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Jeff Ramson
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Founder and CEO of ProActive Capital Resources Group (PACRG), LLC, - over 25 years trading and investing. I employ technical analysis combined with discretionary analysis of global events and trends. I am equally comfortable from either long or short side of the markets. Owner of... More
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  • TGTX TG Therapeutics Expands Upon A Promising Anti-Cancer Pipeline  0 comments
    Aug 16, 2012 10:36 AM

    ProActive Capital Resources Group has received compensation from TG Therapeutics, to provide research and investor relations coverage for a period of time.

    TG Therapeutics (NASDAQ:TGTX) is focused on the acquisition, development and commercialization of innovative treatments for cancer and other unmet medical needs with a summary of the Company's pipeline outlined below.

    1.) Ublituximab is a CD20-targeted anti-cancer monoclonal antibody that will be evaluated in a Phase I / II clinical trial expected to begin this quarter with final results expected late next year in up to 36 patients in the Phase I dose-escalation portion of the trial followed by up to 77 patients in the Phase 2 portion in patients with B-cell lymphomas that are relapsed or refractory to standard treatments such as RITUXAN.

    RITUXAN is the leading anti-CD20 product currently on the market with global sales in 2011 of about $7 billion and Ublituximab has been bio-engineered to specifically enhance the effects of RITUXAN for potentially additive anti-cancer effects for B-cell related disorders such as Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). In addition, anti-CD20treatments have demonstrated effectiveness for auto-immune conditions such as Rheumatoid Arthritis (NYSE:RA) and lupus in addition to the neurological disorder multiple sclerosis.

    Ublituximab has been evaluated in a two-part Phase 1clinical trial in France and was well tolerated with no major safety concerns along with encouraging signs of effectiveness and clinical benefit in patients with advanced forms of CLL. Ublituximab is manufactured by the Company's partner, LFB Biotechnologies, with ongoing plans to develop a new manufacturing method utilizing transgenic animal vectors through subsidiary GTC Bio therapeutics.

    2.) AST-726 is a nasally delivered formulation of hydroxocobalamin for the treatment of vitamin B12 deficiency. $TGTX has global rights toAST-726, which has demonstrated equivalence to the widely used intramuscular(NYSE:IM) injected formulation that is typically given once-monthly for B12deficiency. The Company expects to announce its development plans for AST-726within the next 6-12 months.

    3.) Earlier today, $TGTX announced an exclusive global (ex-India)development and commercialization agreement with Rhizen Pharmaceuticals forTGR-1202 (previously RP5264), which is classified as a highly specific, orally available PI3K (phosphoinositide-3-kinase) delta inhibitor for the treatment of blood-based cancers and autoimmune disorders based on preclinical results. The Company expects to file an Investigational New Drug (NYSE:IND) application with FDA during 4Q12 seeking clearance to begin clinical trials. Rhizen is eligible to receive over $250 million in potential development and sales-based milestone payments plus royalties on nets sales of the drug.

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