Full Press Release Details
Life Sciences Announces IND filed for Phase 2 Study of Milciclib in Combination with Gemcitabine for Non-Small Cell
YORK, January 4, 2023 -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"),
a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced the Investigational
New Drug (IND) application filing for milciclib in combination with gemcitabine for non-small cell lung cancer (NSCLC).
Phase 2 IND filing, which was achieved with minimal additional resource deployment, enhances the asset value and
Tiziana's optionality for milciclib," commented Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer
of Tiziana. "Milciclib previously showed encouraging results in several cancer clinical studies - both as a monotherapy and in
combination with gemcitabine. We believe that there could be an important role for a pan-CDK inhibitor in the oncologist's
toolbox. At the same time, we are highly focused on advancing our leading CNS-focused programs with intranasal foralumab, which
continues to generate encouraging data in our expanded access trial of secondary progressive multiple sclerosis."
is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomyosin receptor kinases and Src family kinases
controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety in 316 patients with advanced solid cancers
in Phase 1 and 2 studies and shown indications of efficacy. In two completed Phase 2 thymic cancer trials, milciclib successfully increased
overall survival and met both primary and secondary endpoints.
Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery
technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal, oral and inhalation approaches in development
have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's
two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated
a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of
immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
Malik, Business Development and Investor Relations Manager
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
LifeSci Advisors, LLC