Breaking News
April 19, 2018 - Novel biomarker can distinguish malignant lung nodules
April 19, 2018 - Study reports promising novel approach to treat therapy resistant pediatric brain tumors
April 19, 2018 - One-Hour Plasma Glucose Useful Predictor of Diabetic Retinopathy
April 19, 2018 - Hydroxychloroquine no more effective than placebo for relieving osteoarthritis hand pain
April 19, 2018 - Transplanted livers have a protective effect and reduce potential for organ rejection
April 19, 2018 - Researchers develop new method to study activity of inflammatory cells
April 19, 2018 - Researchers discover highly antibiotic resistant superbugs in Gulf States
April 19, 2018 - U.S. Women Less Likely Than Men to Get Statins After Heart Attack
April 19, 2018 - Atypical brain development observed in preschoolers with ADHD symptoms
April 19, 2018 - SC Johnson releases annual Sustainability Report
April 19, 2018 - Positive attitudes about aging reduce risk of dementia in older adults
April 19, 2018 - Environmental pollutants found to worsen rheumatoid arthritis
April 19, 2018 - UT Southwestern scientists discover protein linked to metastatic breast cancer
April 19, 2018 - Study highlights need for further evidence to improve symptom management in end of life care
April 19, 2018 - Detecting diminished dopamine-firing cells inside brain could reveal earliest signs of Alzheimer’s
April 19, 2018 - Uniqsis offers high-power LED light unit for scalable flow photochemistry reactions
April 19, 2018 - Case study shows how intravascular ultrasound imaging helps detect acute aortic syndrome
April 19, 2018 - Research reveals new mechanism by which HIV evades the immune system
April 19, 2018 - Nanodisc-delivered cancer treatment helps eliminate tumors
April 19, 2018 - Functional connectivity MRI could help detect brain disorders and diseases
April 19, 2018 - Finding better way to quantify neuropathy symptoms and treatment efficacy
April 19, 2018 - Study examines effectiveness of caregiver education about sickle cell trait
April 19, 2018 - High-resolution images of tumor vasculature using new technology
April 19, 2018 - Lack of sleep may be linked to risk factor for Alzheimer’s disease
April 19, 2018 - Study finds neurotransmitter may play a role in alcohol relapse, addiction
April 19, 2018 - Researchers build molecular networks of calcific aortic valve disease
April 19, 2018 - Researchers develop highly specific apoptosis assay for pharmacodynamic analyses of tumor specimens
April 19, 2018 - Scientists decipher mechanism of chemotherapy induced female infertility
April 19, 2018 - New insight may allow researchers to design drugs that improve immune responses to vaccines
April 19, 2018 - FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
April 19, 2018 - Researchers uncover origin of virus-fighting plasma B cells
April 19, 2018 - Study finds no evidence of lower intelligence in young children who had anesthesia
April 19, 2018 - Baboons break out of research facility briefly
April 19, 2018 - Study shows how deployment time increases risk of suicide attempt in soldiers
April 19, 2018 - Specific odors from malaria infected individuals attract more mosquitoes
April 19, 2018 - FDA Alert: Rhino 69 Extreme 50000 by AMA Wholesale: Recall
April 19, 2018 - Top HIV cure research team refutes major recent results on how to identify HIV persistence
April 19, 2018 - Experts propose new solutions to increase benefit, affordability of targeted cancer medicines
April 19, 2018 - Deficiency of innate immune adaptor TRIF shortens survival time of ALS mice
April 19, 2018 - New machine learning method offers better way to detect heart disease
April 19, 2018 - CNIO researchers determine structure of protein complex related to cell survival
April 19, 2018 - Faith-based diabetes support program launched by UTSA research team
April 19, 2018 - Volumetric Laser Endomicroscopy Helps ID Barrett’s Regions
April 19, 2018 - Engineered cartilage template to heal broken bones
April 19, 2018 - New computational framework accurately predicts drug-drug and drug-food interactions
April 18, 2018 - Some human cancers may be result of evolutionary accidents, research finds
April 18, 2018 - Higher levels of education linked to lower dementia risk in older African Americans
April 18, 2018 - Smoking Puts Blacks at Higher Risk for Heart Failure
April 18, 2018 - Physiotherapist contributes to guidelines for knee cartilage treatment
April 18, 2018 - Researchers use ‘top-down proteomics’ strategy to get new insights into cancer
April 18, 2018 - Physician assistants less likely to accurately diagnose early stage skin cancers
April 18, 2018 - New faster, streamlined method for bowel cancer detection and treatment
April 18, 2018 - Researchers identify new Listeria species in Costa Rica
April 18, 2018 - Novel interactive diagram shows many facets of mild traumatic brain injury
April 18, 2018 - Short sleep linked to obesity in children and adolescents
April 18, 2018 - When weight loss helps with sleep
April 18, 2018 - New mathematical model can predict efficiency of microbiome therapies
April 18, 2018 - People with high LDL cholesterol levels likely to get greater benefits from statins
April 18, 2018 - Listening to music enhances effect of anti-hypertensive drugs
April 18, 2018 - New method could help treat severe epilepsy in the future
April 18, 2018 - Study reveals increased risks for Alzheimer’s, suicide among youth in polluted cities
April 18, 2018 - Obese patients more likely to develop rapid and irregular heart rate
April 18, 2018 - Study may change global guidelines for managing children with uncomplicated fever
April 18, 2018 - Researchers find letter we’ve seen millions of times, yet can’t write
April 18, 2018 - Roswell Park researchers identify driver of cancer-promoting metabolic changes
April 18, 2018 - Study shows connection between early life stress, depression and sleep disturbances
April 18, 2018 - New tool developed to protect women from HIV infection
April 18, 2018 - Tradeshow Talks with HealthSapiens
April 18, 2018 - NYC mice carry deadly bacteria and viruses
April 18, 2018 - FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia
April 18, 2018 - Doctors curbing first-time prescriptions for opioids
April 18, 2018 - Scientists analyze nanostructure of chicken eggshells
April 18, 2018 - Study finds muscle complications among active young adults with Type 1 diabetes
April 18, 2018 - Young children should be priority for snail fever treatment
April 18, 2018 - One class of diabetes drug not associated with reduced risk of death
April 18, 2018 - Breakthrough microscope revolutionizes live cell imaging of stem cells
April 18, 2018 - Study on arthritis prevalence and trends reveals unexpected findings
April 18, 2018 - Low-Vision Rehab Improves Several Elements of Visual Function
April 18, 2018 - Babies who look like their father at birth are healthier one year later: study
April 18, 2018 - New drug for migraine in the pipeline
Trovagene Announces First Patient Successfully Completes Cycle 1 of Treatment with PCM-075 in Combination with Low Dose Cytarabine (LDAC) in AML Trial

Trovagene Announces First Patient Successfully Completes Cycle 1 of Treatment with PCM-075 in Combination with Low Dose Cytarabine (LDAC) in AML Trial

image_pdfDownload PDFimage_print

SAN DIEGO, March 5, 2018 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, developing targeted cancer therapeutics, today announced that the initial patient successfully completed the first cycle 1 of treatment in its Phase 1b/2 multicenter trial of PCM-075 in combination with low-dose cytarabine (LDAC) in patients with Acute Myeloid Leukemia (AML). The patient tolerated the combination well and correlative analyses of blood samples, taken at specified time points, also indicated activity on leukemic blood cells.

A significant decrease in the percentage of blood leukemic cells was observed within 24 hours of administering PCM-075 + LDAC. By day 15, within the treatment cycle, the greatest effect was observed with blood leukemic cells showing a decrease from greater than 40% to less than 5%. Additionally, the same tumor DNA mutations (ASXL1 and SRSF2) were detected in the bone marrow and blood, indicating consistency across samples and validity of the analyses. Both DNA mutations appeared to quantitatively track with the decrease in blood leukemic cells.

“Our first patient on PCM-075 appears to be tolerating the drug regimen well and the observed decrease of blood leukemic cells during the treatment cycle is encouraging,” said Alex Spira, MD, PhD, FACP, Director of The Virginia Cancer Specialists Research Institute.

“We are pleased to see our AML trial off to such a great start,” said Bill Welch, Chief Executive Officer of Trovagene. “With six clinical trial sites open and actively screening and enrolling patients, including MD Anderson Cancer Center, Virginia Cancer Specialists, Kansas University Cancer Center, Yale Cancer Center, Virginia Piper Cancer Institute and UCLA, we anticipate increasing enrollment in the coming weeks and look forward to sharing additional data as it becomes available.”

The Phase 1b/2 trial is a multi-center, open-label trial exploring the safety and efficacy of PCM-075 in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory. This trial is being led by Hematologist Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

About PCM-075

PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple hematologic and solid tumor cancers. Studies have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in Acute Myeloid Leukemia (AML) where response rates up to 31% were observed when used in conjunction with a standard therapy for AML (low-dose cytarabine-LDAC) versus treatment with LDAC alone with a 13.3% response rate. A Phase 1 open-label, dose escalation safety study of PCM-075 has been completed in patients with advanced metastatic solid tumor cancers, and published in Investigational New Drugs. Trovagene is initiating a Phase 1b/2 clinical trial with PCM-075 in AML that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03303339. PCM-075 has been granted Orphan Drug Designation by the FDA for the treatment of patients with AML.

PCM-075 only targets PLK1 isoform (not PLK2 or PLK3), is oral, has a 24-hour drug half-life with reversible on-target hematologic toxicities. Trovagene believes that targeting only PLK1 with reversible on-target activity and an improved dose/scheduling protocol can significantly improve on the long-term outcome observed in previous studies with a PLK inhibitor in AML.

PCM-075 has demonstrated synergy in preclinical studies with over 10 chemotherapeutic and target agents used in hematologic and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK-1 inhibitor, PCM-075, with other compounds has the potential for improved clinical efficacy in Acute Myeloid Leukemia (AML), Castration-Resistant Prostate Cancer (CRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC) and Adrenocortical Carcinoma (ACC).

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a hematologic malignancy in which myeloid lineage cells of the bone marrow cease to differentiate appropriately, resulting in a marked increase in the number of circulating immature blast cells. As a consequence, the counts of mature red blood cells, platelets, and normal white blood cells decline, causing fatigue, shortness of breath, bleeding, and increased susceptibility to infection. The Surveillance, Epidemiology and End Results (SEER) program estimates the annual incidence rate of AML in the United States to be approximately 21,000 cases in 2017. Rates of new AML cases have been rising an average of 3.1% each year over the last 10 years. The median age of AML diagnosis is 68 years of age, and approximately 45% of new diagnoses are among patients age 70 years or older.

About Trovagene, Inc.

Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit https://www.trovagene.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2017, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

SOURCE Trovagene, Inc.

Posted: March 2018

Tagged with:

About author

Related Articles