Boston Scientific Announces Results from Promus Premier; Salix's Budesonide Foam Shows Significant Results Print E-mail
By Staff and Wire Reports   
Wednesday, 22 May 2013 20:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 22, 2013.

Boston Scientific Corporation (NYSE: BSX)
reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease.  Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, and two-year follow-up data from the EVOLVE Trial comparing the safety and effectiveness of the SYNERGY Everolimus-Eluting Bioabsorbable Polymer-Coated Platinum Chromium Coronary Stent System to the PROMUS Element™ Stent System were presented today at the annual EuroPCR Scientific Program in Paris.

The NG PROMUS Clinical Trial evaluated the clinical and angiographic outcomes for the Promus PREMIER Stent System at 30 days.  John Ormiston, M.D., of Mercy Angiography, Auckland City, New Zealand is the primary investigator for the trial and presented data at the conference.

"The Promus PREMIER Stent demonstrated excellent safety and effectiveness with zero percent target lesion revascularization and stent thrombosis," said Dr. Ormiston.  "In addition, the rate of technical success, the primary endpoint of the trial, was very high at 99.2 percent.  The Promus PREMIER Stent System truly is a major step forward in stent technology."

The Promus PREMIER Stent System features the only customized stent architecture of its kind providing strength without compromising flexibility.  An enhanced low-profile delivery system with a shorter, more visible tip, dual-layer balloon and Bi-Segment™ inner lumen catheter is designed to facilitate precise stent delivery across challenging lesions.

Two-year follow-up data from the EVOLVE Trial were also presented today at EuroPCR by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.  The primary clinical and angiographic endpoints of this non-inferiority study, which compares the SYNERGY Stent to the PROMUS Element Stent, have already been published.

"The clinical results of the SYNERGY Stent in EVOLVE continue to impress with respect to safety and efficacy.  At two years, we see no increase in the 1.1 percent target lesion revascularization (TLR) and zero percent stent thrombosis rates that we observed in the full-dose SYNERGY Stent at one year," said Professor Meredith.  "Interestingly, the difference in TLR between the PROMUS Element Stent at 6.1 percent and the SYNERGY Stent at 1.1 percent is approaching statistical significance (p=0.07).  This is encouraging, as it supports our hypothesis that the bioabsorbable polymer coating could provide a long term benefit over durable polymer coated DES." 

The SYNERGY Stent features a bioabsorbable PLGA polymer and everolimus drug combination to create a low initial weight, ultra-thin, uniform coating that is applied to the abluminal (outer) surface of the stent.  The proprietary PLGA polymer completes absorption shortly after drug elution ends at three months, leaving only a bare platinum chromium stent. This technology provides the same level of restenosis reduction as a conventional everolimus-eluting stent while potentially offering faster and more complete vessel healing after stent implantation, which could reduce the required duration of post-procedure dual antiplatelet therapy.

"The Promus PREMIER and SYNERGY Stent Systems are the latest additions to our growing pipeline of drug-eluting stent technologies," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific.  "These innovations reflect our commitment to interventional cardiologists and the patients they serve."

Coronary heart disease is a narrowing of the vessels that supply blood and oxygen to the heart.  Recent statistics from the European Heart Network and the European Society of Cardiology show it is the single most common cause of death in Europe accounting for 1.8 million deaths in Europe per year.  Patients living with coronary heart disease, also known as coronary artery disease, may experience pain, shortness of breath and fatigue.  They may also be at risk for a heart attack.  One treatment option is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.  


======


Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP)
announced the successful completion and outcome of two pivotal Phase 3 studies to evaluate the efficacy and safety of budesonide foam in the treatment of active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). In each of the two pivotal Phase 3 studies, a statistically significant proportion of subjects treated with budesonide foam achieved clinical remission compared to subjects treated with placebo foam.

“We are pleased with the outcome of our pivotal studies of budesonide foam in the treatment of UP and UPS,” stated Bill Forbes, Executive Vice President, Medical, Research and Development and Chief Development Officer, Salix. “Patients with UP and UPS can be challenging to treat. Oral treatments may be limited by their ability to deliver drug to the rectum and sigmoid colon, and enema treatments may be limited by patients' ability to retain the liquid. Knowing this, our partner, Dr. Falk Pharma GmbH, developed budesonide foam which is approved and sold in Europe for the treatment of UP and UPS. We believe foam formulations provide important advantages over enema formulations principally with respect to drug retention and patient acceptance. We are working to submit a New Drug Application for budesonide foam as a treatment for UP and UPS by the end of September 2013. If approved, budesonide foam would be the first foam product approved in the United States for patients with UP (ulcerative colitis up to 10 cm from the rectum) as well as for patients suffering from UPS (ulcerative colitis up to 40 cm from the rectum). We believe this combination of using a high potency topical steroid with a delivery formulation that covers both UP and UPS would be a valuable addition to the available therapies for these patients.”

The two randomized, double-blind, placebo-controlled, multicenter studies in subjects who present with a diagnosis of active mild to moderate UP or UPS were designed to establish the efficacy profile of rectally administered budesonide foam administered as 2mg/25mL twice daily for two weeks followed by 2mg/25mL once daily for four weeks, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule. During the study, subjects were allowed to maintain previously established oral 5-ASA treatment at doses up to 4.8 grams per day. The primary end point was the proportion of subjects who achieved remission defined as an endoscopy score of ≤ 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI), at the end of 6 weeks of treatment or withdrawal. Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced the successful completion and outcome of two pivotal Phase 3 studies to evaluate the efficacy and safety of budesonide foam in the treatment of active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). In each of the two pivotal Phase 3 studies, a statistically significant proportion of subjects treated with budesonide foam achieved clinical remission compared to subjects treated with placebo foam.

“We are pleased with the outcome of our pivotal studies of budesonide foam in the treatment of UP and UPS,” stated Bill Forbes, Executive Vice President, Medical, Research and Development and Chief Development Officer, Salix. “Patients with UP and UPS can be challenging to treat. Oral treatments may be limited by their ability to deliver drug to the rectum and sigmoid colon, and enema treatments may be limited by patients' ability to retain the liquid. Knowing this, our partner, Dr. Falk Pharma GmbH, developed budesonide foam which is approved and sold in Europe for the treatment of UP and UPS. We believe foam formulations provide important advantages over enema formulations principally with respect to drug retention and patient acceptance. We are working to submit a New Drug Application for budesonide foam as a treatment for UP and UPS by the end of September 2013. If approved, budesonide foam would be the first foam product approved in the United States for patients with UP (ulcerative colitis up to 10 cm from the rectum) as well as for patients suffering from UPS (ulcerative colitis up to 40 cm from the rectum). We believe this combination of using a high potency topical steroid with a delivery formulation that covers both UP and UPS would be a valuable addition to the available therapies for these patients.”

The two randomized, double-blind, placebo-controlled, multicenter studies in subjects who present with a diagnosis of active mild to moderate UP or UPS were designed to establish the efficacy profile of rectally administered budesonide foam administered as 2mg/25mL twice daily for two weeks followed by 2mg/25mL once daily for four weeks, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule. During the study, subjects were allowed to maintain previously established oral 5-ASA treatment at doses up to 4.8 grams per day. The primary end point was the proportion of subjects who achieved remission defined as an endoscopy score of ≤ 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI), at the end of 6 weeks of treatment or withdrawal.


Also Wednesday:


Alkermes plc (NASDAQ: ALKS)
today announced that clinical data on ALKS 5461, a novel drug candidate for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, and ALKS 3831, a novel antipsychotic candidate for the treatment of schizophrenia, are scheduled to be presented at the 53rd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Fla., May 28-31, 2013.

Ambit Biosciences Corporation (Nasdaq: AMBI)
today announced that data from clinical investigations of quizartinib (AC220), a potent and selective FLT3 inhibitor, will be presented at the Annual Meeting of the American Society of Clinical Oncology, held May 31 through June 4, 2013, at McCormick Place in Chicago.

Boston Scientific Corporation (NYSE: BSX)
reports positive results from a pre-specified analysis of the first 60 patients enrolled in the REPRISE II trial evaluating the performance and safety of the Lotus™ Valve System in symptomatic patients with severe aortic valve disease considered at high risk for surgical valve replacement. 

Celsion Corporation (NASDAQ: CLSN)
announced today that its proprietary patent application, "Method of Storing Nanoparticle Formulations," has now been granted in the four largest markets for liver cancer globally:  China, Japan, South Korea and most recently Taiwan.

Cellular Biomedicine Group (OTCQB: CBMG)
today announced that it has achieved half of the enrollment of the total projected enrollment required for its Phase I trial to evaluate the safety and preliminary efficacy of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer.

Cleveland BioLabs, Inc. (NASDAQ: CBLI)
today announced that the Company is scheduled to present at the Second Annual Marcum LLP Microcap Conference, May 30, in New York, NY.

Corgenix Medical Corporation (OTCBB: CONX)
, a worldwide developer and marketer of diagnostic test kits, announced today that it has entered into a collaboration agreement with Eli Lilly and Company (NYSE: LLY) to develop diagnostic technology in support of a Lilly oncology pipeline program.

Covidien (NYSE: COV)
, a leading global provider of healthcare products, today announced that results from a prospective, multicenter, randomized, controlled clinical trial show that endoscopic ablation therapy using the Barrx™ RF Ablation System is effective at eliminating Barrett’s esophagus, a pre-cancerous condition of the esophagus, and preventing disease progression.

Generex Biotechnology Corporation (OTCBB: GNBT)
today announced three presentations demonstrating the superiority of the AE37 breast cancer vaccine being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).

iBio, Inc. (NYSE MKT: IBIO)
today announced the production of a vaccine candidate for the newly emerged H7N9 influenza virus by an independent third party laboratory using the iBioLaunch™ platform.

ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC)
today announced that Andrew Gengos, Chief Executive Officer of ImmunoCellular, will present a corporate overview and business update at the Marcum MicroCap Conference on Thursday, May 30, 2013 at 9:00 am ET at the Grand Hyatt hotel, New York, New York.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
will be presenting at Deutsche Bank's 38th Annual Health Care Conference on May 29, 2013, at 4:15 p.m. ET in Boston, MA.

Mauna Kea Technologies (NYSE Euronext: MKEA)
, leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, today announced that optical biopsies using a microscope so tiny it fits through a small needle show clear cellular-level images inside pancreatic cysts, which could assist physicians in the diagnosis of pancreatic cystic tumors and help patients with benign cysts avoid unnecessary surgery, according to new data presented at Digestive Disease Week 2013, which concludes here today.

MMRGlobal, Inc. (OTCQB: MMRF)
today announced that it will provide a free MyEsafeDepositBox or MyMedicalRecords Personal Health Record (PHR) account for anyone affected by the Oklahoma tornado or anyone living in an area that could be threatened by tornadoes through the end of tornado season.

NanoViricides, Inc. (OTC: NNVC)
, has filed its quarterly report with the Securities and Exchange Commission on Wednesday, May 15th, in a timely fashion.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Lymphoseek® (technetium Tc 99m tilmanocept) Injection studies in patients with breast cancer, melanoma or head and neck cancer are being presented at the Joint International Oncology Congress (JIOC) from May 27-29, 2013 in San Francisco, CA.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, developer of clinically-relevant fluorescence imaging solutions for use in surgical and outpatient wound care procedures, today announced that Dr. Arun Menawat, the company's President and Chief Executive Officer, will present Novadaq's corporate overview at the Jefferies 2013 Global Health Care Conference. Novadaq is scheduled to present on June 4th at 4:30 p.m. Eastern Time in New York City.

Nuvilex, Inc. (OTCQB: NVLX)
is a diamond in the rough in the truest sense.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
, a leader in the development of novel therapeutics to target mechanisms of treatment resistance in cancer, today announced that four trials of its investigational compounds, custirsen and OGX-427, will be presented as "Trials in Progress" posters at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL from May 31 – June 4.

Ohr Pharmaceutical Inc. (OTCQB: OHRP)
, a pharmaceutical company focused on the development of novel therapeutics for unmet medical needs, today announced the appointment of June S. Almenoff, M.D., Ph.D., to its Board of Directors.

Protalex, Inc. (OTCBB: PRTX)
, a clinical-stage biopharmaceutical company, today announced that following a planned interim safety review by its independent Data Safety Monitoring Committee, the Company is continuing enrollment and increasing the dose for subjects in its multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (RA).

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, announces that Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics, will deliver a corporate update at the Jefferies 2013 Healthcare Conference taking place from June 3-6, 2013 in New York City.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP)
today announced the successful completion and outcome of two pivotal Phase 3 studies to evaluate the efficacy and safety of budesonide foam in the treatment of active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that the US Patent and Trademark Office granted patent 8,444,991 entitled "Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition."



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 

Newsletter