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First-in-human Study of Precision Immune Stimulant PIN-2 Demonstrated Pharmacologic Activity and Safety in Patients with Advanced Solid Tumors

In Clinical Trials by Barbara Jacoby

Source: PIN Pharma, Inc. From: argus-press.com PIN Pharma, Inc., today announced final results of a first-in-human clinical trial of its novel immunomodulating agent PIN-2 in subjects with advanced solid tumors. This was an open-label, repeat-dose study with a primary objective to assess the pharmacodynamic activity of PIN-2. Pharmacodynamic biomarkers that signal changes in the human immune system were used to …

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FDA Grants Priority Review Designation for Heron Therapeutics’ NDA for HTX-011, a Non-Opioid for Postoperative Pain Management

In Clinical Trials by Barbara Jacoby

Source: Heron Therapeutics, Inc. From: prnewswire.com Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for Heron’s investigational agent, HTX-011, and has …

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JHL Biotech Announces First Patient Randomized in the Phase III Study of JHL1101 to Treat Diffuse Large B-Cell Lymphoma

In Clinical Trials by Barbara Jacoby

Source: JHL Biotech From: prnewswire.co.uk JHL Biotech announced today that the first patient at Beijing Cancer Hospital has been successfully randomized in the Phase III study of JHL1101 to treat diffuse large B-cell lymphoma (DLBCL). The Phase III study is a multinational, randomized, double-blind, positive-controlled, parallel group clinical study.  It compares the efficacy and safety of JHL1101 in combination with CHOP …

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Breast cancer drugs could help treat therapy-resistant lung cancers

In Clinical Trials by Barbara Jacoby

Source: PTI | London From: theweek.in A class of drugs used to treat certain breast cancers could help fight lung cancers A class of drugs used to treat certain breast cancers could help fight lung cancers that have become resistant to targeted therapies, according to a study conducted in mice. The study, published in the journal Cell Reports, found that …

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Mayo researchers ID potential new treatment for one type of triple-negative breast cancer

In Clinical Trials by Barbara Jacoby

Source: Mayo Clinic From: eurekalert.org Mayo Clinic researchers have identified the drug estradiol as a potential new treatment for a subset of women with triple-negative breast cancer. Their findings are published in the Proceedings of the National Academy of Sciences of the United States of America. “Triple-negative breast cancer is a form of breast cancer that lacks expression of estrogen …

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City of Hope opens CAR T trial for HER2 breast cancer patients with brain metastases

In Clinical Trials by Barbara Jacoby

Source: City of Hope From: eurekalert.org City of Hope opens first-of-its-kind CAR T clinical trial for patients with HER2-positive breast cancer that has spread to the brain The immunotherapy trial is the first to deliver CAR T cells directly to the brain of HER2-positive breast cancer patients with brain metastases DUARTE, Calif. — Women with HER2-positive breast cancer that has …

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Researchers Suggest Current Methods for Reporting Toxicities in Cancer Clinical Trials are Falling Short

In Clinical Trials by Barbara Jacoby

Findings published in JNCCN examine the differences between patient- and clinician-reported outcomes; recommend a greater focus on the cumulative effect of multiple low-level toxicities. New research from Europe, published in the December 2018 issue of JNCCN—Journal of the National Comprehensive Cancer Network, finds that quality-of-life for people with cancer is reduced by an accumulation of low-level toxicities just as much …

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Lilly announces publication of analyses showing benefit of the addition of Verzenio® (abemaciclib) in multiple subgroups of patients with advanced breast cancer identified as having a more concerning prognosis

In Clinical Trials by Barbara Jacoby

Source: PRNewswire From: biospace.com Subgroup analyses demonstrate consistent benefit in subgroups of patients with a more concerning prognosis such as those with liver metastases, PR-negative disease, high tumor grade, or shorter treatment-free interval Eli Lilly and Company (NYSE: LLY) today announced npj Breast Cancer published results from exploratory subgroup analyses of the MONARCH 2 and MONARCH 3 trials reinforcing the clinical …

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Oncology Venture receives positive feed-back from the FDA on approval pathway for LiPlaCis and DRP in the US

In Clinical Trials by Barbara Jacoby

From: ptcommunity.com Oncology Venture A/S (“OV” or the Company) today announced that the US Food and Drug Administration, FDA has responded positively on questions posed by the company in a Pre-IND/IDE package for the approval pathway for LiPlaCis® and its companion diagnostic DRP® – Drug Response Predictor – in metastatic breast cancer. Hørsholm, Denmark and Cambridge, MA, US, December 18, …

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Puma Biotechnology Announces Top Line Results of the Phase III NALA Trial of Neratinib in Patients with HER2-Positive Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

SOURCE: Puma Biotechnology, Inc. From: apnews.com Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced top line results from the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease. The Phase …