A study led by Nagoya University in Japan has identified three previously unknown membrane proteins in ovarian cancer. Using a unique technology consisting of nanowires with a polyketone coating, the group succeeded in capturing the proteins, demonstrating a new detection method for identification of ovarian cancer. The study is published in the journal Science Advances. The discovery of new biomarkers is important for detecting ovarian cancer, as the disease is difficult to detect in its early stages where it can most easily be treated. One approach to detecting cancer is to look for extracellular vesicles (EVs), especially small proteins released from the tumor called exosomes. As these proteins are found outside the cancer cell, they can be isolated from body fluids, such as blood, urine, and saliva. However, the use of these biomarkers is hindered by the lack of reliable ones for the detection of ovarian cancer. A research group led by ...
The US Food and Drug Administration (FDA) has granted an orphan drug designation to ImPact Bio’s padeliporfin vascular targeted photodynamic therapy (VTP) for patients with locally advanced pancreatic cancer. Israel-headquartered ImPact Bio expects to submit an investigational new drug application (IND) later in 2023, with a Phase I trial of the treatment in patients with locally advanced pancreatic ductal adenocarcinoma also scheduled for this year, per a 5 July press release. Orphan drug designations come with certain benefits such as granting tax credits for US-based clinical trials and recommendations from the FDA on the required clinical and preclinical studies. Padeliporfin VTP is based on the combined use of the drug padeliporfin and non-thermal laser light. The drug is administered intravenously to a patient after which it is activated by a non-thermal laser light in the specific area of the tumour, per the company’s website. The light results in the drug’s ...
Drug shortages have been in the news for several years, but they worsened during the Covid-19 pandemic, and several pharmacy, regulatory, and physician organisations, in the US and Europe, have recently issued alerts in response. In May, the American Cancer Society declared that chemotherapy drugs were among the top-five drug classes affected by shortages, and numerous oncology medications are currently in short supply according to data from the US Food and Drug Administration (FDA). “The shortages of oncology drugs are primarily in the generic drug market,” says Dr. Kevin Shulman, a professor of medicine and clinical hospitalist at the Clinical Excellence Research Center at Stanford University. There is no financial incentive for big pharma to manufacture older generic medications that are critical to the treatment of several common cancers and very few companies invest in doing so, says Dr. Kristen Rice, medical oncologist with a practice in San Diego, California. ...
AstraZeneca has announced impressive results for its STRIDE regimen, delivering significantly improved outcomes for advanced liver cancer patients. The treatment regimen was evaluated in the ongoing HIMALAYA Phase III study (NCT03298451), conducted with 1324 hepatocellular carcinoma (HCC) patients. Participants were randomised to receive either STRIDE or sorafenib, one of the tyrosine kinase inhibitors that comprise the current standard of care for various liver, kidney, and thyroid cancers. After four years of follow-ups, AstraZeneca announced that STRIDE reduced the risk of death by 22% compared to sorafenib, with 25.2% of patients alive at the four-year mark compared to 15.1% with sorafenib. While a one-in-four survival rate may not be comparable, advanced-stage HCC carries a poor prognosis. Five-year survival rates for the condition are only 7%, one of the lowest across all oncology, so even minor improvements in overall survival can make a major difference. Despite this improvement, adverse events recorded during ...
Lisata Therapeutics aims to start a new Phase Ib/IIa trial of its lead candidate drug LSTA1 in glioblastoma later this year. The trial will study LSTA1’s use alongside the standard of care (SOC) versus the SOC and placebo. According to Lisata CEO David Mazzo, added that the company aims to enrol 30 subjects in the active arm in approximately one year. The study will focus on efficacy endpoints such as progression-free survival and overall survival. The trial will take place in the Baltic region, specifically in Estonia and Latvia. This was initially shaped by the company’s collaboration with a research group from Estonia’s University of Tartu Mazzo commented that Lisata aims to have data from this trial ready by mid-2025. The company’s lead candidate LSTA1 is a cyclic peptide that is designed to modify the tumour microenvironment by binding to alpha-V integrins expressed in tumours, per the company’s website. Once ...
By monitoring early-response biomarkers in men undergoing 177Lu-PSMA prostate cancer treatment, physicians can personalize dosing intervals, significantly improving patient outcomes. In a study presented at the Society of Nuclear Medicine and Molecular Imaging 2023 Annual Meeting, early stratification with 177Lu-SPECT/CT allowed men responding to treatment to take a “treatment holiday” and allowed those not responding the option to switch to another treatment. Approved by the U.S. Food and Drug Administration in 2022, 177Lu-PSMA is an effective treatment for metastatic castration-resistant prostate cancer. However, not all men respond equally to treatment, with some responding very well and others progressing early. “Currently, a standardized dosing interval is used for 177Lu-PSMA treatment,” said Andrew Nguyen, MBBS, FRACP, AANMS, senior staff specialist in the Department of Theranostics and Nuclear Medicine at St. Vincent’s Hospital in Sydney, Australia. “However, monitoring early-response biomarkers to adjust treatment intervals may improve patient outcomes.” In the study, researchers sought ...
By Tristan Manalac www.biospace.com Pictured: FDA Building/courtesy of Grandbrothers/Adobe Stock The FDA has placed Mersana Therapeutics’ UP-NEXT and UPGRADE-A trials on partial clinical hold, the company announced Thursday. Both studies evaluate Mersana’s investigational antibody-drug conjugate upifitamab rilsodotin in platinum-sensitive ovarian cancer. The regulatory pause was triggered by an aggregate safety report containing information from around 560 patients who had received upifitamab rilsodotin (UpRi). Mersana’s data showed a higher rate of serious bleeding events, though most of these episodes were low-grade. Still, five cases of serious bleeding were fatal. The exact causes of bleeding are still unknown and are currently being investigated. Mersana’s stocks fell 60% in pre-market trading Thursday in response to the news. The FDA has yet to provide Mersana with a formal written communication regarding the partial clinical hold. However, the company expects the regulator to request a more comprehensive evaluation of UpRi’s safety data. Mersana is working ...
By Neha Mathur Reviewed by Benedette Cuffari, M.Sc. In a recent article published in the Journal of Clinical Oncology, researchers reveal significant cost savings when generic oncology drugs are purchased through the Mark Cuban Cost Plus Drug Company (MCCPDC) as compared to Medicare. Study: Projected Savings for Generic Oncology Drugs Purchased via Mark Cuban Cost Plus Drug Company Versus in Medicare. Image Credit: Celil Kirnapci / Shutterstock.com Background There is an urgent need to reduce spending across the system in a dynamic healthcare landscape like that of the United States, which is possible with the equal participation of patients and sponsors. The Medicare program contributes a substantial proportion of prescription drug spending in the U.S., which was already high and continues to increase over time. In fact, in 2019, Medicare and its beneficiaries accounted for 27.2% of the fee-for-service program. Although oncology prescription drugs constituted only 0.6% of overall sales ...
Prostate cancer is the most-commonly diagnosed malignancy and the second leading cause of cancer death among men in the United States. In its ever-indelicate world, the stubborn disease can continue to grow even when the amount of testosterone in the body is reduced to very low levels, thus earning the clumsy name: castrate-resistant prostate cancer (CRPC). It poses a major clinical challenge as a protein called the androgen receptor (AR) remains behind as a critical player in cancer, changing its behavior in CRPCs. Androgen-deprivation therapy, which is a treatment that reduces the levels of male hormones, is the first-line treatment for locally advanced or metastatic prostate cancer. Despite initial responses to the therapy, nearly all patients eventually develop CRPC within a few years. It is now well recognized that CRPC continues to be dependent on AR signaling. “Understanding the triggers that cause changes in AR’s activity is important for developing ...
Researchers at the Francis Crick Institute and King’s College London have revealed the complex interactions between cancer and the immune cells that surround a tumor, with the potential to inform how patients will respond to immunotherapy.In the study, published in the journal Genome Medicine, the researchers analyzed thousands of samples across 32 types of cancer to examine the way that cancer dynamically interacts with the tumor immune microenvironment (TIME), allowing the disease to flourish. Cancer evolves within the TIME, which is sculpted by cancer cells and, in turn, sculpts the cancer genome. These dynamic interactions have a significant impact on how the cancer develops and responds to treatments such as immunotherapy. Gaining a greater understanding of cancer-immune system interaction is therefore crucial to understanding cancer biology. The researchers focused on a class of genes called cancer drivers because, when altered, they help drive cancer. They identified 477 of these cancer ...
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