Tiziana Lifesciences Announces Online Publication of Two Abstracts at the American Society of Clinical Oncology (ASCO) Report...
May 14 2020 - 10:00AM
Tiziana Life Sciences plc (NASDAQ: TLSA, AIM: TILS) (“Tiziana” or
the “Company”), a biotechnology company focused on innovative
therapeutics for oncology, inflammation and infectious diseases,
today announces the online publication of two abstracts on clinical
studies with Milciclib, a small molecule pan-inhibitor of cyclin
dependent kinases (CDKs) in the proceedings of the virtual annual
meeting of American Society of Clinical Oncology 2020 (ASCO20).
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. The
second abstract reports preliminary clinical data from an ongoing
investigator-originated trial with a combination of orally
administered Milciclib and Regorafenib in liver transplant patients
with recurrent HCC. Thus far, the study has shown mean AFP levels
(a common tumor biomarker) reduced by approximately 20% within one
month of treatment.
MAJOR
HIGHLIGHTSAbstract #298561: Phase 2a
Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase
Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant
Hepatocellular Carcinoma Patients. First Author: Erica Villa, MD.,
et al.
- Phase 2a multi-centered clinical evaluation of Milciclib (100
mg once daily; 4 days on/3 days off for 4 weeks; defining each
cycle) for 6-month in 28 evaluable out of 31 enrolled patients
in Italy, Greece and Israel.
- The trial successfully met the primary endpoint that oral
treatment with Milciclib was well tolerated with manageable
toxicities and no recorded drug related deaths.
- The secondary endpoints for clinical activity assessment were
based on the independent radiological review using the modified
Response Evaluation Criteria in Solid Tumors (mRECIST)
- Positive demonstrated clinical activity included:
- 50% (14 out of 28) evaluable patients completed 6-month
duration of the trial.
- 64% (9 out of 14) patients requested and were approved by their
respective ethical committees to continue the treatment.
- Both median time to progression (TTP) and progression free
survival (PFS) were 5.9 months (95% Confidence Interval ("CI")
1.5-6.7 months) out of the 6-months duration of the trial.
- Approximately 57% of evaluable patients showed 'Stable Disease'
(SD; met at least once in an 8-week interval) and 3.6% patients
showed 'Partial Response' (PR).
- Approximately 61% of patients showed 'Clinical Benefit Rate'
defined as CBR=CR+PR+SD (with CR representing Complete
Remission).
- Five patients on compassionate use continued the treatment for
a total of 9, 9, 11, 13 and 16 months, respectively. Two patients
continuing the treatment have reached 16 months.
“Advance cases of patients with HCC have limited
therapeutic options because of the poor safety and tolerability of
existing drugs. Thus, a newer drug, preferentially with a different
mechanism of action, such as Milciclib is a necessary medical
need,” stated Prof. Angelo Sangiovanni, M.D. principal investigator
of the study and site investigator at Fondazione IRCCS Cà Granda
Ospedale Maggiore Policlinico, Milan, Italy. “In this context,
safety, and tolerability of oral treatment with Milciclib is
remarkable. Results from the phase 2a clinical study demonstrating
clinical activity in these advance cases of HCC are notable. The
fact that many of the treated patients continued with the
treatment, even after completing 6 months duration of the study, is
particularly very impressive.”
Abstract #307309: Safety and
Clinical Activity of Combination Treatment with Regorafenib and
Milciclib in Liver Transplant Patients with Hepatocellular
Carcinoma Recurrence. First Author: Alessandro Pivetti. MD., et
al.
- Seven patients enrolled to date in this ongoing study
- Combination treatment of Milciclib and Regorafenib was well
tolerated with manageable toxicities
- Mean AFP levels reduced by 20% within one month of
treatment
- Patients treated for longer duration had 50% reduction in AFP
levels
- Currently, patients enrolled in the study are in 2 to 10 months
of treatment period
"Our center has been involved with clinical
evaluation of several drug candidates in advanced HCC patients and
both of the above-mentioned studies were conducted at our site. The
oral treatment with Milciclib is not only very well tolerated but
it also showed clinical activity. Most of these patients with
advance cases of HCC are exhibiting stabilization of disease and
have continued the treatment under a compassionate use program,
which in my opinion is very impressive,” added Prof. Erica
Villa, M.D., site Investigator at the Policlinico di Modena,
Modena, Italy. “Moreover, the positive clinical activity and
impressive safety and tolerability of Milciclib in combination with
Regorafenib in liver transplant patients with recurrent HCC is
certainly noteworthy. Thus, clinical data from these two studies
are very encouraging and warrant continued development of
Milciclib, either as monotherapy or combination therapy."
About Milciclib (TZLS-201)Milciclib (PHA-848125AC)
is a small molecule inhibitor of several cyclin dependent kinases
such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine
kinases that play crucial roles in progression of the cell cycle
from G1 to S phase. Overexpression of CDKs and other
downstream signalling pathways that regulate cell cycles have been
frequently found to be associated with development of resistance
towards chemotherapies. In a phase I study, oral treatment with
Milciclib was found to be well-tolerated and the drug showed
promising clinical responses in patients with advanced solid
malignancies such as in NSCLC, pancreatic and colon cancer, thymic
carcinoma and thymoma. About Tiziana Life
SciencesTiziana Life Sciences plc is a dual listed
(NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that
focuses on the discovery and development of novel molecules to
treat human diseases in oncology inflammation and infectious
diseases. In addition to milciclib, the Company will be shortly
initiating phase 2 studies with orally administered foralumab for
Crohn’s Disease and nasally administered Foralumab for progressive
multiple sclerosis. Foralumab is the only fully human anti-CD3
monoclonal antibody (mAb) in clinical development in the world.
This phase II compound has potential application in a wide range of
autoimmune and inflammatory diseases, such as Crohn’s Disease
multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel
disease (IBD), psoriasis and rheumatoid arthritis, where modulation
of a T-cell response is desirable. The company is accelerating
development of anti-Interleukin 6 receptor (IL6R) mAb, a fully
human monoclonal antibody for treatment of IL6-induced
inflammation, especially for treatment of COVID-19
patients.About ASCOThe American Society of
Clinical Oncology (ASCO) was established in 1964 with the sole
purpose of improving the care of people with cancer. Membership
currently stands at 40,000 physicians and scientists. ASCO is one
of the premiere organizations for the advancement of cancer
treatments and the annual ASCO meeting is an important forum for
discussion of new cancer therapies and treatments. For more
information go to http://www.tizianalifesciences.comTHE PERSON
WHO ARRANGED FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR
SHAILUBHAI, THE COMPANY'S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC
OFFICER.
Contacts: |
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Tiziana Life Sciences plc |
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United Kingdom: |
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Gabriele Cerrone, Chairman and founder |
+44 (0)20 7495 2379 |
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Cairn Financial Advisers LLP (Nominated adviser) |
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Liam Murray / Jo Turner |
+44 (0)20 7213 0883 |
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Shore Capital (Broker) |
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Antonio Bossi / Fiona Conroy |
+44 (0)20 7601 6125 |
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United States: |
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Investors |
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CORE IR |
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ir@coreir.com |
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Media |
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Jules Abraham |
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CORE IR |
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(917) 885-7378 |
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julesa@coreir.com |
|
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