|Sunshine Heart Received FDA Approval for C-Pulse System's Pivotal Trial; OXiGENE's Phase 2 Data on ZYBRESTAT, PCV Presented at AAO Annual Meeting|
|By Staff and Wire Reports|
|Tuesday, 20 November 2012 20:04|
Sunshine Heart, Inc. (NASDAQ: SSH) announced it has received unconditional approval from the FDA to commence its pivotal U.S. trial for its flagship C-Pulse(R) Heart Assist System. "We are pleased to have expeditiously completed the approval process with the FDA. We are excited to evaluate the C-Pulse System's potential in treating patients suffering from Class III and ambulatory Class IV heart failure.
We also are eager to evaluate its clinical and economic impact in reducing re-hospitalization rates due to worsening heart failure as this represents the highest and most costly re-hospitalization rates plaguing the U.S. healthcare system today. All of us at Sunshine Heart are committed to expediting this next phase of technology advancement," commented Dave Rosa. Sunshine Heart plans to initiate the pivotal trial in North America in the fourth quarter of 2012. The Company has contacted a number of leading heart failure centers in the U.S. and to date is encouraged by the positive response to participate in the trial. The trial design will consist of 388-patients of which half will be implanted with the C-Pulse System.
The other half will be randomized to optimal medical therapy across 30-40 clinical sites. Sunshine Heart expects to receive revenues from trial sites for device implants as the FDA has granted CMS Category B3 status. Because of this designation, it is also anticipated that participating trial centers will be reimbursed by CMS and most private insurance providers. The trial will utilize the Company's next-generation single unit C-Pulse driver, which received approval for clinical trial use from the FDA in August, 2012, and has been in use in Canadian and U.S. patients currently on the device. The new driver features a single unit, which is lighter, quieter, approximately half the size of its predecessor,
OXiGENE, Inc. (NASDAQ:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced the presentation today of data from a Phase 2 trial of ZYBRESTAT (fosbretabulin) in patients with polypoidal choroidal vasculopathy (PCV), which has features similar to age-related macular degeneration (AMD), a degenerative eye disease.
PCV found more often in individuals of African-American and Asian descent is a disease involving abnormal blood vessels of the macula characterized by recurrent serosanguinous detachment of the retinal pigment epithelium (RPE), submacular hemorrhage and development of subretinal polyps with resulting vision loss. The FAVOR study (Fosbretabulin Against Vasculopathy of the Retina/Choroid) was a randomized, double-masked Phase 2 study conducted in 20 Asian patients at seven clinical trial sites, which compared the outcome of a single intravenous dose of ZYBRESTAT (15, 25, 35 or 45 mg/kg) with placebo. The data showed that there was a transient reduction in polyp activity seen with indocyanine green angiography (ICGA) in a patient treated with 15 mg fosbretabulin and a transient reduction in subretinal fluid seen on optical coherence tomography, or OCT, in a patient treated with 45 mg fosbretabulin. The proportion of eyes with worsened findings on OCT/ICGA was significantly higher in the placebo group (p=0.032). These data suggest that ZYBRESTAT even if administered only as a single dose intravenously may produce a transient reduction in both polyp activity and amount of subretinal fluid in patients with PCV, and that further clinical testing with a more practical topical formulation potentially in combination with photodynamic therapy (PDT), may be warranted. No drug-related serious adverse event was observed in the study.
The data were presented at the 2012 annual meeting of the American Academy of Ophthalmology, being held in Chicago, in a poster titled, "Phase 2 Clinical Trial of Intravenous Fosbretabulin in the Treatment of Polypoidal Choroidal Vasculopathy (Fosbretabulin Against Vasculopathy of the Retina/Choroid: FAVOR Study)" by Timothy Y. Y. Lai, MD, FRCS, FRCOphth , Chinese University Hong Kong, et al.
"We believe that ZYBRESTAT has potential as a treatment for PCV and other ocular diseases involving abnormal blood vessel formation, such as age-related macular degeneration, and could potentially improve upon injectable anti-angiogenic agents which are used to treat these diseases, but which may have limited efficacy," said Jai Balkissoon, MD, FACS, Vice President Clinical Development, OXiGENE.
OXiGENE has previously reported positive results from proof-of-concept Phase 2 studies using an intravenous formulation showing that ZYBRESTAT achieved the primary endpoint of stable disease in patients with myopic macular degeneration (MMD). OXiGENE has conducted preclinical studies with topical formulations of ZYBRESTAT which demonstrated attractive pharmacokinetic and safety properties and efficacy in destroying abnormal vasculature in a rat choroidal melanoma model. Data from the FAVOR study could be used to facilitate dose selection decisions for future clinical trials. OXiGENE is seeking collaborators for its ZYBRESTAT ophthalmology program, which could include future development of a topical-route ZYBRESTAT.
Abaxis, Inc. (NasdaqGS: ABAX), a medical products company manufacturing point-of-care blood analysis systems, announced today that Clint Severson, chairman and chief executive officer , will present at the 24th Annual Piper Jaffray Healthcare Conference on Wednesday, November 28, 2012 at 10:30 a.m. ET.
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today topline results from a clinical study that demonstrates Acura's NEXAFED (pseudoephedrine hydrochloride) is bioequivalent to the leading national brand product.
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centered on its proprietary anti-apoptosis therapeutic protein MANF, today announced the Opposition Division of the European Patent Office upheld Amarantus Bioscience's European Patent relating to neurotrophic factor MANF, following opposition by rival Hermo Pharma OY of Finland.
Amgen (NASDAQ: AMGN) will present at the 24th Annual Piper Jaffray Healthcare Conference on Wednesday, Nov. 28, 2012, at the New York Palace hotel in New York City, beginning at 11:30 a.m. Eastern Standard Time.
Regenerative medicine company AvitaMedicalLtd. (ASX: AVH) (OTCQX: AVMXY) has initiated a multicenter randomized control study on the use of ReCell® Spray-On Skin® in the treatment of venous leg ulcers.
Bazi International, Inc. (OTCQB: BAZI), and its operating subsidiary True Drinks, Inc. ("Bazi"), today announces the launch of its new AquaBall™ website, www.theaquaball.com. AquaBall is the company's naturally flavored, vitamin-enhanced water drink.
FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that it completed a private placement on November 19, 2012 of its shares of common stock and warrants in the aggregate amount of $1,546,250.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that President and CEO, Bruce Barclay, is scheduled to present at the 24th Annual Piper Jaffray Healthcare Conference.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that Brian Zambrowicz, Ph.D., Executive Vice President and Chief Scientific Officer, will present at the Piper Jaffray Annual Healthcare Conference on Tuesday, November 27th, at 12:30 p.m. EST in New York City.
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), today announced results from an independent preclinical study on the cross-protection effects of Medicago's H5N1 VLP vaccine candidate ("H5N1 VLP vaccine").
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 will present at the Canaccord Genuity Medical Technology & Diagnostics Forum in New York City.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the 24th Annual Piper Jaffray Healthcare Conference in New York.
Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, coagulopathies and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, is scheduled to present at the 24th Annual Piper Jaffray Health Care Conference next week.
Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it will be presenting at the 24th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27, 2012 at 3:10 p.m. Eastern Time.
QuaDPharma, LLC (Clarence, NY) (www.qdpharma.com) has completed a $1 million financing investment from Rand Capital SBIC, Inc. (Buffalo, NY) (www.randcapital.com) (NASDAQ: RAND) and Advantage Capital Partners (Glens Falls, NY) (www.advantagecap.com).
Quidel Corporation (NASDAQ: QDEL), a leading provider of diagnostic testing solutions and cellular-based virology assays, announced today that it will present at the 24th Annual Piper Jaffray Healthcare Conference to be held at The New York Palace hotel in New York, NY on Tuesday, November 27, 2012.
Synergetics USA, Inc. (NASDAQ: SURG) announced today that it will host a conference call the morning of Tuesday, December 11, 2012, at 10:30 a.m. Eastern time to review the Company's results for the fiscal first quarter ended October 31, 2012.
Shire plc (LSE: SHP, NASDAQ: SHPG) and Boston Children's Hospital today announced a three-year, broad research collaboration in rare diseases.
Sigma-Aldrich® Corporation (Nasdaq: SIAL) announced that Sigma Life Science, its innovative biological products and services business, today launched its CompoZr®Transporter Knockout human cell lines in a consumable, assay-ready plate format.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that Verisante's Aura™, the revolutionary skin cancer detection device, has been named a finalist for the 2013 Prism Awards in the Life Sciences and Biophotonics category.
YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company advancing hematology and cancer related products,today announced that Kapil Dhingra has been elected by shareholders to the Company's Board of Directors at YM's Annual Meeting of Shareholders held this afternoon.