Abiomed Inc. Announces Clinical Trial Results For RECOVER RIGHT; Oncolytics Reports from US Randomized Phase 2 Pancreatic Cancer Study Print E-mail
By Josh Gee   
Tuesday, 16 September 2014 19:32

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 16, 2014. Abiomed Inc. (Nasdaq: ABMD), a leading provider of breakthrough heart support technologies, today announced clinical trial results from RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella RP™ (Right Percutaneous) System. The clinical trial results demonstrated a survival rate of 73% in the overall patient population.

RECOVER RIGHT was an FDA-approved, prospective, multicenter, single arm study designed to evaluate the safety and probable benefit of the Impella RP in patients with right ventricular failure (RVF) refractory to medical treatment and deemed to require hemodynamic support.

The 30 patients enrolled in the RECOVER RIGHT trial were categorized into two patient cohorts. Cohort A included patients who developed RVF within 48 hours after implantation of a left ventricular assist device (LVAD). Cohort B examined patients who developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction (AMI) shock. The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy.

Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3% and Cohort B had a 58.3% survival rate at 30 days.

"Right-side heart failure carries a high risk of mortality, and historically has been difficult for physicians to treat minimally invasively. The data from this trial is encouraging, and demonstrates that the Impella RP may play a pivotal role in the treatment of RVF patients in need of hemodynamic support in the future here in the U.S.," said William O'Neill, M.D., co-principal investigator for the RECOVER RIGHT trial and medical director of structural heart disease at Henry Ford Hospital.

"The Impella RP is the first percutaneous, single vascular access pump designed for right heart support. The pump is designed to be used concurrently with other left ventricle pumps in the Impella platform, which in the future may offer physicians the option of percutaneous biventricular support for acute patients," said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.

"The trial results were favorable and the 30-day outcomes appear promising compared with clinical data from surgical RV assist devices; however our study was not designed for a statistical comparison. Overall, the results show that the percutaneous approach with Impella RP potentially offers significant advantages to patients," said Mark Anderson, M.D., co-principal investigator for the RECOVER RIGHT trial and chair of the division of cardiothoracic surgery at Einstein Medical Center.

The trial results, "A Prospective, Multicenter Study to Evaluate a New Percutaneous Ventricular Assist Device for Right Ventricular Failure: The RECOVER Right Study," were presented today by Dr. O'Neill at the Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) 2014 scientific meeting in Washington, DC.

The Company also announced last week that it has completed its FDA submission of RECOVER RIGHT trial data for the Human Device Exemption (HDE) submission.

*The Impella RP is the subject of an investigational device exemption (IDE) clinical study and is limited by federal law to investigational use. The Impella RP currently is not available for sale in the United States.


Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) announced overall and KRAS-mutated patient data from a two-arm randomized phase 2 study of carboplatin, paclitaxel plus REOLYSIN® (test arm) versus carboplatin and paclitaxel alone (control arm) in the first line treatment of patients with recurrent or metastatic pancreatic cancer (NCI-8601). The trial is sponsored by the U.S. National Cancer Institute (NCI) through a clinical trials agreement between the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis and Oncolytics. Oncolytics provided clinical supplies of REOLYSIN® for the study and paid for the immune and genetic testing of the patients.

Summary Findings -- The overall objectives of the study were to determine the progression free survival of the overall patient population and the patient population according to KRAS mutation status.

Overall patient population -- The study enrolled 73 patients; 37 were in the control arm, 36 were in the test arm. The median progression free survival for the control arm was 5.16 months (95% confidence interval (CI) = 2.267 to 6.176) versus 5.26 months for the test arm (95% CI = 3.187 to 6.307).

KRAS mutated patient population -- As part of the study design, patients were screened for KRAS status at codon 12. Of the 60 patients where KRAS status could be determined (mutant vs wild type), 44 (73%) had mutations in the KRAS gene (n = 23 in the control arm, n = 21 in the test arm). Median progression free survival in the test arm was 5.72 months (95% CI = 3.187 to 6.767) versus 4.11 months in the control arm (95% CI = 1.938 to 6.176). This translates into a 1.61 month (39%) improvement in median progression free survival in the test arm versus the control arm. Three patients on the test arm and one on the control arm had not progressed as of the time of analysis.

Crossover patient population -- Patients on the control arm who progressed on carboplatin and paclitaxel had the option of adding REOLYSIN® to their regimen. At the time of the analysis, 16 patients crossed over to the test arm regime. The best responses after crossover were one partial response (PR), six stable disease (SD), seven progressive disease (PD), and two not evaluable, giving a disease control rate (complete response (CR) + PR + SD) of 50% in the carboplatin and paclitaxel failed group.

"This is the first randomized clinical evidence that screening patients for their KRAS status could influence their clinical outcomes when treated with a drug regime that includes REOLYSIN®," said Dr. Alan Tuchman, Senior Vice President, Medical and Clinical Affairs & Chief Medical Officer of Oncolytics. "These findings support previous evidence of REOLYSIN® being active in cancer cells with an activated RAS pathway and warrants confirmation of KRAS status as a potential predictive biomarker in future studies."

The study was an open-label, multi-institution, two-arm phase 2 randomized study of patients with metastatic pancreatic cancer. Patients were randomized to receive either carboplatin, paclitaxel plus REOLYSIN® (test arm) or carboplatin and paclitaxel alone (control arm). Patients in both arms received treatment every three weeks (21-day cycles) and standard intravenous doses of paclitaxel and carboplatin on day one only. In the test arm, patients also received intravenous REOLYSIN® at a dose of 3x1010 TCID50 on days one through five. Tumor response assessment was done by computed tomography (CT) scan and conducted every eight weeks. Patients who progressed on carboplatin and paclitaxel (control arm) had REOLYSIN® added. If patients experienced significant toxicity related to carboplatin and/or paclitaxel, they could continue with single agent REOLYSIN®.

The primary endpoint of the trial is to assess improvement in progression-free survival with REOLYSIN®, carboplatin and paclitaxel relative to carboplatin and paclitaxel alone in patients with metastatic pancreatic cancer. The primary endpoint is progression free survival in both arms. Secondary endpoints include safety, overall response rate, overall survival, immune factors and to prospectively establish and validate the relationship between Ras mutations in tumor samples and response to REOLYSIN®.

Also Tuesday:

Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that three-year results from the SUMMIT extension study on the clinical efficacy and safety of matrix-applied characterized autologous chondrocytes (MACI™) for treating cartilage defects will be presented in a poster session at the American Academy of Orthopedic Surgeons annual meeting in Las Vegas, Nevada starting on Tuesday, March 24, 2015.

ActiveCare, Inc. (OTCBB:ACAR)
, a leader in diabetes monitoring and wellness services for self-insured employers nationwide today announced an expansion of its diabetes management solution to several Native American Tribes across the country.

Agile Therapeutics, Inc., (Nasdaq:AGRX)
a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today announced the initiation of its Phase 3 study called SECURE (Study to Evaluate Contraceptive Use, Reliability and Effectiveness).

Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L)
, a leading designer and manufacturer of rapid diagnostic screening and testing products, announces that its Executive Chairman, Raymond F. Akers Jr., Ph.D, was featured on "The RedChip Money Report: Small Stocks Big Money" television program which was televised on Fox Business nationwide as well as Bloomberg Europe, UK and Asia.

eRAD, a subsidiary of RadNet, Inc. (Nasdaq:RDNT)
, a leading provider of standards-based, web-centric radiology image and data management solutions, announced today that Madison Radiology Medical Group has implemented eRAD RIS with Speech Recognition.

Eternity Healthcare Inc. (OTC:ETAH)
, a medical device and diagnostic company with advanced technologies using the Needle-Free Injection system announced today that its competitor company, PharmaJet® Inc., has received FDA clearance to use a Needle-Free Injection device to administer the influenza vaccine to the public.

FEI Company (Nasdaq:FEIC)
announced that its board of directors has approved payment of a quarterly dividend of $0.25 per share of common stock.

GreeneStone Healthcare Corporation (OTCBB:GRST)
, a provider of healthcare services including Addiction and Mental Health, is participating in the National Investment Banking Association Conference (NIBA) being held in New York City on September 16 - 18, 2014.

Kite Pharma, Inc. (Nasdaq:KITE)
, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that Arie Belldegrun, M.D., FACS, President and Chief Executive Officer, will provide an overview of the Company at the 21st Annual BioCentury NewsMakers Conference during a live presentation at 11:30am ET.

Landec Corporation (Nasdaq:LNDC)
will hold a conference call on Wednesday, October 8, 2014 at 8 a.m. Pacific time to discuss its results for the first quarter fiscal year 2015.

Materialise (Nasdaq:MTLS)
, a pioneer in 3D Printing for medical applications, recently created a 3D-printed heart model for doctors at Cincinnati Children's Hospital to support Bradley White's case, a 16-year-old boy who was born with a tumor.

Medical Marijuana Inc.'s (OTC Pink:MJNA)
HempMeds™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for Medical Marijuana, Inc. – is proud to sponsor Natural Products Expo East. HempMeds™, a pioneer of cannabidiol (CBD)-rich (hemp) cannabis products, is exhibiting from booth #4215 and will reach an estimated 25,000 natural product buyers during the two-day expo.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced Willis-Knighton Health System, a large non-profit community healthcare organization with four hospitals in the Shreveport and Bossier City, La. area comprising of a 600+ physician network, has selected Merge's enterprise-wide cardiology and interoperability solutions to simplify workflow and advance clinical reporting and analytics.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 2 clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy women in the third trimester of pregnancy.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 33 countries, today announced the allowance of four new U.S. and international patents for the company's flagship technology, Microcyn®.

Phibro Animal Health Corporation (Nasdaq:PAHC)
today announced its financial results for its fourth quarter and fiscal year ended June 30, 2014.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that Adi Frish, RedHill's Senior VP Business Development and Licensing, will be presenting at the 14th Annual Biotech In Europe Forum for Global Partnering & Investment, on Tuesday, September 30, 2014, at 12:00 p.m. EDT, in the Darwin room of the Congress Center Basel in Basel, Switzerland.  

REVA Medical, Inc. (ASX:RVA)
is pleased to announce that Dr. Alexandre Abizaid, Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology, in Sao Paulo, Brazil, presented information today on the Company's Fantom™ bioresorbable scaffold program at the Transcatheter Cardiovascular Therapeutics ("TCT") Conference, which is being held September 13th through 17th in Washington, DC.

ReWalk Robotics (Nasdaq:RWLK)
, a company dedicated to fundamentally changing the health and life experiences of individuals with spinal cord injuries, will visit the NASDAQ MarketSite in Times Square in celebration of its recent initial public offering (IPO).

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP)
announced today that Rick Matros, the Company's Chairman and Chief Executive Officer, Harold Andrews, the Company's Chief Financial Officer, and Talya Nevo-Hacohen, the Company's Chief Investment Officer, will be participating in upcoming conferences at the 2014 Jefferies Health Care REIT & Health Care Services Summit on September 30, 2014 and the 24th NIC National Conference October 1-3, 2014, both being held in Chicago, IL.

SAGE Therapeutics (Nasdaq:SAGE)
, a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced the appointment of Michael F. Cola to the company's board of directors.

The Spectranetics Corporation (Nasdaq:SPNC)
today announced that Eric Dippel, MD, at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, presented findings from the EXCITE ISR clinical trial proving Spectranetics' laser atherectomy devices, used with PTA (also known as balloon angioplasty), are clinically superior to PTA alone in both safety and efficacy, triggering a new standard in cardiovascular care.

Sunshine Heart, Inc. (Nasdaq:SSH)
announced today that follow-up data from six patients implanted with the C-Pulse® Heart Assist System at St. Luke's Hospital – Mid America Heart Institute, as part of a FDA approved, North American Feasibility Study, will be presented later today by Dr. Sanjeev Aggarwal, MD, Director of Mechanical Circulatory Support at Saint Luke's Mid America Heart Institute.


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