News Headlines

  1. ORYZON Receives Approval To Start ALICE: A Phase IIa Clinical Trial In AML With Iadademstat (ORY-1001)

    Oryzon Genomics (ISIN Code: ES0167733015, ORY), 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 elderly Acute Myeloid Leukemia (AML) patients not eligible for intensive chemotherapy.

  2. Foamix Announces Positive Topline Results From Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam For Moderate-To-Severe Acne

    Foamix Pharmaceuticals Ltd., a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced the topline results of its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne.

  3. ContraFect Completes Enrollment In Phase 2 Clinical Trial Evaluating CF-301 (Exebacase) In Patients With Staphylococcus Aureus Bacteremia

    ContraFect Corporation (Nasdaq:CFRX), a clinical-stage biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced that it has completed enrollment in the Phase 2 clinical trial evaluating its first-in-class lysin, CF-301, as a potential treatment for Staphylococcus aureus (Staph aureus) bacteremia including endocarditis.

  4. Fibrocell Announces FDA Fast Track Designation Of FCX-013 For Treatment Of Moderate To Severe Localized Scleroderma

    Fibrocell Science, Inc. (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma—a chronic, debilitating genetic skin disorder with no FDA approved therapies.

  5. Tyme Exceeds Enrollment Expectations For The Phase II Trial Of SM-88 In Pancreatic Cancer

    Tyme Technologies, Inc. (NASDAQ:TYME), today announced that the number of currently consented or randomized subjects has exceeded the enrollment target for the Stage 1 dose selection portion of the Company’s Phase II trial in metastatic pancreatic cancer ahead of the trial’s anticipated timeline.

  6. ProQR Announces Positive Interim Results From Phase 1/2 Clinical Trial Of QR-110 In LCA10 Patients, And Plans To Start A Phase 2/3 Pivotal Trial

    ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced results from a planned interim analysis of its Phase 1/2 trial of QR-110 in patients with Leber’s congenital amaurosis 10 (LCA10) due to the p.Cys998X mutation in the CEP290 gene. LCA10 typically leads to childhood blindness and has no available treatment options.

  7. Inovio Doses 1st Subject In Phase 1/2 Clinical Trial For Vaccine Against Deadly MERS Infection

    Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today announced the dosing of the first subject with its vaccine to prevent infection from the deadly MERS virus (Middle East Respiratory Syndrome) in a Phase 1/2a study to evaluate INO-4700 (or GLS-5300).

  8. Celsion Announces Enrollment Completion For Pivotal Phase III OPTIMA Study Of ThermoDox® In Primary Liver Cancer

    Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that it has reached its enrollment objective of 550 patients in the Company's pivotal, Phase III OPTIMA Study, a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.

  9. WCG Clinical Services Division Partners With Inspire To Improve Patient Recruitment In Clinical Trials

    The WIRB-Copernicus Group’s (WCG) Clinical Services Division has partnered with Inspire, the largest online community of patients and caregivers, to make clinical research more accessible to all patients, especially those suffering from rare and genetic-based diseases.

  10. Pieris Pharmaceuticals Announces Dosing Of First Patient In Phase I Combination Trial For PRS-343 Plus Anti-PD-L1 Immunotherapy

    Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, announced today that it has dosed the first patient in the Company’s Phase 1 combination clinical trial of PRS-343, its lead proprietary immuno-oncology drug candidate targeting HER2 and 4-1BB, plus atezolizumab (Tecentriq®), an approved PD-L1 inhibitor.