|Second Sight Announces Positive Results of the Argus II Retinal Prosthesis System; DURECT Announces Plans for a New POSIDUR Clinical Trial|
|By Josh Gee|
|Tuesday, 23 June 2015 19:28|
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 23, 2015.
Second Sight Medical Products, Inc. (NASDAQ: EYES), a developer, manufacturer and marketer of implantable visual prosthetics to provide some useful vision to blind patients, announced positive three year results post-implant of its Argus® II Retinal Prosthesis System ("Argus II") from a multi-center clinical trial.
The paper titled, "Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind", highlights 30 subjects implanted with the Argus II at 10 centers throughout the United States and Europe. Three types of visual function tests were performed using computer-run assessments: square localization (i.e. object detection), direction of motion (i.e. motion detection) and discrimination of oriented gratings (i.e. visual acuity). Two types of real-world orientation and mobility (O&M) tests were also performed: a test where subjects were asked to locate and touch a door, as well as a test where subjects were asked to follow a white line on the floor. In the absence of existing validated quality of life tools for this population, a Functional Low-vision Observer Rated Assessment (FLORA) was also performed by independent visual rehabilitation experts at the request of the FDA to assess the impact of the Argus II system on the subjects' everyday lives, including extensive interviews and tasks performed around the home.
Of the 30 subjects tested, 29 remained implanted with functioning Argus II systems at three years post-implant. Results showed that with the Argus II System, improvements in visual function and O&M were maintained out to three years. Up to 89 percent of subjects performed statistically better with the Argus II system implanted compared with native residual vision in visual function tasks at year three. During the trial, the FLORA also demonstrated that up to 80 percent of the subjects received benefit from the system when considering both functional vision and patient-reported quality of life, and no subjects were affected negatively. The results of the trial support the long-term safety profile and benefit of the Argus II for individuals who are blind due to retinitis pigmentosa (RP).
"The data from this study is quite remarkable for these patients who, previously, had little to no light perception, living in a world that we could consider complete darkness," said Dr. Allen C. Ho, MD FACS, Director of Retina Research, Wills Eye Hospital and Professor of Ophthalmology, Thomas Jefferson University. "The fact that these individuals have increased independence, being able to navigate through their home, walk through doorways and cross streets, is truly life changing."
"We are thrilled to see positive results from this study, supporting the safety and benefit of the Argus II," said Dr. Robert Greenberg, President and CEO of Second Sight. "The results from the trial demonstrated long-term reliability of the device, long-term benefit to the users, and an acceptable safety profile. Together, these results show that the Argus II provides a substantial visual improvement over blindness. Having this device backed by significant, long-term clinical data is cause for great hope among those individuals suffering from RP and should further our efforts across the globe in securing regulatory and reimbursement approvals."
Dr. Greenberg continued, "Of course, this is only the beginning. We are constantly making improvements in our technology and are striving to greatly improve image quality and resolution for the Argus II. With our ongoing development efforts toward the Orion I Cortical Visual Prosthesis, we hope to offer a solution for people living with blindness from nearly all causes."
Earlier results from this trial were used to gain approval of the Argus II by the FDA in addition to CE Mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. Although there are several research efforts in retinal prostheses worldwide, none have demonstrated the reliability and efficacy of such a device in a multi-centered, long-term, controlled clinical trial involving 30 subjects, as was demonstrated by the Argus II in this study.
DURECT Corporation (NASDAQ: DRRX) announced, based on feedback from the FDA, it plans to conduct a new POSIDUR™ (SABER®-Bupivacaine) Phase 3 clinical trial consisting of approximately 300 patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. DURECT anticipates beginning the trial in the fall of 2015 and expects that it will take approximately one year to complete enrollment.
"With the FDA's guidance in hand, we now have a clear path forward for POSIDUR," stated James E. Brown, President and CEO of DURECT. "We believe that the data from this additional clinical trial will be supportive of the data we have seen in our other pivotal trials in hernia repair and shoulder surgery, and that these three pivotal trials will support a robust NDA resubmission, for which there would be a 6 month review per PDUFA guidelines. We have previous clinical trial experience with laparoscopic cholecystectomy, which is one of the most common general surgeries performed in the U.S. each year. We believe this is an excellent surgical model and that our overall clinical program for POSIDUR will support a broad label."
About the new Phase 3 Clinical Trial -- The study will be a randomized, parallel-group, double-blind, placebo-controlled, multicenter trial of POSIDUR in patients undergoing laparoscopic cholecystectomy. The objective of the study will be to evaluate the safety and efficacy of POSIDUR for the management of postoperative pain. Approximately 300 patients will be randomized on a one-to-one basis to receive either POSIDUR or placebo as a one-time intra-incisional instillation at the close of surgery. The primary efficacy endpoint will be pain intensity on movement over 0-72 hours after surgery.
Laparoscopic cholecystectomy -- Cholecystectomy is a surgical procedure for removal of the gallbladder. Laparoscopic cholecystectomy, which is done using a camera and instruments inserted through a set of small incisions in the abdomen, has largely supplanted the traditional open approach, which requires an abdominal incision several inches in length. Approximately 800,000 such procedures are performed in the U.S. each year, most of them on an outpatient basis.
In a previous clinical trial consisting of 50 patients, when using the statistical analysis that will be employed in the upcoming trial, POSIDUR demonstrated an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.0235) when compared with the active control bupivacaine hydrochloride.
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced that the company's board of directors has appointed Maykin Ho, Ph.D., former partner at the Goldman Sachs Group, as an independent director to the company's board.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced that it leads the market in electronic health record (EHR) usability.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based revenue cycle management applications and telehealth products and services for healthcare organizations, today announced that William P. Henry, an experienced technology executive, was elected to Authentidate's Board of Directors, expanding the number of directors to eight persons.
Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR), a leader in functional and renewable plant proteins, reported results for the fiscal fourth quarter and year ended March 31, 2015.
Caladrius Biosciences, Inc. (Nasdaq:CLBS), a cell therapy leader with a late-stage clinical program for immuno-oncology, announced today the dosing of the first patient in the Intus Phase 3 clinical trial. The Intus trial is investigating the efficacy of the Company's patient-specific targeted cancer immunotherapy candidate CLBS20 (also known as NBS20).
Calithera Biosciences, Inc. (Nasdaq:CALA), announced today at the JMP Securities Life Sciences Conference in New York City, the selection of CB-1158 as the clinical candidate for their immuno-oncology program targeting inhibition of arginase, a critical immunosuppressive enzyme secreted by myeloid-derived suppressor cells (MDSCs) in tumors.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced that it has completed enrollment in its Phase 2 proof-of-concept trial of its lead kappa opioid agonist, CR845, for the treatment of uremic pruritus (UP).
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today reported financial results for the third quarter of fiscal 2015 and provided an update on its progress.
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that it is set to join the Russell 3000®, Russell 2000®, and Russell Microcap® Indexes at the conclusion of the annual reconstitution of Russell indexes on June 26, 2015.
EXL (Nasdaq:EXLS), a leading business process solutions company, today announced it has named Scott McFarland as Senior Vice President and General Manager of EXL Healthcare's Platform Technology business (formerly EXL Landa).
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced that it has filed a shelf registration statement on Form S-3 with the United States Securities and Exchange Commission ("SEC").
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range of solutions to advance life science, is set to simultaneously join two broad-market Russell indexes. According to Russell's preliminary list of additions, the Company is expected to be added to the Russell 3000® Index and the Russell Global Index at the conclusion of the annual Russell indexes reconstitution on June 26, 2015.
IGC, Inc. (NYSE-MKT: IGC) announces that the company applied for a provisional patent based on a novel therapy that uses extracts from the cannabis plant for the treatment of multiple seizure disorders and medical refractory epilepsy.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced initiation of enrollment for the second Phase 3 clinical trial (ITI-007-302) of the Company's lead product candidate ITI-007.
MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced that MTBC's CEO, Mahmud Haq, has been awarded the 2015 Outstanding 50 Asian Americans in Business Award by the Asian American Business Development Center.
Nivalis Therapeutics, Inc. (Nasdaq:NVLS), a clinical stage pharmaceutical company focused on treating people with cystic fibrosis, announced today the closing of its initial public offering of 6,325,000 shares of its common stock at a price to the public of $14.00 per share, which included 825,000 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares, for aggregate proceeds of $88.55 million, before underwriting commission and discounts and offering expenses.
Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that it will host a Key Opinion Leader breakfast focused on the treatment landscape for myelodysplastic syndromes (MDS), including the Company's late-stage drug candidate, rigosertib, a small molecule RAS mimetic that inhibits cellular signaling.
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry today announced the dosing of the first patient in its Phase 3 clinical trial of its lead drug candidate, omadacycline, for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
Praxsyn Corporation's (OTCQB:PXYN) wholly owned subsidiary, Mesa Pharmacy, Inc. (Mesa), a medication and service provider for medical practitioners, is pleased to announce the launch of its fully-featured website www.mesapharma.com.
Profound Medical Corp. (TSX-V:PRN) is pleased to announce the results of the votes on the matters considered at its Annual Meeting of Shareholders that was held on June 22, 2015.
SANUWAVE Health, Inc. (OTCQB:SNWV), announced today the receipt of U.S. Pat. No. 9,057,232 from the U.S. Patent and Trademark Office entitled "Apparatuses and Methods for Generating Shock Waves for Use in the Energy Industry" that has a patent life to April 2033.
The Shareholders Foundation, Inc. announces that a lawsuit was filed on behalf of certain purchasers of shares of Puma Biotechnology Inc (NYSE:PBYI) over alleged Violations of Federal Securities Laws by Puma Biotechnology Inc.
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the JMP Securities Life Sciences Conference on Wednesday, June 24, 2015 at 3:30 PM ET.
Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver therapeutics conveniently through the skin for the treatment of a variety of indications, today announced that it has completed enrollment in its Phase 2 clinical trial of ZP-Glucagon, a novel investigational patch treatment for severe hypoglycemia in diabetics.