FOLFIRINOX in newly-diagnosed patients with advanced pancreatic cancer. The trial is entitled A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of narmafotinib in Combination with modified FOLFIRINOX in Pancreatic Cancer Patients and is being conducted under an open IND from the US FDA.
Designed as a single-arm, open-label study, the trial will proceed in two parts, incorporating the principles of the FDA's Project Optimus guidance for developing new oncology therapies. Part A will explore a range of oral daily doses of narmafotinib in combination with modified FOLFIRINOX (administered every 14 days), for safety, tolerability, and pharmacokinetics.
Part B of the trial is designed to identify the optimal daily dose of narmafotinib for future studies, by comparing two (2) doses identified from Part A, for safety, tolerability and efficacy.
The trial is being conducted initially at sites in Australia and the US. More information about the trial can be found at the Amplia Therapeutics website; ClinicalTrials.gov under the identifier NCT07026279; and at amplicitytrial.com.
The Company has previously presented data from preclinical studies demonstrating that the addition of narmafotinib to FOLFIRINOX significantly improves survival in animal models of pancreatic cancer compared to animals treated with FOLFIRINOX alone.
FAQ**
How does Amplia Therapeutics Ltd INNMF plan to leverage its presence in both the US and Australia to enhance patient recruitment for the AMPLICITY trial in advanced pancreatic cancer?
What potential market impacts could the success of narmafotinib in the AMPLICITY trial have on Amplia Therapeutics Ltd INNMF's valuation and investor interest?
What roles do the US sites at UC Irvine and The Cleveland Clinic play in advancing the research objectives of Amplia Therapeutics Ltd INNMF's AMPLICITY trial?
How will the preliminary findings from the AMPLICITY trial affect the strategic direction and future drug development pipeline of Amplia Therapeutics Ltd INNMF?
**MWN-AI FAQ is based on asking OpenAI questions about Amplia Therapeutics Ltd (OTC: INNMF).
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