AIM ImmunoTech Receives Erasmus Medical Center Ethics Board Authorization for Phase 2 Study of Ampligen® for the Treatment of Locally Advanced Pancreatic Cancer

On January 24, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that it has received authorization from the Erasmus Medical Center ("Erasmus MC") Ethics Committee to open a European site for the ongoing Phase 2 study ("AMP-270") of Ampligen as a therapy for locally advanced pancreatic cancer (Press release, AIM ImmunoTech, JAN 24, 2024, View Source [SID1234639448]).

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"Approval from the governing ethics board is an important step toward enrolling subjects in the European arm of the AMP-270 clinical trial for locally advanced pancreatic cancer," stated Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC in the Netherlands. "Erasmus MC is tracking several cancer patients that we are hopeful will be enrolled in AMP-270."

AMP-270 is a randomized, open-label, controlled, parallel-arm clinical trial with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in the United States and Europe.

For more information about AMP-270, please visit ClinicalTrials.gov and reference identifier NCT05494697.

Abbott Reports Fourth-Quarter and Full-Year 2023 Results; Issues 2024 Financial Outlook

On January 24, 2024 Abbott reported financial results for the fourth quarter ended Dec. 31, 2023 (Press release, Abbott, JAN 24, 2024, View Source [SID1234639447]).

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Fourth-quarter sales increased 1.5 percent on a reported basis, 2.1 percent on an organic basis, and 11.0 percent on an organic basis, excluding COVID-19 testing-related sales1.
Fourth-quarter GAAP diluted EPS of $0.91 and adjusted diluted EPS of $1.19, which excludes specified items.
Abbott issues full-year 2024 guidance for diluted EPS on a GAAP basis of $3.20 to $3.40 and full-year adjusted diluted EPS of $4.50 to $4.70.
Abbott projects full-year 2024 organic sales growth, excluding COVID-19 testing-related sales, to be in the range of 8.0% to 10.0%2.
In 2023, Abbott continued to recapture market share in the U.S. infant formula market. The company has now reclaimed its previous market-leading position, as measured on a volume basis.
In December, Abbott announced U.S. Food and Drug Administration (FDA) approval of its new laboratory automation system, GLP systems Track, to help laboratories optimize performance and safety to better meet the growing demand for diagnostic testing.
In January, Abbott announced that the first-in-human procedures were conducted using the company’s new Volt Pulsed Field Ablation (PFA) System to treat patients with heart rhythm disorders such as atrial fibrillation (AFib). These procedures were part of Abbott’s Volt CE Mark clinical study. Abbott anticipates approval for its U.S. clinical trial (IDE) for the Volt PFA System in the first half of 2024.
In January, Abbott announced that Tandem Diabetes Care’s t:slim X23 insulin pump is the first automated insulin delivery system in the U.S. to integrate with Abbott’s new FreeStyle Libre 2 Plus sensor.
"The strength and diversity of the Abbott portfolio drove our success in 2023," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re entering 2024 with a lot of positive momentum, and with our highly productive pipeline, we’re well-positioned for growth in 2024 and beyond."

FOURTH-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of exiting the pediatric nutrition business in China, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI), is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Johnson & Johnson Reports Q4 and Full-Year 2023 Results

On January 23, 2024 Johnson & Johnson reported fourth quarter and Full-Year 2023 Results (Press release, Johnson & Johnson, JAN 23, 2024, View Source [SID1234639453]).

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Hummingbird Diagnostics Announces Initiation of Patient Recruitment for Clinical Study Evaluating miLungDx as a Novel Diagnostic Test for Early-stage Lung Cancer

On January 23, 2024 Hummingbird Diagnostics GmbH, a leader in reading blood-based small RNAs for early disease detection and characterization, reported the initiation of its clinical study evaluating the diagnostic performance of miLungDx, a blood-based small RNA panel engineered to detect non-small cell lung cancer (NSCLC) (Press release, Hummingbird Diagnostics, JAN 23, 2024, View Source [SID1234639445]).

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The primary endpoint of the prospective, longitudinal, observational study (NCT05987189) is to detect the absence or presence of lung cancer, as determined by all follow-up imaging and pathological data obtained throughout the duration of the study. Based in the United States, the study will include 2,000 patients with the expected patient enrollment to be completed within 12 months after study initiation.

"The initiation of patient recruitment for this clinical study marks an exciting milestone for the team at Hummingbird Diagnostics and underscores our mission to improve human health through the development of novel small RNA blood tests," remarked Bruno Steinkraus, PhD, Chief Scientific Advisor of Hummingbird Diagnostics. "We believe miLungDx has the best performance reported from a blood test for early-stage lung cancer to date. We look forward to the continued development of this RNA panel."

Hummingbird Diagnostics has reported best in class performance for early detection of lung cancer published in the Journal of Thoracic Oncology and presented at ASCO (Free ASCO Whitepaper) 2023.

bioAffinity Technologies Announces Award of Therapeutic Patent for Treatment of Cancer

On January 23, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage cancer and lung disease, reported that India’s Office of the Controller General of Patents, Designs and Trade Marks has issued a Certificate of Grant of Patent to bioAffinity subsidiary OncoSelect Therapeutics, LLC for its compositions and methods to treat cancer using chemotherapeutic agents conjugated to porphyrins, resulting in targeted delivery of the drugs (Press release, BioAffinity Technologies, JAN 23, 2024, View Source [SID1234639444]).

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The Indian patent, titled "Porphyrin Compounds and Compositions Useful for Treating Cancer" is an important addition to bioAffinity Technologies’ patent portfolio, which includes 16 awarded U.S. and foreign patents and 23 pending patent applications related to its porphyrin-based diagnostic platform and cancer treatment therapeutics.

"India’s patent is an acknowledgement of the value of our ongoing research, development and commercialization of porphyrin-based diagnostics and targeted treatments for lung cancer and other diseases," bioAffinity Technologies’ President and CEO Maria Zannes said. "We are committed to improving the outcome for cancer patients around the world, beginning with lung cancer, the deadliest cancer killer. Strong intellectual property protection for our innovative science benefits not only patients in need of treatment and their physicians, but also our research team and our shareholders as well."

bioAffinity Technologies’ first product, CyPath Lung, is a porphyrin-based diagnostic test for early-stage lung cancer. Physicians use CyPath Lung for patients at high risk for developing lung cancer, often after recommended screening reveals indeterminate pulmonary lung nodules that may or may not be malignant. CyPath Lung is a noninvasive test that uses advanced flow cytometry and artificial intelligence to differentiate patients with cancer from those who do not have the disease.