|TG Therapeutics Will Present Highlighted Data from TGR-1202; Teva Receives Favorable Court Decision Regarding Generic Celebrex Capsules|
|By Staff and Wire Reports|
|Friday, 30 May 2014 19:32|
TG Therapeutics, Inc. (Nasdaq: TGTX), an innovative, clinical-stage biopharmaceutical company today announced clinical results from its ongoing Phase I single agent study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody and from its ongoing first-in-human Phase I single agent study of TGR-1202, the Company's oral, once-daily, PI3K delta inhibitor. Data from these Phase I studies are being presented today at poster sessions during the 50^th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, with both posters selected for discussion later in the day during oral Poster Highlight sessions.
Today's poster presentations include data from 35 patients with rituximab relapsed and refractory hematologic malignancies treated with TG-1101 at doses ranging from 450 mg to 1200 mg, and from 40 patients with relapsed and refractory hematologic malignancies treated with TGR-1202 at doses ranging from 50 mg to 1800 mg QD.
Overview of the data presented on TG-1101: Safety and Tolerability -- TG-1101 (ublituximab) was well tolerated at all dose levels tested in 35 patients evaluable for safety, with Day 1 infusion related reactions (IRR) being the most frequently reported adverse event. All IRR's were Grade 1 or 2 in severity, were manageable and occurred more frequently in patients with CLL. Infusion times for the fourth and later infusions of TG-1101 averaged approximately 90 minutes.
Clinical Activity -- The overall response rate (ORR) for the Phase 1 dose escalation component and expansion cohort was 43% (30% PR, 13% CR) among the 30 rituximab relapsed/refractory patients evaluable for efficacy. TG-1101 displayed marked clinical activity as a single agent in a variety of lymphoma subtypes, reporting a 67% (4/6) response rate in patients with CLL and 44% (8/18) response rate in iNHL (22% CR, 22% PR). A breakdown of response by lymphoma subtype is below:
Lymphoma Type Pts CR PR ORR (n) n (%) n (%) n (%) CLL 6 -- 4 (67) 4 (67) iNHL 18 4 (22) 4 (22) 8 (44) aNHL 6 -- 1 (17) 1 (17) Total 30 4 (13) 9 (30) 13 (43)
Among patients with CLL, depletion of circulating lymphocytes was rapid and profound with 100% of patients achieving a peripheral response (defined as either a normalization in absolute lymphocyte count (ALC) or > 50% reduction in ALC from baseline) with a median time to peripheral response of 1 Day and a median reduction in ALC at the first response assessment in excess of 90%.
Responses have been durable, with a median progression free survival (PFS) among patients who achieved SD or better not yet reached, and a median PFS for all patients on study of 34 weeks (n=30). A number of patients in SD or better have continued on TG-1101 maintenance therapy, with improved responses observed over time with continued treatment.
Commenting on the Phase I data, Dr. Owen A. O'Connor, Director of Lymphoid Malignancies, Professor of Medicine and Experimental Therapeutics at Columbia Medical Center, New York Presbyterian Medical Center in NY, and Study Chair for the Phase I trial stated: "I am very impressed with the activity we've seen to date with ublituximab, especially as a single agent anti-CD20 monoclonal antibody in patients with heavily pre-treated disease, relapsed and in some cases refractory to prior rituximab. Ublituximab has been very well tolerated and convenient to administer to patients with a safety profile that lends itself to combination therapy."
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex® (celecoxib) 100, 200 and 400 mg capsules.
On April 17th,Teva entered into a settlement agreement with Pfizer related to Teva's generic version of Celebrex® (celecoxib) 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances.
Teva has received tentative approval from the U.S. Food and Drug Administration (FDA) for all strengths. Sales of Celebrex® were $2.2 billion in the U.S. according to IMS data as of December, 2013.
Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, today introduced its Sonix Q+ line of ultrasound systems with Quantum™ Plus Imaging Technology and a touch screen interface that can be customized to meet the specific workflow needs of physicians.
Cellectar Biosciences, Inc. (OTCQX:CLRB), announced that presentations highlighting the company's cancer and cancer stem cell-targeting delivery and retention platform of optimized phospholipid ether analogs (PLEs) and its radiotherapeutic agent, I-131-CLR1404, will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held from May 30 through June 3, 2014 in Chicago.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, announced today that Nathan Harding, chief executive officer and co-founder will present at the Jefferies 2014 Global Healthcare Conference on Thursday, June 5, 2014 at 10:00 a.m. EDT in New York, NY with a live demonstration of their bionic exoskeleton technology.
The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that it will be attending the Jefferies 2013 Global Healthcare Conference on June 3, 2014, in New York, New York.
FutureWorld (OTCQB: FWDG), a U.S. Diversified Holding Company formed to capitalize on the burgeoning global market of Industrial Hemp, announces today that they are now included on the Marijuana Index (MJX).
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the Jefferies 2014 Global Healthcare Conference.
Hemp, Inc.'s (OTC:HEMP) wholly owned subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company, Inc. (IHMMCC), is pleased to announce that it has signed a consultant agreement with View Systems, Inc. (OTCBB:VSYM), a leading Baltimore-based manufacturer and provider of integrated weapons detection systems. Per the agreement, IHMMCC will provide product distribution, professional sales and marketing services, and sales representation for the View-Scan product line to the Industrial Hemp and Medical Marijuana Industries, as well as other traditional channels of distribution.
LeMaitre Vascular, Inc. (Nasdaq:LMAT), a provider of peripheral vascular devices and implants, today announced the pricing of an underwritten public offering of 1,430,000 shares of its common stock at a price to the public of $7.00 per share.
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announced today the signing of an agreement granting BexPharm Korea Co. Ltd. exclusive rights to market and distribute NexoBrid® in South Korea for the treatment of severe burns upon receipt of regulatory approval.
MRI Interventions, Inc. (OTCQB:MRIC), a commercial stage medical technology company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, today announced that it will be exhibiting its ClearPoint® Neuro Intervention System at the 2014 American Society for Stereotactic and Functional Neurosurgery (ASSFN) Biennial Meeting to be held June 1-3 in Washington, D.C.
Myriad Genetics, Inc. (Nasdaq:MYGN), a global leader in molecular diagnostics, announced the presentation of new data at the American Society of Clinical Oncology (ASCO) meeting this week that supports the clinical efficacy of its BRACAnalysis CDx™ and HRD™ tests in predicting platinum based therapy response for breast cancer patients.
Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that Kenneth L. Waggoner, CEO and President, will present at the fourth annual LD MICRO Invitational Conference at the Luxe Hotel in Los Angeles, California on Wednesday, June 4th, 2014 at 4:00pm PDT.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that Health Canada has granted regulatory approval to ELELYSO™ (taliglucerase alfa for injection) for the long-term enzyme replacement therapy for both adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.
SANUWAVE Health, Inc. (OTCQB:SNWV) announced the Company will present at the 4th Annual Micro-Cap Invitational Conference hosted by LD Micro on Wednesday, June 4, at the Luxe Hotel in Los Angeles, California.
Swisher Hygiene Inc. (Nasdaq:SWSH), a leading service provider of essential hygiene and sanitizing solutions, announced today that the one-for-ten reverse stock split of Swisher's issued and outstanding shares of common stock will be effective at 12:01 a.m. on Tuesday, June 3, 2014.