Tiziana Life Sciences Share Discussion Threads

[jpuff] 24/6/2019 07:52

Tiziana Life Sciences PLC Article on Clinical Activity of OKT3Source: RNS Non-RegulatoryTIDMTILSTiziana Life Sciences PLC24 June 2019Tiziana Life Sciences plcNewly Published Article Reporting Clinical Activity of Orally Administered OKT3, a Mouse Anti-CD3 Monoclonal Antibody, in Moderate to Severe Ulcerative Colitis Patients, Supports Tiziana's Oral Monoclonal Antibody PlatformThird party research conducted by leading U.S. institutions to be published in a peer reviewed journal Crohn's & Colitis 360 shows orally administered anti-CD3 resulted in anti-inflammatory gene expression with no serious treatment related adverse events up to a dose of 1 mg of OKT3Tiziana's platform oral monoclonal antibody (mAb) technology applicable to mAb's on the market today which are currently available only through IV, addressing an enourmous market potential.Tiziana's Foralumab is the first fully human anti-CD3 mAb which has not shown anti-drug antibody (immune reaction) in humansNew York/London, 24 June 2019 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) ("Tiziana" or the "Company"), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, notes the advance publication of a scientific article by third party researchers in the peer reviewed journal Crohn's & Colitis 360(*) titled, "Immunologic alterations associated with oral delivery of anti-CD3 (OKT3) monoclonal antibodies in patients with moderate-to-severe ulcerative colitis"(1) The published study was conducted at some of the leading medical research institutions in the world, including Harvard Medical School, Massachusetts General Hospital, and the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital. These independent findings suggest potential clinical activity and support the safety of monoclonal antibodies (mAb's) when administered orally.Tiziana's Foralumab, the only fully human anti-CD3 mAb, exhibits potency and functionality similar to OKT3, which is a mouse anti-CD3 (2). Therapeutic use of intravenously administered OKT3 and other humanized anti-CD3 mAbs is limited due to significant adverse reactions, including life threatening cytokine release syndrome. The Company is pioneering oral delivery of mAb's for the treatment of autoimmune and inflammatory diseases that is applicable to the $100 billion market of mAb's that are currently only available through IV delivery."The safe and effective oral delivery of mAb's has the potential to transform the use of biologic medications. While the scientific community has long recognized oral delivery of proteins and peptides as a challenge, we believe our propeitary platform technology is a breakthrough in oral delivery of mAb's," stated Kunwar Shailubhai, CEO & CSO of Tiziana. "We are pleased to see that some of the top researchers in the world are now validating the concept of oral administration of mAbs. Oral administration with Foralumab may have the potential to deliver superior safety and efficacy results in autoimmune and inflammatory diseases such as NASH and Crohn's disease."Foralumab is currently in a Phase 1 trial at the Harvard Medical School in healthy volunteers to study safety, tolerability and biomarkers of neurodegenerative disease through nasal delivery. An upcoming Phase 1 trial will evaluate oral Foralumab's safety, tolerability and biomarkers in Crohn's disease and NASH. A Phase 2 trial in Crohn's and NASH is expected to commence next year.The aim of this pilot study was to determine the immunologic effects and safety of orally delivered anti-CD3 antibody in patients with moderate-to-severe ulcerative colitis (UC). (1)The primary endpoints were changes in immunologic parameters and evaluation for safety. Six subjects received oral OKT3. The biologic effects of oral anti-CD3 included significantly increased proliferation in response to anti-CD3 and anti-inflammatory gene expression profile in peripheral blood mononuclear cells. No serious treatment-related adverse events occurred.Cited References:(1).Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn, W. A., Farraye, F. A., Ananthakrishnan, A. N., Yajnik, V., Gandhi, R., Nguyen, D. D., Bhan, A. K., Weiner, H. L., Korzenik, J. R., Snapper, S. B. Immunologic alterations associated with oral delivery of anti-CD3 (OKT3) monoclonal antibodies in patients with moderate-to-severe ulcerative colitis. Crohn's & Colitis 360 (2019). 183: 240-246.(2).Ogura M(1) , Deng S(1) , Preston-Hurlburt P(1) , Ogura H(1) , Shailubhai K(2) , Kuhn C(3) , Weiner HL(3) , Herold KC(4) . Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. Clin Immunol. 2017 Oct;183:240-246. doi: 10.1016/j.clim.2017.07.005. Epub 2017 Jul 21.About ForalumabForalumab (formerly NI-0401), the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in patients with Crohn's disease, with decreases in the classic side effects of cytokine release syndrome (CRS), and enhances the overall safety profile of Foralumab. In a humanized mouse model , it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus has the potential to provide therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.About OKT3Muromonab-CD3 (Orthoclone OKT3) is a murine anti-human CD3 monoclonal antibody. OKT3 was developed by Johnson and Johnson and it was the first monoclonal antibody approved by the FDA in 1985 to be administered to humans via the intravenous route for the trearment of acute, glucocorticoid-resistant rejection of allogenic renal, heart and liver transplants. However, manufacture of OKT3 was voluntarily withdrawn from the market [should say why to be balanced].About Tiziana Life SciencesTiziana 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), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.For further enquiries:Tiziana Life Sciences plc [phone]Gabriele Cerrone, Chairman and founder Stockdale Securities Limited (Broker) Andy Crossley / Antonio Bossi [phone] This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [e-mail] or visit www.rns.com.ENDNRABXGDLDSDBGCX(END) Dow Jones NewswiresJune 24, 2019 02:01 ET (06:01 GMT)

[stenick] 14/6/2019 20:48

We will see on the next news as you can’t buy if you know news is imminent.😎
Sorry to much beer and basking in the sun. Lol

[stenick] 13/6/2019 17:21

Your right there lean, but Tils does have a product or products that actually seems to work in proper clinical trials so for me there’s no comparison.

[lean5gb] 13/6/2019 17:00

It's all down to their marketing skills Sten... Something the rgt 'bods' sadly lacked.;0((((((

[stenick] 12/6/2019 16:44

That was a lean breakout. Makes me wonder why mr Cerrone keeps buying maybe it’s the fact that 80% of late stage liver cancer patients on the Milciclib trial have asked to keep taking it. As I have said before I would be interested to see what would happen if Milciclib was given to early stage cancer patients.

[abbett1] 12/6/2019 15:30

I see that Gabriele Cerrone has been topping up a few times this month.

[stenick] 11/6/2019 17:18

Lean by name lean by nature lol.

[stenick] 11/6/2019 07:57

Panetta partners buying again, a good sign when insiders are buying I was told. I hope it don’t stop here again. I think Milciclib is working rather well, we shall see soon.

[jpuff] 10/6/2019 20:22

A nice bounce today and yes I agree a breakout looking at chart :)

[lean5gb] 10/6/2019 16:29

Here we go peeps... 'breakout';0))))))))

[stenick] 05/6/2019 13:34

Pdli made a loss of 68mil to tlsa 7.5mill loss.

[ksddw2] 05/6/2019 08:54

Just came out an hour ago https://stocksbeat.com/2019/06/05/trending-stock-news/contrasting-of-tiziana-life-sciences-plc-tlsa-and-pdl-biopharma-inc-nasdaqpdli/

[jpuff] 03/6/2019 22:02

Some buying ahead of the LD Micro presentation.

[stenick] 31/5/2019 15:28

Perhaps not the AGM but at LG micro.

[abbett1] 28/5/2019 19:03

Shares been taking a beating the last 7days, doesn't look good for results

[stenick] 22/5/2019 10:35

At a guess I’d say the AGM .

[ksddw2] 22/5/2019 08:34

Any thoughts on when results due?

[stenick] 14/5/2019 17:51

That’s good then lean, I’ll be interested to see the immune responses to foralumab.

[lean5gb] 14/5/2019 13:11

It looks like the mm's think they will. ;0)))

[stenick] 14/5/2019 10:29

Data on foralumab trial tomorrow, wonder if they will post results?

[stenick] 12/5/2019 20:08

Ah but it’s the finished product.

[stenick] 11/5/2019 10:51

How about ‘as exciting as watching paint dry’!

[jpuff] 10/5/2019 16:46

Rearrange as you feel appropriate whilst biding time: Paint, grass, dry

[jpuff] 09/5/2019 17:21

Hope so! We need some action here to get this moving.

[stenick] 07/5/2019 09:23

AGM. News of takeover bid I bet imo