LX4211 Enhances Effects of DPP-4 Inhibition in Patients with Type 2 Diabetes; FDA has accepted Arena Resubmitted Lorcaserin Print E-mail
By Staff and Wire Reports   
Tuesday, 10 January 2012 20:11
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 10, 2012.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today top-line results from the first clinical study testing the combined effects of LX4211, a novel sodium glucose transporter 1 and 2 (SGLT1 and SGLT2) inhibitor, with the dipeptidyl peptidase 4 (DPP-4) inhibitor, sitagliptin (Januvia®), one of the most widely prescribed diabetes drugs.

"The results of this study are important given that combination therapy is the mainstay of current diabetes treatment," said Dr. Pablo Lapuerta , senior vice president of clinical development and chief medical officer at Lexicon.  "Alone, LX4211 produces rapid improvement in postprandial blood glucose by delaying intestinal glucose absorption and increasing urinary glucose excretion.  When combined, the two agents produce enhanced benefits on blood glucose, insulin, GLP-1 and PYY relative to sitagliptin alone, suggesting these agents work together and could provide additional benefits for patients with type 2 diabetes."

Results from the study in 18 patients with type 2 diabetes showed that single doses of LX4211, a dual inhibitor of SGLT1 and SGLT2, in combination with sitagliptin, produced lower blood glucose levels after meals (postprandial) as compared to treatment with sitagliptin alone (p=0.012).  This enhanced glycemic control was associated with an elevation of active glucagon-like peptide-1 (GLP-1) over treatment with either LX4211 or sitagliptin alone (p<0.001).  Consistent with LX4211 monotherapy effects, LX4211 increased total GLP-1 (p<0.001) and PYY (p=0.014) with reduced insulin levels (p=0.025) when dosed with sitagliptin, all three effects not observed with sitagliptin alone.  Active and total GLP-1 are important mediators of blood sugar and metabolic control and PYY has been shown to suppress appetite.  GLP-1 and PYY are normally released in response to a meal.  All treatment regimens were well tolerated.

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Shares of Arena Pharmaceuticals (NASDAQ:ARNA) +0.57% shot up 11% early Tuesday on news the FDA has accepted its resubmitted application for the diet-drug lorcaserin.

The agency is expected to decide whether to approve the product by June 27. The FDA had declined to approve lorcaserin until it received more information about its safety profile. The product is being co-developed with Japan's Esai Inc.


Also Tuesday:


Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, announced today significant momentum in global adoption of its CyberKnife® Robotic Radiosurgery System and TomoTherapy® System, solidifying the company's footprint in the large and growing radiation oncology market.

Anika Therapeutics, Inc. (Nasdaq: ANIK) a leader in products for tissue protection, healing and repair, based on hyaluronic acid (“HA”) technology, today announced that Chief Financial Officer Kevin Quinlan will present at the Eighth Annual Noble Financial Equity Conference in Hollywood, Florida.

BioLife Solutions Inc. (OTCBB: BLFS), a leading developer, manufacturer, and marketer of proprietary hypothermic storage and cryopreservation freeze media for cells and tissues, today announced preliminary record revenue for the fourth quarter and full calendar year 2011.

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that Dr. Samuel Lynch, president and CEO, will provide an update of corporate activities at the 30th Annual J.P. Morgan Healthcare Conference on Thursday, January 12th at 10:00 a.m. Pacific Standard Time.

CONMED Corporation (NASDAQ: CNMD)
announced today that it expects to report fourth quarter 2011 financial results before the market opens on Wednesday, February 15, 2012, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.

CryoPort, Inc. (OTCBB: CYRX) was mentioned in a 60 MINUTES story Sunday night as the “highest medical standard” for safely and securely transporting cryogenically frozen materials.

Fluidigm Corporation (NASDAQ:FLDM) today announced that President and Chief Executive Officer Gajus Worthington will present at the 30th Annual J.P. Morgan Healthcare Conference on Thursday, January 12, 2012, at the Westin St. Francis Hotel, San Francisco, beginning at 1:00 p.m. Pacific Standard Time.

iBio, Inc. (NYSE AMEX: IBIO) announced today the pricing of an underwritten public offering of 15,385,000 units at $0.65 per unit for gross proceeds of approximately $10 million.

IGEN Networks Corporation (IGEN:OTCBB) is pleased to announce the signing of a world-wide distribution agreement with Star Solutions International  Inc.,  ("Star Solutions") , a leading edge All-IP wireless broadband infrastructure supplier.

Illumina (Nasdaq:ILMN) today introduced the HiSeq® 2500, a next-generation sequencing system that will enable researchers and clinicians to sequence an entire genome in approximately 24 hours, “Genome in a Day”.

Intellicell Biosciences, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC)
; (“Intellicell”) or the (“Company”), Intellicell has licensed its proprietary, patent, pending technology for the manufacture of stromal vascular fraction from adipose tissue to Cell-Innovations, Pty Limited a company headquartered in Sydney, Australia.

InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that CEO Frank Reynolds is scheduled to appear on KTXL-TV’s FOX40 Live on Wednesday, January 11th during their 8:00 AM (PST) newscast.

Kedem Pharmaceuticals Inc. (OTCBB: KDMP), a specialty pharmaceutical company with focus on sublingual drug delivery is pleased to announce that has completed all the dosages production of X-Excite, the Company's lead therapeutic drug for erectile dysfunction.

MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has received the certification for the Company's proprietary CollaFix™ Surgical Mesh CD.

MMRGlobal, Inc. (OTCBB: MMRF), a leading provider of Personal Health Records (PHR), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that its MyMedicalRecords.com PHR will be part of the ng Connect Program's service concept, TeleConsult, storing patients' medical history, including wirelessly transmitted biometric data for use by patients and their medical team.

NanoLogix Inc. (PINK SHEETS: NNLX), an innovator in the accelerated detection, identification and antibiotic sensitivity determination of live bacteria announces that has instructed a third-party to prepare a total of six applications for submittal to the US FDA.

Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio) today announced that it will be making a presentation today at 10:45 am (PST) in the Windsor Room of the Sir Francis Drake Hotel as part of the fifth annual OneMedForum SF 2012 Conference for emerging biotech companies held over 3 days this week in conjunction with the JP Morgan Annual Healthcare Conference.

Oramed Pharmaceuticals Inc. (OTCBB:ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has filed a provisional patent application with the United States Patent and Trademark Office for a combination therapy of its lead compound, ORMD-0801 in combination with its oral exenatide formulation, ORMD-0901.

QIAGEN (NASDAQ: QGEN) today announced the regulatory approval of its therascreen® EGFR Mutation Detection Kit RGQ in Japan.

ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it has opened a new facility to meet the growing capacity needs of one of its largest customers, Eli Lilly and Company ("Lilly").

TelVue® Corporation (OTCQB: TEVE) (PINKSHEETS: TEVE), a leader in IP Television Broadcasting and Internet Video Streaming, is pleased to announce the addition to its Sales and Marketing team of UChannel™ Founder and CNN veteran Donna Liu, in the newly-created position of Director, New Media.



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