Full Press Release Details
Tiziana Life Sciences
Tiziana Life Sciences
Acquires a Nanoparticle-Based Formulation Technology for Controlled Delivery of Actinomycin D for Treatment of Myelodysplastic
syndrome and Acute Myeloid Leukemia
Nanoparticle Actinomycin formulation minimizes
toxicity and enhances tolerability by slow release of drug to control Cmax in blood
This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014.
- April 24, 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology
company focused on innovative therapeutics for inflammatory, autoimmune and infectious diseases, announced today that it pursuant
to an asset purchase agreement it has acquired all of the intellectual property relating to a nanoparticle-based formulation of
Actinomycin D (Act D; a.k.a. Dactinomycin), from Rasna Therapeutics, Inc. ("Rasna") to expand its pipeline for a consideration
of an initial $120,000 upfront payment and milestone payments of up to an additional aggregate $630,000.
This formulation technology was invented by
Dr. Kunwar Shailubhai when he was previously an executive officer at Rasna, which he remains a director.
D, an antibiotic drug, was approved initially for infectious diseases in the United States in 1964. Subsequently, this antibiotic
was shown to exhibit anti-cancer activity in 1974 (1). Since then the drug has been used to treat various types of cancer,
including Wilms tumor, rhabdomyosarcoma, Ewing's sarcoma, trophoblastic neoplasm, and testicular cancer. The
drug is on the World Health Organization's List of Essential Medicines
as the most effective medicines needed in a health system (2). Falini et al., reported in New England Journal of Medicine
that intravenous administration of Act D could be used for treatment of patients with Acute Myeloid Leukemia (AML) carrying NPM1
gene mutation (3). Recent studies have also suggested that Act D, being a potent inhibitor of RNA synthesis, may have potential
for treatment of COVID-19 patients (4). Currently, the drug is intravenously (IV) administered, which produces severe toxicities
possibly due to excessive Cmax in blood during the first couple of hours after administration.
The nanoparticle-based
Act D (NP-ACT D) is formulated such that the release of Act D is slow and Cmax in blood may be pre-adjusted to a desired level.
In pharmacokinetics (PK) and safety studies in rats, free Act D or an equivalent dose of NP-Act D were intravenously administered
side-by-side to compare PK, tolerability, and toxicity. Results from these animal studies indicated that the PK of NP-Act D was
slow, and sustained for over 32 hours, whereas the PK in blood within an equivalent dose of free Act D activity was rapid. Importantly,
another study comparing side-by-side free Act D with an equivalent dose of NP-Act D, showed 0% mortality in rats dosed with NP-Act
D for up to 13 days. By contrast, mortality in rats dosed with free Act D began on 6th day, reaching >90% mortality on 13th
day of the study. These results demonstrate that PK of IV administered NP-Act D is slow and sustained for extended period and it
is relatively well-tolerated with minimal toxicities. However, safety and tolerability of NP-Act D needs to be evaluated in healthy
volunteers prior to clinical studies.
to note that the Company has not, at the current time, conducted any clinical or pre-clinical research into the use of NP-ACT D
as a treatment for COVID-19 but is basing its assessment for potential on research involving NP-ACT D with other strains of coronavirus.
Broad-spectrum antibiotics that have been
deemed safe-in-man' through testing in early phase clinical trials have been touted as good drug repurposing candidates
for treatment of emerging infectious diseases. Actinomycin D, an inhibitor of RNA-dependent RNA polymerase, is a potent antibiotic
with therapeutic utilities in infectious diseases and cancer. As intravenous administration of Actinomycin D is known to produce
severe toxicities, its therapeutic utility has been limited. The nanoparticle-based Actinomycin D (NP-ACT D) is formulated to
control and slow release of Act D such that the Cmax in blood can be adjusted to a desired level. In animal studies, NP-Act D
was found to produce minimal toxicities and it was found to safe and well-tolerated.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology
company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In
addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3
monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune
and inflammatory diseases, such as nonalcoholic steatohepatitis ("NASH"), ulcerative colitis, multiple sclerosis, type-1
diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response
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Forward-Looking Statements
Certain statements made in this announcement
are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's
current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as anticipates,'
expects,' intends,' plans,' believes,' 'seeks,' estimates,'
and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance
and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control,
are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking
statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking
statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made
in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any
obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or
unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
The person who arranged for the release of this information was Dr Kunwar Shailubhai, the Company's Chief Executive and Chief
Tiziana Life Sciences plc
Cairn Financial Advisers LLP (Nominated adviser)
Shore Capital (Broker)