Breaking News
March 22, 2019 - Less invasive valve replacement can be safe and effective alternative for healthier patients
March 22, 2019 - Aphasia research reveals new, complex interactions between thought and language
March 22, 2019 - Artificial neural networks can predict how different areas in the brain respond to words
March 22, 2019 - Age-related changes to gut microbiome have adverse impact on vascular health, study shows
March 22, 2019 - Isolated seniors chat online to prevent cognitive decline
March 22, 2019 - Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
March 22, 2019 - Eruptive xanthomatosis
March 22, 2019 - Cause of vascular disease in kidney failure reversed in animal model
March 22, 2019 - Researchers discover possible new therapeutic strategy for pancreatic cancer
March 22, 2019 - Ebola spreads to second largest city in DRC
March 22, 2019 - Perivascular spaces contribute to worse cognitive health in older adults
March 22, 2019 - Adolescent daily users more likely to obtain electronic cigarettes from commercial sources
March 22, 2019 - FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
March 22, 2019 - Diabetes myths and facts: MedlinePlus Medical Encyclopedia
March 22, 2019 - TGen and ABL pursue global rollout of advanced TB test
March 22, 2019 - Traffic light labels influence people to choose healthier and more sustainable meals
March 22, 2019 - Alzheimer’s patients using antiepileptic drugs have twice the risk of pneumonia, study shows
March 22, 2019 - Skin diseases may be more prevalent than previously thought
March 22, 2019 - Overall rates of death from breast cancer are falling across the EU
March 22, 2019 - Novel plasmid could hold key to control of mosquito-borne illness
March 22, 2019 - Female Emergency Physicians Paid Less Than Males
March 22, 2019 - Estimated average glucose (eAG): MedlinePlus Medical Encyclopedia
March 22, 2019 - Experimental drug could be new option for type 2 diabetes
March 22, 2019 - Five Things To Know About The Electronic Health Records Mess
March 22, 2019 - TMJ disorders could be treated with tissue-engineered implants after successful animal study
March 22, 2019 - Team-based approach is key to successful care of pregnant women with heart failure
March 22, 2019 - Study identifies gene variant associated with accelerated cellular aging
March 21, 2019 - Salk scientists show how background noise from neurons can interrupt focused attention
March 21, 2019 - New class of drugs could help treat patients diagnosed with ovarian cancer
March 21, 2019 - Tecentriq Approved for Small Cell Lung Cancer
March 21, 2019 - Adipocyte glucocorticoid receptors play a role in developing steroid diabetes
March 21, 2019 - Climate change can affect nutrient content of crops, harming human health
March 21, 2019 - Podcast: KHN’s ‘What The Health’ Surprise! Fixing Surprise Medical Bills Is Harder Than it Looks
March 21, 2019 - Chemistry researchers patent new method for making anti-leukemia compounds
March 21, 2019 - UIC scientists identify hidden proteins in bacteria
March 21, 2019 - New Australian drug trial achieves remarkable results in patients with acute myeloid leukemia
March 21, 2019 - Females live longer when they have help raising offspring
March 21, 2019 - How did orthodontists sell orthodontics?
March 21, 2019 - In the Spotlight: From dietitian to physician assistant student
March 21, 2019 - The CRISPR Revolution: What You Need to Know
March 21, 2019 - FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records
March 21, 2019 - Combined glucocorticoid and antioxidant therapy could benefit premature babies
March 21, 2019 - Low levels of certain eye proteins could serve as predictor for Alzheimer’s
March 21, 2019 - Post-traumatic holocaust survivors transmit negative views on aging to offspring
March 21, 2019 - City of Hope receives $7.5 million in grant awards to study cutaneous T cell lymphoma
March 21, 2019 - New video game-led training device helps stroke survivors regain arm mobility
March 21, 2019 - Compounds in coffee could slow prostate cancer growth
March 21, 2019 - New mobile DNA element in Wolbachia may contribute to improved disease control strategies
March 21, 2019 - Phase 2 Clinical Trial of Bermekimab Shows Potential New Standard of Care for Treatment of Hidradenitis Suppurativa, Including Significant Pain Reduction without Antibiotics
March 21, 2019 - More than one-third of patients risk major bleeding by doubling up on blood thinners
March 21, 2019 - A skeptical look at popular diets: Thumbs up for Mediterranean
March 21, 2019 - PTSD After Cardiac Arrest Predicts More Heart Trouble
March 21, 2019 - Role of immunological imprinting in elicitation of new antibodies
March 21, 2019 - Breast cancer relapse predictor tool may soon be a reality
March 21, 2019 - New computer program developed by TGen lights up cancer-causing genetic mutations
March 21, 2019 - FDA warns two breast implant makers for failure to comply with post-approval study requirements
March 21, 2019 - Butler Hospital receives COBRE grant to enhance research on neuropsychiatric illnesses
March 21, 2019 - Majority of osteoporosis clinical practice guidelines ignore patients’ voices
March 21, 2019 - Generic messages don’t help patients to lose weight
March 21, 2019 - Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
March 21, 2019 - Two-drug combos using popular calcium channel blocker show superiority in lowering BP
March 21, 2019 - Q BioMed and Mannin Research collaborate with McMaster University to develop GDF15 biomarker glaucoma diagnostic kit
March 21, 2019 - First-in-human pilot study shows positive results for ‘bacteria-phobic’ catheter
March 21, 2019 - Itamar Medical launches next-generation WatchPAT system for home sleep apnea testing
March 21, 2019 - Study estimates health and economic impacts of healthy food prescriptions
March 21, 2019 - Detecting fungal disease in crops with multispectral imaging system
March 21, 2019 - MIT announces creation of the Alana Down Syndrome Center
March 21, 2019 - Next-generation LVAD device clinically superior, safer for heart failure patients
March 21, 2019 - Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
March 21, 2019 - Mutations in noncoding genes could play big role in regulating cancer, study finds
March 21, 2019 - A medical student’s thoughts on Match Day
March 21, 2019 - Are eggs good or bad for you?
March 21, 2019 - New analysis reveals precision oncology insights for colorectal cancer
March 21, 2019 - Pollutants appear to weaken immune system and increase pathogen virulence
March 21, 2019 - Researchers develop and validate scale for rating severity of mononucleosis
March 21, 2019 - Scientists identify generation of key immune response in mice on introducing solid food
March 21, 2019 - New nanomaterial could restore internal structure of damaged bones
March 21, 2019 - Selective destruction of prostate tumor as effective as complete prostate removal
March 21, 2019 - 2011 to 2015 Saw Increase in Psychiatric ED Visits for Youth
March 21, 2019 - Tapeworm drug targets common vulnerability in tumor cells
Oryzon Receives Approval to Start CLEPSIDRA: a Phase IIa Clinical Trial in Small Cell Lung Cancer with Iadademstat (ORY-1001)

Oryzon Receives Approval to Start CLEPSIDRA: a Phase IIa Clinical Trial in Small Cell Lung Cancer with Iadademstat (ORY-1001)

image_pdfDownload PDFimage_print

MADRID, Spain and CAMBRIDGE, Mass., Oct. 17, 2018 (GLOBE NEWSWIRE) — Oryzon Genomics S.A. (ISIN Code: ES0167733015, ORY), (“Oryzon”), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, has announced today that it has received approval of a Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct a Phase IIa clinical study with Iadademstat (ORY-1001) in Small Cell Lung Cancer (SCLC) patients in first relapse.

The study, named CLEPSIDRA (“A Combination trial of LSD1 and Etop-Platinum in Small Cell Lung Cancer in Biomarker-ID Relapsed pAtients”), will be conducted in several Spanish hospitals. CLEPSIDRA is a single-arm, open-label study of Iadademstat in combination with the standard of care treatment platinum-etoposide in patients with relapsed, extensive-stage disease SCLC but still eligible for a second round of platinum based treatment. The study is divided into two parts. The first part is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of Iadademstat in combination with platinum-etoposide based chemotherapy and to assess safety and tolerability. The extension part is to evaluate the clinical effect, including the tumor response, time to response, duration of response, time to progression, progression-free survival and overall survival. Approximately 36 patients will be recruited in this study. The patients to be included will be first screened for tumor biomarkers identified by the scientists of the company.

Iadademstat is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (See Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A first Phase I/IIa clinical trial with Iadademstat in refractory and relapsed acute leukemia patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity including a CRi (manuscript in preparation). Oryzon has recently received approval to start a Phase IIa clinical trial of Iadademstat in combination with azacitidine in acute myeloid leukemia (ALICE study). Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as SCLC. SCLC represents 15% of lung neoplasms and is an aggressive malignant tumor with very limited treatment options. Recently, it has also been published that the inhibition of LSD1 improves the antitumor response of the immune system and, in melanoma models, eliminates resistance to therapy with PDL-1 antibodies, a stellar agent of the Immuno-Oncology field already approved for use in various types of tumors (see Sheng et al., Cell 2018 Jun 18. pii: S0092-8674 (18) 30715-3.doi: 10.1016 / j.cell.2018.05.052).

Roger Bullock, Oryzon’s Chief Medical Officer, commented: “CLEPSIDRA is our second Phase IIa clinical combo trial with Iadademstat. In preclinical studies, the combination of Iadademstat with Platinum etoposide has shown promising results. Particularly, we know that the responses to the treatment with Iadademstat of cancer cells extracted from some SCLC patients in first relapse are very intense, for this reason CLEPSIDRA incorporates also a biomarker strategy identified by the scientists of the company.”

About Oryzon

Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon is publicly traded on the Spanish Automated Quotation System (Continuous Market) that includes the Madrid, Barcelona, Bilbao and Valencia Stock Exchanges. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com.

FORWARD-LOOKING STATEMENTS

This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.

Source: Oryzon Genomics S.A.

Posted: October 2018

About author

Related Articles