TIDMTILS
RNS Number : 5759C
Tiziana Life Science PLC
20 January 2015
Tiziana Life Sciences plc
Tiziana Life Sciences plc ("Tiziana", AIM: TILS) today announces
that it has entered into an agreement with Nerviano Medical
Sciences Group. The full text of the joint announcement
follows:
Tiziana Life Sciences licenses milciclib from Nerviano Medical
Sciences
Second candidate added to clinical pipeline
CDK inhibitor has potential in hepatocellular, breast and thymic
cancers
London, 20 January 2015 - Tiziana Life Sciences plc ("Tiziana",
"the Company", AIM: TILS), the clinical stage biotechnology company
focused on targeted drugs to treat diseases in oncology and
immunology, is pleased to announce that it has exclusively licensed
milciclib from Nerviano Medical Sciences Group ("Nerviano"), an
Italian company dedicated to the discovery and development of
breakthrough treatments for cancer.
Milciclib blocks the action of specific enzymes called
cyclin-dependent kinases ("CDKs"), which are involved in cell
division as well as a number of other protein kinases. Milciclib is
currently in phase II clinical trials for thymic carcinoma in
patients previously treated with chemotherapy. Milciclib has
demonstrated that it is well tolerated in over 263 patients in
phase I and II clinical trials and has been granted orphan
designation by the European Commission and by the U.S. Food and
Drug Administration ("FDA") for the treatment of malignant thymoma
/ thymic epithelial tumours. Subject to successful completion of
the ongoing phase II trials, Tiziana is committed to initiate a
phase III study in this indication in 2016.
Nerviano has shown in preclinical studies that milciclib has
potential in other cancer indications, in particular liver cancer
and breast cancer, for which potential biomarkers of response have
been identified and which will support the clinical development in
these indications planned to start in 2015. Tiziana plans to
immediately enrol patients into a new phase II trial in
hepatocellular carcinoma using a protocol already prepared by
Nerviano, and will explore the potential for an additional phase II
trial in breast cancer.
Commenting on the licensing agreement, Gabriele Cerrone,
Chairman and Founder of Tiziana, said: "Nerviano is a high value
partner for Tiziana with immense scientific heritage in oncology
that started with the success of the anthracyclines and is now
continuing with innovative targeted therapies. The addition of
milciclib, with its robust safety profile, significantly
strengthens Tiziana's pipeline and offers us the potential to
provide a new treatment for liver cancer, an additional approach
for treating breast cancer and continuing phase II trials in thymic
carcinoma. Milciclib broadens our breast cancer franchise and,
together with foralumab, which we licensed in late 2014, we now
have two clinical assets with three different clinical
indications."
Under the terms of the licensing agreement with Nerviano,
Tiziana will make an upfront cash payment of US$3.5 million for the
license to Nerviano. Tiziana will also pay to Nerviano specified
milestone payments of up to US$35 million and a royalty on net
sales of any products containing milciclib.
In addition, Tiziana will pay GBP2.14 million to be satisfied by
the issue of 4,233,616 new ordinary shares (the "Shares") in the
Company to Nerviano (at a price of 50.5p per share which is the
closing price of the Company's ordinary shares on 16 January 2015,
the last business day prior to execution of the licensing
agreement). The Shares are subject to restrictions dependent on the
success of the clinical development programmes. In the event that
there is an unsuccessful phase II trial in liver cancer or breast
cancer, or a phase II trial has not been completed by 19 January
2020, the Company has the right to buy back the Shares for a
consideration of GBP1. Nerviano has agreed that the Shares will be
subject to a lock-in arrangement until successful completion of a
phase II trial and for a period of 12 months thereafter. Nerviano
will be able to exercise voting rights relating to the Shares
whilst they are locked in.
Application has been made to the London Stock Exchange for the
Shares to be admitted to trading on AIM which is expected to occur
on or around 26 January 2015. Following the issue of the Shares,
the Company will have 88,905,928 ordinary shares in issue. The
Shares will rank pari passu with the existing ordinary shares of
the Company. Exercise of the Company's buy back rights is subject
to shareholder approval under the UK Companies Act and is expected
to be obtained at the Company's annual general meeting in 2015.
Under the licensing agreement, Tiziana will be responsible for
future development costs for milciclib in thymoma / thymic
epithelial tumours and in any additional indications, including
hepatocellular carcinoma and breast cancer. Tiziana will entrust
the manufacturing and the performance of clinical studies for
milciclib up to completion of phase II to Nerviano.
"We are delighted to enter into this agreement with Tiziana Life
Sciences, as a further recognition of our research approach and the
value of our pipeline," said Luciano Baielli, CEO of Nerviano. "As
a group, Nerviano is, in fact, actively building alliances to
strengthen the development of our projects and offer new
therapeutic options for physicians and patients' unmet needs. Our
goal is to lead innovation in oncology and I am confident that our
recognised expertise as a provider of integrated R&D
capabilities will lead to a further significant new hope for cancer
patients."
Contacts:
Tiziana Life Sciences plc
Philip Boyd, CFO +44 (0)20 7493 2853
Cairn Financial Advisers LLP (Nominated
adviser)
Liam Murray / Avi Robinson +44 (0)20 7148 7900
Beaufort Securities Limited (Broker)
Saif Janjua +44 (0)20 7382 8300
FTI Consulting
Simon Conway / Rob Winder / Natalie
Garland-Collins +44 (0)20 3727 1000
Nerviano Medical Sciences Group
Communication
Chiara Lattuada +39 (0)331 58 1368
Barabino & Partners
Marco Catalani +39 (0)2 7202 3535
About milciclib
Milciclib is a spectrum selective multi-kinase inhibitor of
cyclin-dependent kinases initially identified in a CDK2 inhibitor
project, as a potent inhibitor of the CDK2/Cyclin A complex. It
possesses an unusual kinase inhibitory profile, being active also
against other selected members of receptors tyrosine kinases, src
family and splicing kinases.
Milciclib is currently in phase II as single agent in thymic
carcinoma ("Phase II Study Of Oral PHA-848125AC In Patients With
Thymic Carcinoma Previously Treated With Chemotherapy".
NCT01011439, http://clinicaltrials.gov). Orphan designation was
granted by the European Commission and by the FDA to milciclib for
the treatment of malignant thymoma / thymic epithelial tumours.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that
focuses on the discovery and development of novel molecules that
treat human disease in oncology and immunology.
The Company has a phase II asset, foralumab, the only fully
human engineered anti-human CD3 antibody in clinical development.
Foralumab has potential application in a wide range of autoimmune
and inflammatory diseases, such as multiple sclerosis, type-1
diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and
rheumatoid arthritis, where modulation of a T-cell response is
desirable.
Tiziana Life Sciences' research team has discovered that Bcl-3
has a prominent role in the metastasis of mammary cancers, and has
elucidated the mechanism of Bcl-3 action to be a regulator of
cancer cell motility. Tiziana has also determined that Bcl-3
inhibition suppresses cell motility in triple-negative,
HER-2-positive PR- and ER-positive breast cancer sub-types,
suggesting that Bcl-3 may be a master regulator of this metastatic
property not only in aggressive breast cancers, but across the
clinical spectrum of breast disease.
About Nerviano Medical Sciences Group
Nerviano is the largest company in Italy, and among the most
important in Europe, in the field of pharmaceutical research and
development in oncology. Nerviano is already able to boast
important cooperation or licensing agreements with pharmaceutical
and biotech companies, as well as with the world of academia.
On 31 December 2011 the Lombardy Region became the major
shareholder of Nerviano, through the FRRB (Regional Foundation for
Biomedical Research).
This information is provided by RNS
The company news service from the London Stock Exchange
END
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