| Name | Title | Contact Details |
|---|---|---|
Chulani Karunatilake |
Chief Technology Officer | Profile |
RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via our proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP®) therapy platform. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. Our lead product candidate, RenovoGem, is a combination of gemcitabine and our patented delivery system regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). Targeted therapy via RenovoTAMP platform safely and without transmission to non-targeted areas, is our primary focus. RenovoRx`s patent portfolio currently includes seven issued US patents and one European patent for ourtechnology with several additional patents pending in the US, Europe, and Asia. After demonstrating a median survival of 27.9 months in Phase 1/2 clinical trials vs. 12-15 months reported in historical studies for this patient population, RenovoRx secured two separate Orphan Drug Designations from the FDA for intra-arterial gemcitabine: pancreatic cancer and bile duct cancer (cholangiocarcinoma). This therapy is being further studied in the currently enrolling Phase 3 TIGeR-PaC clinical trial in pancreatic cancer and has a primary endpoint of overall survival and several secondary endpoints, including quality of life. The Phase 3 TIGeR-PaC clinical trial is enrolling unresectable locally advanced pancreatic cancer patients (LAPC) in the United States.
ALLERGY ASSOC is a Onalaska, WI-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our partners. K&L was established in the US in 1995, and has grown rapidly worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.
Cortendo AB is a global biopharmaceutical company founded in 1996, incorporated in Sweden, and based in the United States. Cortendo recognizes the urgent need to make new medicines available for people with orphan diseases, and the Company is committed to delivering therapies that make a difference. An orphan disease is one for which the pharmaceutical industry has not worked to make new medicines. It may be a rare disease (in the U.S. this is defined as a disease that affects fewer than 200,000 people) or a disease such as tuberculosis, cholera, typhoid or malaria that is not often diagnosed in developed countries but remains common in countries that are still developing. Cortendo’s initial strategic goal is to be the global leader in finding, developing and making medicines for people with orphan endocrine diseases, with its most advanced program in Cushing’s syndrome. Cortendo research led to the development of COR-003 (levoketoconazole) which is currently being studied in the Phase 3 global SONICS trial for the treatment of endogenous Cushing’s syndrome. COR-003 has received orphan designation from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Cortendo is building the capabilities and resources to independently develop and commercialize its orphan assets in key global markets and to partner non-strategic product opportunities, such as BioPancreate-2001 for Type 1 and Type 2 diabetes. The company also intends to leverage its commercial expertise by working with partners to acquire, develop, and commercialize late-stage or commercial assets in a select few orphan disease focus areas.
PharmaForm is a leading specialty contract development and manufacturing organization focusing on oral and transmucosal dosage forms. Founded in 1996, PharmaForm has built a reputation for delivering novel and innovative solutions to challenging problems