Breaking News
January 18, 2019 - Let’s map our DNA and save billions each year in health costs
January 18, 2019 - AI demonstrates potential to identify irregular heart rhythms as well as humans
January 17, 2019 - Study shows link between air pollution and increased risk of sleep apnea
January 17, 2019 - Neck-strengthening exercises can protect athletes from concussions
January 17, 2019 - Computer model shows how to better control MRSA outbreaks
January 17, 2019 - Pain is unpleasant, and now scientists have identified the set of responsible neurons
January 17, 2019 - CUIMC Celebrates 2018-2019
January 17, 2019 - Study reveals potential pathway for endothelial cells to avoid apoptosis
January 17, 2019 - Hamilton Storage launches LabElite DeCapper SL to expand LabElite product family
January 17, 2019 - Location of epigenetic changes co-locate with genetic signal causing psychartric disorder
January 17, 2019 - Researchers awarded 6.1 million euros to address female fertility problems
January 17, 2019 - Counseling appointments fail to reduce weight gain during pregnancy, shows study
January 17, 2019 - Contraceptive patch that could provide 6 months of contraception within seconds
January 17, 2019 - Yeast model may pave way for development of novel therapies for metabolic disorders
January 17, 2019 - Study determines impact of antibiotic perturbation of the gut microbiome on skeletal health
January 17, 2019 - Cardiometabolic Risk Up With Tourette, Chronic Tic Disorder
January 17, 2019 - Hong Kong scientists claim ‘broad-spectrum’ antiviral breakthrough
January 17, 2019 - Researchers discover the brain cells that make pain unpleasant | News Center
January 17, 2019 - Hepatitis Is Common in New Cancer Patients
January 17, 2019 - Podcast: KHN’s ‘What The Health?’ Drug Prices Are Rising Again. Is Someone Going To Do Something About It?
January 17, 2019 - Smoking significantly increases your biological age, study shows
January 17, 2019 - B-group vitamins may be beneficial for people with first episode psychosis
January 17, 2019 - Researchers demonstrate how manganese produces parkinsonian syndrome
January 17, 2019 - Researchers suggest link between personality type and attitude towards others’ bodies
January 17, 2019 - Mutant mice administered with cocaine failed to exhibit hyperactivity, shows study
January 17, 2019 - Health Tip: Understanding a Heart Murmur
January 17, 2019 - Gut protein mutations shield against spikes in glucose
January 17, 2019 - Engineered immune cells target broad range of pediatric solid tumors in mice | News Center
January 17, 2019 - Study finds link between high pesticide exposure and poor sense of smell among farmers
January 17, 2019 - Many cancer patients have undiagnosed hepatitis
January 17, 2019 - New study finds only 13% of outpatient antibiotic prescriptions to be appropriate
January 17, 2019 - Stem cell-based approach to diabetes offers hope for treatment
January 17, 2019 - New project receives €8.65 million from EU and Canada to ease genomic, health data sharing
January 17, 2019 - Improvements in pharmacological study to fight cognitive impairment in schizophrenia
January 17, 2019 - Study looks at trends over time in oral antibiotic prescribing by dermatologists
January 17, 2019 - Most substance use disorder treatment facilities do not offer medication treatment
January 17, 2019 - Multiple sclerosis could benefit from stem cell therapy
January 17, 2019 - Researchers manipulate T cells to improve transplant success
January 17, 2019 - Put away your rulers and reach for your phone
January 17, 2019 - Mindfulness linked with fewer menopausal symptoms
January 17, 2019 - Integrated care to women with PMADs offered at several levels
January 17, 2019 - Researchers identify MANF as a rejuvenating factor in parabiosis
January 17, 2019 - Truncal mutations study suggests new direction in origins of cancer
January 17, 2019 - Beckman Coulter launches new ClearLLab 10C System for clinical flow cytometry lab
January 17, 2019 - Effects of linoleic acid on the body are largely dependent on genes, shows study
January 17, 2019 - Pre-injury exercise reduces damage to both muscles and nerves, study finds
January 17, 2019 - Minimizing Antibody Size to Maximize Research Potential
January 17, 2019 - Research finds large genome in tiny forest defoliator
January 17, 2019 - Technology helps reduce the yearning for unhealthy food
January 17, 2019 - Imec develops prototype cardiovascular device
January 17, 2019 - New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
January 17, 2019 - What you should know about teeth whitening
January 17, 2019 - Why Older Adults Should Eat More Protein (And Not Overdo Protein Shakes)
January 17, 2019 - Colorectal cancer mortality rates predicted to increase globally
January 17, 2019 - Scientists discover mutational signatures of tumor hypoxia
January 17, 2019 - New evidence shows how fever alters immune cells
January 17, 2019 - Researchers find new class of blood pressure-regulating peptides in vampire bat venom
January 17, 2019 - Promega to exhibit new Maxwell RSC48 platform at 2019 Festival of Genomics
January 17, 2019 - Study pinpoints immune cells that could be key to tackling hypertension
January 17, 2019 - Couples Intervention May Aid Partners of Diabetes Patients
January 17, 2019 - Your weight history may predict your heart failure risk
January 17, 2019 - Explore a cornucopia of accomplishments in prematurity research
January 17, 2019 - New study identifies four characteristics that predict severity of postpartum depression
January 17, 2019 - AHF urges United Nations to follow own mandate for protecting Ebola response efforts
January 17, 2019 - New, scalpel-free treatment for reducing Parkinson’s tremor gets FDA approval
January 17, 2019 - Neurobiologists uncover key component of how the human brain marks time
January 17, 2019 - LifeTime receives fund to develop a plan to embed its vision for healthier future
January 17, 2019 - WTC first responders at higher risk for head and neck cancers, study finds
January 17, 2019 - New NSF funded study may help physicians decrease brain injury deaths
January 17, 2019 - Ham bones contain peptides that could have cardioprotective effects
January 17, 2019 - Research finds how Candida albicans adapt to low oxygen levels to cause infection
January 17, 2019 - Cobra Biologics announces appointment of Dr Darrell Sleep as Director of Innovation
January 17, 2019 - Cellular protein that interacts with viruses appears to enable infection process of Zika virus
January 17, 2019 - Opioids Now More Deadly for Americans Than Traffic Accidents
January 17, 2019 - Women who start periods early are at greater risk of cardiovascular problems
January 17, 2019 - The brain-circuitry clash that keeps you from diving into that plate of ribs when you’re dining with royalty
January 17, 2019 - Poo transplant can successfully treat patients with ulcerative colitis
January 17, 2019 - Study suggests key role for glial cells in Parkinson’s disease
January 17, 2019 - Educational videos in clinical settings increase HPV vaccination rates among adolescents
January 17, 2019 - Better understanding of aggressive brain tumour
IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3

IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3

image_pdfDownload PDFimage_print

NEW YORK – February 14, 2018 – IRX Therapeutics, Inc. (IRX) today announced that the first patient has been dosed in an investigator-sponsored Phase 2 double-blind, randomized, placebo-controlled clinical trial of IRX-2 in women with squamous cervical intraepithelial neoplasia 3 (CIN3) or vulvar intraepithelial neoplasia 3 (VIN3). The clinical trial is being conducted at the University of Southern California (USC) Comprehensive Cancer Center in Los Angeles, California.

IRX-2 is a proprietary therapeutic containing numerous active cytokine components, which data suggests may restore and activate multiple immune cell types, including T cells, dendritic cells and natural killer cells, that are known to recognize and attack tumors.

“Current treatment options for severe cervical and vulvar intraepithelial neoplasia can cause substantial short-term morbidity as well as longer term risks to fertility, sexual function and pregnancy outcomes and so there is a great need for new treatment options,” said Lynda Roman, MD, Division of Gynecologic Oncology, USC Norris Comprehensive Cancer Care Center. “This clinical trial will study the potential of IRX-2 to restore the immune system of women diagnosed with CIN3 or VIN3 to prevent recurrent dysplasia.”

CIN 3 and VIN 3 are usually caused by certain types of human papillomavirus (HPV) and are found when a biopsy is done. If not treated, these abnormal cells may become cancerous and spread to nearby normal tissue. Overall, at least 75-80% of sexually active women will have acquired a genital HPV infection by age 50.

“We believe there is a strong mechanistic and clinical rationale for studying IRX-2 in the treatment of CIN3 and VIN3,” said Mark Leuchtenberger, President and Chief Executive Officer, IRX Therapeutics. “An earlier pilot study in 10 patients with early stage cervical cancer demonstrated that IRX-2 was well tolerated with encouraging signs of efficacy. IRX-2 is currently being studied in multiple other indications including an international Phase 2b study in squamous cell cancer of the head and neck and an investigator-sponsored Phase 1b study in breast cancer.”

About the Phase 2 CIN3 VIN3 Study

The CIN3 VIN3 study is a double blind, randomized, placebo-controlled trial. The IRX 2 regimen will include cyclophosphamide on Day 1 (three days before the start of IRX 2), IRX 2 daily for 4 days; and indomethacin, zinc with multivitamins, and a proton pump inhibitor (omeprazole) for 21 days. All treatments will be repeated at 6 weeks, for a total of two cycles. Patients will be randomized 2:1 to the treatment arm with the goal of enrolling 30 patients in the CIN3 cohort and 30 patients in the VIN3 cohort. The primary endpoint is pathological objective response at week 25. For more information, please go to clinicaltrials.gov: CIN3 VIN3 clinical trial

About IRX Therapeutics and IRX-2

IRX Therapeutics is a clinical-stage company developing novel immunotherapies focused on reducing the immune suppression that is seen in the cancer tumor micro-environment, restoring immune function, and activating a coordinated immune response against the tumor.

The lead candidate, IRX-2, is a proprietary therapeutic containing numerous active cytokine components, which data suggests may restore and activate multiple immune cell types, including T cells, dendritic cells, and natural killer cells, that are known to recognize and attack tumors. IRX-2 is a primary cell-derived biologic of produced by stimulation of human peripheral blood mononuclear cells (PBMCs) obtained from heathy donor whole blood. Data collected to date suggest that IRX-2 reduces the immune suppression that is often seen in the cancer tumor microenvironment. This immunomodulatory activity appears to occur through the restoration of immune function and activation of a coordinated immune response against the tumor.

Currently, IRX-2 is being studied in an ongoing Phase 2b clinical trial in patients with newly diagnosed Stage II, III, and IVA squamous cell carcinoma of the head and neck (SCCHN) (INSPIRE) http://inspirehnc.com/ (clinicaltrials.gov NCT02609386) as well as in a Phase 1b investigator-sponsored trial in pre-operative early stage breast cancer (ESBC) and triple negative breast cancer (TNBC) (clinicaltrials.gov NCT02950259) and a Phase 2 investigator-sponsored trial in squamous cervical intraepithelial neoplasia 3 (CIN3) or squamous vulvar intraepithelial neoplasia 3 (VIN3) (clinicaltrials.gov NCT03267680).

For more information about the Company and its clinical programs, please visit www.IRXTherapeutics.com.

Source: IRX Therapeutics, Inc.

Posted: February 2018

Tagged with:

About author

Related Articles