EXPAREL Use in Femoral Nerve Block for Total Knee Arthroplasty; NOXXON Presents Positive Results from Emapticap Pegol Nephropathy Study Print E-mail
By Staff and Wire Reports   
Friday, 04 April 2014 19:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 4, 2014.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX)
today announced additional Phase 3 data supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) to achieve a femoral nerve block in patients undergoing total knee arthroplasty. The Company previously announced results of the primary efficacy endpoint, a statistically significant reduction in cumulative pain scores over 72 hours compared to placebo (P<0.0001). Secondary endpoints presented at the 39th Annual Meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) found that a higher percentage of patients who received EXPAREL were pain-free, consumed fewer opioids and reported higher satisfaction with their pain control.

This randomized, double blind, placebo controlled study evaluated 278 patients who received either a femoral nerve block with EXPAREL or a placebo. A femoral nerve block provides pain control for the anterior (front) of the knee; in this trial there was no pain medication provided at the time of surgery for the posterior (back) of the knee, which explains the lack of a significant difference in time to first opioid rescue between the two study groups. In addition to pain scores through 72 hours, investigators also measured total opioid consumption through 72 hours, time to first opioid rescue, patient satisfaction with pain control and safety.

The key findings are summarized below:

  • A 24 percent reduction in total opioid use in the EXPAREL group (P<0.05); there was no significant difference between groups in the time to first opioid rescue
  • A greater number of patients who were “extremely satisfied” with pain control in the EXPAREL group vs. placebo group at day 7 (55 percent vs. 43 percent) and day 30 (65 percent vs. 50 percent)
  • A statistically significantly higher percentage of “pain-free” patients in the EXPAREL group (~50 percent vs. 40 percent for placebo group at 60 hours; [P<0.05])
  • Safety was comparable between the EXPAREL and placebo groups, with similar numbers of patients displaying a normal ability to do a 20-meter walk test and similar physician satisfaction with return of motor function
  • Five additional studies evaluating the use of EXPAREL in transversus abdominis plane infiltration and nerve block will also be presented at the ASRA meeting.


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NOXXON Pharma AG
announced that Phase IIa proof-of-concept data from the emapticap pegol (NOX-E36) trial in diabetic nephropathy were presented at the ISN Nexus Symposium in Bergamo, Italy earlier today.

Emapticap pegol is a Spiegelmer® that binds and neutralizes CCL2/MCP-1 (C-C Chemokine Ligand / Monocyte Chemoattractant Protein-1), a pro-inflammatory chemokine that plays an important role in diabetic kidney disease, the most common single cause of chronic kidney failure and end-stage renal disease.

The objective of this randomized, double-blind placebo-controlled multi-center international study was to evaluate the efficacy, pharmacokinetics, safety and tolerability of treatment with emapticap pegol. Seventy-five type 2 diabetic patients with albuminuria on current standard of care to control hypertension, hyperglycemia and dyslipidemia were treated for 12 weeks with twice-weekly subcutaneous emapticap pegol or placebo. This treatment period was followed by a 12 week observational period to study the long-term effect of emapticap pegol treatment on albuminuria. Importantly, the underlying standard of care mandatorily included stable renin-angiotensin system (RAS) blockade, which has been demonstrated to reduce albuminuria and to slow progression of diabetic nephropathy. Emapticap pegol was found to be safe and well tolerated with no treatment-related serious adverse events. For the primary efficacy analysis, patients with major protocol violations, on dual RAS blockade, or with concomitant hematuria and leukocyturia were excluded.

Results showed relevant, statistically significant reductions in urinary albumin excretion and improved glycemic control. Importantly, these effects were independent of hemodynamic changes and maintained after cessation of treatment, suggesting that emapticap pegol interferes with the underlying pathophysiology of diabetic nephropathy. Long-lasting effects on urinary albumin after cessation of treatment are not seen with agents currently approved to treat diabetic nephropathy (ACE inhibitors and ARBs1) or with other agents that act primarily via a hemodynamic mechanism of action such as endothelin A receptor antagonists.

Professor Dr. Hermann Haller, Director of the Department of Nephrology and Hypertension at Hannover Medical School and lead investigator of the study commented: “This Phase IIa study clearly shows that emapticap pegol is exceptionally safe and well tolerated in the target population and produces significant and clinically relevant beneficial effects on albuminuria and glycemic control after only three months of treatment. The observation that these effects are maintained even after cessation of treatment suggests that emapticap pegol interferes with the underlying pathophysiology and may be the first disease-modifying drug for this indication.”

Dr. George Bakris, Professor of Medicine and Director of the ASH Comprehensive Hypertension Center at the University of Chicago Medicine remarked: “From the data I’ve seen, I’m particularly impressed by the dissociation of emapticap pegol’s albuminuria lowering effect from hemodynamics. The fact that this beneficial effect is accompanied by an additional benefit on glycemic control is a unique feature that differentiates this drug from other compounds in development.”



Also Friday:



Amedica (Nasdaq:AMDA)
announced today that it has been invited to present at the 13th Annual Needham Healthcare Conference, being held at the Westin Grand Central Hotel on April 8th and 9th in New York City.

Amyris, Inc. (Nasdaq:AMRS)
, a leading synthetic biology innovator and renewable products company, today announced it has begun selling Biofene®, Amyris's brand of farnesene, a long-chain branched hydrocarbon, online at farnesene.net.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, has launched a genetic diagnostic test for detecting mutations in the calreticulin (CALR) gene.

Cellular Biomedicine Group, Inc. (OTCQB:CBMG)
today announced that is has begun and is enrolling patients for its Phase IIb clinical trial for human ReJoinTM adipose-derived mesenchymal precursor cell (haMPC) therapy for Knee Osteoarthritis (KOA), which tests the safety and efficacy of intra-articular injections of autologous haMPCs in order to reduce inflammation and repair damaged joint cartilage.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
today announced the pricing of an underwritten public offering of 2,857,143 shares of its common stock to institutional and other investors at a price to the public of $3.50 per share.

Endocyte, Inc. (Nasdaq:ECYT)
a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that three posters will be presented by Endocyte scientists at the 2014 Annual Meeting of the American Association for Cancer Research (AACR) to be held in San Diego, April 5-9, 2014.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced that the Camino® Flex Ventricular Catheter has received clearance from the United States Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI).

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver diseases, today announced presentations of key data at the International Liver Congress 2014, the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), being held in London, UK, at the ExCel Centre from April 9-13, 2014. Intercept will be exhibiting at booth #715 throughout the Congress.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
announced today that it will be participating in the 13th Annual Needham Healthcare Conference at the Westin Grand Central Hotel, New York, NY, on Wednesday, April 9, 2014.

Mesa Laboratories, Inc. (Nasdaq:MLAB)
today announced the acquisition of Amilabo SAS, a distributor of the Company's biological indicator (BI) products, located near Lyon, France. In this transaction, Mesa acquired all of the outstanding shares of Amilabo.

Nanosphere, Inc. (Nasdaq:NSPH)
today clarified recent transactions in Nanosphere's common stock by certain of its directors and significant stockholders in response to false and misleading reports and web site postings about those transactions, which are detailed below.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
, announced today the closing of a private placement of CAD$2,503,320 of common shares of Neptune (the "Shares") at a price of CAD$2.76 per Share, resulting in a total of 907,000 Shares being issued today (the "Private Placement").

OraSure Technologies, Inc. (Nasdaq:OSUR)
is proud to announce that Debra Fraser-Howze, the Company's Senior Vice President of Government and External Affairs, received a 2014 "Top Blacks in Healthcare" Award from BlackDoctor.org in partnership with Johns Hopkins Center for Health Disparities Solutions.

RadNet, Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 250 owned and/or operated outpatient imaging centers, today announced the expiration and final results of its previously announced cash tender offer for any and all of its outstanding $200,0000,000 aggregate principal amount of 10 3/8% Senior Notes due 2018 (the "Notes") and the related solicitation of consents to amend the indenture governing the Notes (the "Consent Solicitation").

Ventrus Biosciences, Inc. (Nasdaq:VTUS)
, a pharmaceutical company focused on developing and commercializing gastrointestinal products, today announced that, in response to a request from the company, the U.S. Food and Drug Administration (FDA) has scheduled a Type B pre-NDA meeting on Thursday, June 19, 2014 at which the company will seek guidance on its planned new drug application (NDA) for DOLIZEM (diltiazem hydrochloride cream) in anal fissures.

Xenetic Biosciences, Inc. (OTCBB:XBIO)
, a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics, today announced the appointment of Darlene Deptula-Hicks to its Board of Directors.



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