D-Pharm announces positive phase 2 study results of THR-18 in acute stroke patients

D-Pharm Ltd., a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders, has received the final report for its phase 2 clinical study of THR-18. THR-18 demonstrated statistically significant reductions in the incidence of intracranial hemorrhage (ICH), brain swelling (edema) and a satisfactory safety profile in stroke patients treated with tPA. Moreover, stroke recovery was improved 2-fold in patients receiving THR-18, as judged by clinical outcome measures, 30 days following stroke.

THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients. The study results were presented last month at the European Stroke Organization conference in Glasgow.

The study successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05). 

Iroko Pharma receives US patent for Zorvolex

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has received patent from the United States Patent and Trademark Office (USPTO) for the composition of matter covering Zorvolex (diclofenac) capsules 18 mg or 35 mg to treat mild to moderate acute pain and osteoarthritis pain.

The patent will be listed in the US Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book. Zorvolex which is approved by the US Food and Drug Administration (FDA) is available at pharmacies across the United States.

“We are excited to receive yet another patent on our flagship product, Zorvolex, which is another testament to our ongoing, successful collaboration with iCeutica,” said Osagie Imasogie, executive chairman of the Board and chief executive officer of Iroko Pharmaceuticals.

The term of the issued patent expires no earlier than 2030. In addition, Zorvolex has three years of regulatory exclusivity from date of product approval through FDA’s regulatory pathway. Iroko and iCeutica continue to prosecute additional patent applications for these and other products in the Iroko portfolio.