focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.

Less Ads, More Data, More Tools Register for FREE

Pin to quick picksTILS.L Regulatory News (TILS)

  • There is currently no data for TILS

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

Licenses milciclib from Nerviano Medical Sciences

20 Jan 2015 07:00

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 £2.14 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 £1. 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
 
 
MSCEAEFEAFXSEEF
Date   Source Headline
30th Jul 20083:25 pmRNSSubstantial Shareholding
30th Jul 20089:51 amRNSUpdate on ADRs - Replacement
29th Jul 20081:47 pmRNSUpdate on ADRs
14th Jul 20082:30 pmRNSADRs listed on International
11th Jul 200810:51 amRNSSubstantial Shareholding
9th Jul 20084:16 pmRNSBoard Changes
26th Jun 200810:00 amRNSNew Study published
19th Jun 20085:26 pmRNSSubstantial Shareholding
17th Jun 200812:03 pmRNSResults of Zolpidem study
10th Jun 200810:12 amRNSSales Update
3rd Jun 200812:44 pmRNSResult of AGM
3rd Jun 200811:00 amRNSAGM Statement
16th May 20082:44 pmRNSShareholding
14th May 200811:23 amRNSHealthcare Conference
30th Apr 20089:13 amRNSTotal Voting Rights
28th Apr 200812:28 pmRNSAnnual Report and Accounts
25th Apr 20081:35 pmRNSScientific Review published
21st Apr 20085:43 pmRNSShareholding
17th Apr 20087:00 amRNSIssue of Equity
7th Apr 200812:14 pmRNSSubstantial Shareholding
2nd Apr 20089:00 amRNSPreliminary Results
1st Apr 20083:33 pmRNSHolding(s) in Company
31st Mar 20089:10 amRNSTotal Voting Rights
31st Mar 20088:00 amRNSResults of Study
28th Mar 20089:00 amRNSFurther Placing
26th Mar 20089:00 amRNSNew Broker and Placing
25th Mar 20083:12 pmRNSEU Import & Sale Approved
18th Mar 20089:00 amRNSChange of Registered Address
10th Mar 20087:00 amRNSEU Distributor Appointed
12th Feb 20085:59 pmRNSShareholding
11th Feb 20087:00 amRNSColostrinin Study Results
31st Jan 20083:00 pmRNSShareholding
2nd Jan 20084:53 pmRNSMajor Interest in Shares
10th Dec 20074:30 pmRNSResearch Update
6th Dec 20075:43 pmRNSSignificant Shareholding
5th Dec 20071:13 pmRNSHolding(s) in Company
5th Dec 20071:08 pmRNSHolding(s) in Company
4th Dec 200711:39 amRNSHolding(s) in Company
30th Nov 200711:30 amRNSTotal Voting Rights
22nd Nov 200711:34 amRNSHolding(s) in Company
21st Nov 20072:01 pmRNSDirector/PDMR Shareholding
20th Nov 20074:45 pmRNSResult of EGM
20th Nov 200712:08 pmRNSEGM Statement
14th Nov 20079:02 amRNSHolding(s) in Company
9th Nov 20074:06 pmRNSHolding(s) in Company
8th Nov 20075:22 pmRNSHolding(s) in Company
2nd Nov 20073:24 pmRNSHolding(s) in Company
31st Oct 20079:00 amRNSZolpidem on BBC 1 documentary
29th Oct 20077:01 amRNSHolding(s) in Company
26th Oct 20073:58 pmRNSCapital Consolidation, EGM

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.