Drugs / Milciclib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | non-small cell lung carcinoma | 2022-12-15 | “today announced the Investigational New Drug (IND) application filing for milciclib in combination with gemcitabine for non-small cell lung cancer (NSCLC).” tizianalifesciences.com ↗ “On December 15, 2022, Tiziana filed an IND with the FDA pertaining to a Phase 2 study of milciclib in combination with gemcitabine for NSCLC indication.” tizianalifesciences.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01300468 | Apr 2006 → May 2009 | cancer | Nerviano Medical Sciences | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT05651269 | Mar 2023 → Dec 2024 | non-small cell lung carcinoma | Tiziana Life Sciences LTD | Unknown | No outcome recorded |
| Phase 2 | NCT03109886 | Jul 2017 → May 2019 | hepatocellular carcinoma | Tiziana Life Sciences LTD | Completed | Met primary |
| Phase 2 | NCT01301391 | Feb 2011 → May 2017 | thymoma type B3 | Tiziana Life Sciences LTD | Terminated | No outcome recorded |
| Phase 2 | NCT01011439 | Feb 2010 → May 2017 | thymic carcinoma | Tiziana Life Sciences LTD | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-01-04 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Announces IND filed for Phase 2 Study of Milciclib in Combination with Gemcitabine for Non-Small Cell Lung Cancer tizianalifesciences.com ↗
NEW 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). |
| 2020-05-14 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Online Publication of Two Abstracts at ASCO Reporting Clinical Activity and Safety of Milciclib in Patients with Advanced Hepatocellular Carcinoma tizianalifesciences.com ↗
The first abstract reports Phase 2a clinical data with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma (HCC) patients, for which it met the primary endpoint that oral treatment with Milciclib was well tolerated with manageable toxicities and no recorded drug-related deaths. |
| 2020-05-14 | Tiziana Life Sciences LTD | Results ASCO Abstract 298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients tizianalifesciences.com ↗
Milciclib, a pan cyclin dependent kinase inhibitor, exhibited anti-cancer activity in refractory solid malignancy patients. |
| 2019-09-04 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma tizianalifesciences.com ↗
Tiziana Life Sciences plc (NASDAQ: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, today announced additional positive Phase 2a clinical data exhibiting impressive clinical activity of Milciclib monotherapy in patients with advanced Sorafenib-resistant or -intolerant patients with unresectable or metastatic hepatocellular carcinoma (HCC). |
| 2019-07-22 | Tiziana Life Sciences LTD | Results Tiziana Reports Phase 2a Clinical Data with Milciclib Monotherapy in Sorafenib-refractory or -intolerant patients with unresectable or metastatic Hepatocellular Carcinoma tizianalifesciences.com ↗ |
| 2019-04-24 | Tiziana Life Sciences LTD | Results Tiziana Reports Encouraging Interim Clinical Data from an Ongoing Phase 2a Trial with milciclib in Advanced Liver Cancer Patients tizianalifesciences.com ↗
The IDMC reviewed safety data from patients as of 26 February 2019, and concluded that the administration of milciclib to patients with advanced hepatocellular carcinoma (“HCC”) was not associated with unexpected signs or signals of toxicity. |
| 2017-04-28 | Tiziana Life Sciences LTD | Regulatory Video: Eyeing phase II clinical trial in HCC patients with milciclib tizianalifesciences.com ↗
Dr. Kunwar Shailubhai talks to Tip TV about Tiziana receiving approval to start Phase IIa trials to test its leading compound milciclib, a CDK inhibitor as a treatment for hepatocellular carcinoma (HCC). |
All press releases naming this drug 11 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Milciclib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01301391 ↗ |
| Known as | Milciclib Maleate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01011439 ↗ |
| Known as | PHA 848125 | ChEMBL registry synonym — accepted as the source's own label CHEMBL564829 ↗ |
| Known as | PHA-848125AC | “Milciclib Maleate (PHA-848125AC)” NCT01011439 ↗ |
| Action | Inhibit | “Nerve growth factor receptor Trk-A inhibitor” CHEMBL564829 ↗3“Cyclin-dependent kinase 2 inhibitor” CHEMBL564829 ↗ “Cyclin-dependent kinase 4 inhibitor” CHEMBL564829 ↗ “Cyclin-dependent kinase 1 inhibitor” CHEMBL564829 ↗ |
| Modality | Small molecule | — CHEMBL564829 ↗ |
| Route | Oral | “Oral PHA-848125AC” NCT01011439 ↗ |
| Target | CDK1 | “Cyclin-dependent kinase 1 inhibitor” CHEMBL564829 ↗ |
| Target | CDK2 | “Cyclin-dependent kinase 2 inhibitor” CHEMBL564829 ↗ |
| Target | CDK4 | “Cyclin-dependent kinase 4 inhibitor” CHEMBL564829 ↗ |
| Target | NTRK1 | “Nerve growth factor receptor Trk-A inhibitor” CHEMBL564829 ↗ |