|Astex Announces IND Candidate: ASTX727 a Potential Best-in-Class Oral Hypomethylator; QIAGEN Receives FDA Approval for therascreen®|
|By Staff and Wire Reports|
|Friday, 12 July 2013 18:51|
Astex Pharmaceuticals, Inc. (Nasdaq: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced its plan to submit an Investigational New Drug or IND application to the Food and Drug Administration (FDA) for ASTX727, a novel oral hypomethylating agent (HMA) in the fourth quarter of this year.
ASTX727 is intended as a fixed dose oral combination product consisting of decitabine and E7727, a novel cytidine deaminase inhibitor (CDAi) licensed from Eisai Inc. ASTX727 allows for an efficient oral delivery of decitabine at low doses. Relevant animal studies revealed that the product can result in therapeutic exposures of decitabine at low doses. The profile of E7727 is expected to result in low inter-patient variability across doses of decitabine with little or no gastrointestinal safety issues. Later this year, preclinical data on ASTX727 will be submitted for presentation at a scientific meeting.
"We are pleased to announce that ASTX727, in the late pre-clinical stage of development, becomes the third product in our epigenetic franchise that began with DACOGEN® (decitabine) for Injection. This franchise includes SGI-110, expected to enter Phase III clinical trials in 2014," commented James S.J. Manuso, Ph.D., Astex Pharmaceuticals chief executive officer and chairman. "The role of HMAs, in a wide range of therapeutic indications, is just beginning to be understood. ASTX727, potentially a best-in-class oral HMA, will be an important addition to our portfolio of medicines in clinical development."
QIAGEN N.V. (NASDAQ: QGEN) announced it has received approval by the U.S. Food and Drug Administration (FDA) to market the therascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim's new targeted therapy, GILOTRIF™ (afatinib), for treatment of metastatic NSCLC in patients whose tumors have certain EGFR gene mutations. More than 200,000 new lung cancer cases are diagnosed every year in the United States, with NSCLC accounting for approximately 85% of cases, leading to an estimated 160,000 deaths.
The therascreen EGFR test enables doctors to identify EGFR mutation-positive patients eligible for treatment with GILOTRIF™ (afatinib). The FDA approval of the therascreen EGFR test marks a further milestone in the global expansion of QIAGEN's Personalized Healthcare franchise - and adds a third FDA-approved or cleared diagnostic kit to run on QIAGEN's efficient Rotor-Gene Q MDx. Approximately 120,000 metastatic NSCLC patients each year in the U.S. could benefit from testing for EGFR mutations, a total potential testing market of about $35 million, according to QIAGEN estimates.
"We are very pleased to receive approval to market our therascreen EGFR test in the United States, a successful outcome from our collaboration with Boehringer Ingelheim. QIAGEN's companion diagnostics are transforming patient care and extending lives around the world by providing personalized genomic information to guide treatment decisions," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. "The U.S. launch of the therascreen EGFR test adds to our growing menu of FDA-approved diagnostics running on the Rotor-Gene Q MDx, a real-time PCR platform in our revolutionary QIAsymphony family. Following the 2012 launch of our therascreen KRAS RGQ PCR Kit (therascreen KRAS test) in colorectal cancer, U.S. laboratories already have adopted this test for more than half of the KRAS testing volume."
Amarin Corporation plc (Nasdaq:AMRN) today announced that it had completed its previously announced underwritten public offering of 21,700,000 American Depositary Shares ("ADSs").
Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it plans to issue its second-quarter 2013 financial results after the close of the market on Wednesday, July 31, 2013.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced today that it has filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a 1-for-8 reverse stock split of its common stock, effective as of 5:00PM Eastern Time today.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the District Court of Mannheim, Germany, today found that Medtronic infringes Edwards' Spenser patent for transcatheter heart valve technology.
Generex Biotechnology Corporation (OTCBB: GNBT) today announced particulars of the conference call it will be hosting featuring members of the Antigen Express, Inc. Scientific Advisory Board.
LeMaitre Vascular, Inc. (Nasdaq:LMAT), announced today that it will release its second quarter 2013 financial results on July 30, 2013, after the market close.
Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced today that it has entered into a definitive arrangement agreement with Mitsubishi Tanabe Pharma Corporation ("Mitsubishi Tanabe Pharma" or "MTPC") whereby MTPC will acquire all of the issued and outstanding common shares ("Shares") of Medicago, other than the Shares currently held by Philip Morris Investments B.V. ("PMI") an affiliate of Philip Morris International Inc. and MTPC, for $1.16 in cash per Share (the "Purchase Price"). Upon completion of the transaction, Medicago will be jointly owned by MTPC (60%) and PMI (40%).
Dick Govatski, CEO of Net Medical Xpress Solutions, Inc. (OTCQB: NMXS), a leader in the telemedicine market, said today he sees opportunity in the growth of telemedicine in Africa and specifically Nigeria.
NeoStem, Inc. (NYSE MKT:NBS), a leader in the emerging cell therapy market, announced that it is effecting a 1-for-10 reverse stock split of its common stock which will be effective for trading purposes as of the commencement of trading on July 16, 2013.
Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today announced that it will release second quarter 2013 financial results on Tuesday, July 30, 2013 after the close of the U.S. financial markets.
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received approval by the U.S. Food and Drug Administration (FDA) to market the therascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim's new targeted therapy, GILOTRIF™ (afatinib), for treatment of metastatic NSCLC in patients whose tumors have certain EGFR gene mutations.
RXi Pharmaceuticals Corporation (OTCQX: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced positive results from their second placebo-controlled Phase 1 study with RXI‑109, an sd-rxRNA® compound that targets Connective Tissue Growth Factor (CTGF), and is being developed for the treatment of abnormal dermal scars such as hypertrophic scars and keloids in conjunction with scar revision surgery.
Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH) announced today its second quarter 2013 sales and earnings conference call will be broadcast live over the Internet on Thursday, July 25, 2013, at 8:00 a.m. Eastern Time.
Zynex, Inc. (OTCQB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced today the Company's updated financial outlook for the remainder of 2013.