|Ocata Successfully Completes Dosing in Phase 1/2 RPE Studies; Capricor Completes Enrollment of Phase II Clinical Trial for Cenderitide|
|By William Kent|
|Tuesday, 31 March 2015 19:33|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 31, 2015.
Ocata Therapeutics, Inc. (NASDAQ:OCAT), announced the company has completed dosing of its Phase 1/2 studies for dry age-related macular degeneration (AMD) and Stargardt's Macular Degeneration (SMD). A total of 38 patients have been safely dosed. The 200,000 cell cohort, the highest level planned was successfully completed, paving the way for the next phase of the programs.
"With successful completion of dosing for the phase 1/2 studies at the highest dose level, and following safety data review by the Data and Safety Monitoring Board, we are now able to focus on initiation and execution of our Phase 2 study for AMD and our pivotal study for SMD," said Paul K. Wotton, President and Chief Executive Officer of Ocata Therapeutics, who added, "We believe that data from the AMD studies will also be an important inflection point for the entire retinal pigment epithelium (RPE) program. As we have previously announced, we have received guidance from the European Medicines Agency indicating that our SMD program can be initiated as a pivotal clinical trial."
The objective of the SMD trial will be to assess the safety and efficacy of subretinal transplantation of RPE cells compared to an untreated control group. The endpoints of the trial include functional and anatomic outcome parameters. The AMD trial will evaluate the safety of different regimens of immunosuppressive therapy while exploring functional and anatomic efficacy outcome parameters.
Ocata previously announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for its RPE therapy for macular degeneration. The SMD program has orphan status both in Europe and the US.
Capricor Therapeutics, Inc. (NASDAQ: CAPR), announced it has completed enrollment of its first Phase II clinical trial of Cenderitide in ambulatory heart failure patients. Cenderitide is in development for the outpatient treatment of patients following an acute admission for heart failure, as well as other potential indications.
The trial completed enrollment of 14 patients. Patients received up to eight consecutive days of increasing doses of Cenderitide by continuous subcutaneous infusion using Insulet's OmniPod® drug delivery system. The trial assessed the safety, tolerability, pharmacokinetic profile and pharmacodynamic response to increasing dose levels of open-label Cenderitide administered in a stepwise fashion, with each patient receiving the entire range of doses.
"This Phase II trial is an important step in our clinical development program aimed at treating heart failure patients on an outpatient basis," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "Given the enormous unmet clinical need and heart failure being responsible for over 1 million hospital admissions annually and the staggering re-admission rates for these patients, the goal of this trial is to develop the potential use of Cenderitide as a therapy for patients with clinically advanced heart failure. We believe that, if approved, Cenderitide administered via a patch pump delivery system such as the OmniPod® drug delivery system could keep patients out of the hospital and potentially lower overall costs on the healthcare system. Cenderitide is a dual receptor natriuretic peptide and recent positive results in Novartis' PARADIGM-HF trial have shown that the mechanism of action of their ARNI (angiotensin receptor neprilysin inhibitor) can raise the level of endogenous natriuretic peptides by preventing their enzymatic breakdown in chronic heart failure patients. We look forward to reporting on top line data from this trial during the second half of 2015 and announcing further clinical development plans in the coming months."
Heart Failure -- According to the American Heart Association, heart failure is the leading cause of hospitalization among adults older than 65 years of age in the United States and is responsible for over 1 million hospital admissions annually. Among those patients that have been admitted, approximately 24% are re-hospitalized within one month, and 50% are re-hospitalized within six months. Additionally, the Affordable Care Act may not allow Medicare payments for heart failure re-hospitalizations within 30 days.
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that United States Patent and Trademark Office (USPTO) issued US Patent No. 8,987,333 entitled "Composition and Method for Treating Neurological Disease."
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today its expected participation in the following investor conference: 14th Annual Needham Healthcare Conference; Tuesday, April 14, 2015, 9:20 AM Eastern Time New York, NY.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development therapeutics for cancer and other life threatening diseases, today announced financial results for the quarter and year ended December 31, 2014 and provided an update on recent clinical developments for its lead compound, onapristone.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, today reported financial results for the three months and year ended December 31, 2014.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, today reported that it has filed a 510(k) Premarket Notification with U.S. Food and Drug Administration (FDA) for regulatory clearance of an additional indication for the BGM Galectin-3 Test.
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it has completed enrollment of its first Phase II clinical trial of Cenderitide in ambulatory heart failure patients.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today reported full-year and fourth quarter 2014 financial results for the period ended December 31, 2014.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first sale of Focal One HIFU device to Jewish General Hospital, Montreal, Canada.
Emisphere Technologies, Inc. (OTCBB:EMIS) today reported financial results for the fourth quarter and full fiscal year ended December 31, 2014, and provided an overview of corporate accomplishments and plans.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will present a corporate update at the 14th Annual Needham Healthcare Conference.
GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces it has initiated the Phase 3 part of a Phase 2/3 clinical trial of Epidiolex® (cannabidiol or CBD) for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. GW anticipates that top-line data from this trial will be available around the end of 2015.
Herborium® Group, Inc.(OTC Pink: HBRM), a Botanical Therapeutics® Company and the provider of unique all botanical medicinal products (Botanical Therapeutics®) that target dermatological problems such as acne, and other major health and wellness concerns reports that its sales for the First Quarter of 2015 grew by 21% in comparison to the same period of 2014.
iKang Healthcare Group, Inc. (Nasdaq:KANG), today announced that the Company's Board of Directors has appointed Mr. Gavin Zhengdong Ni as an independent director and a member of the Audit Committee of the Board, effective March 31, 2015.
Immune Design Corp. (Nasdaq:IMDZ), a clinical-stage immunotherapy company, today reported financial results and provided a corporate update for the fourth quarter and full year ending December 31, 2014.
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on cancer, reported today that analyses of data from three ongoing Phase 1 studies support continued development of its two primary product candidates, CMB305 and G100.
INC Research Holdings, Inc. (Nasdaq:INCR), a leading, global Phase I to IV contract research organization, together with the Society for Clinical Research Sites (SCRS), the global trade organization fully dedicated to representing the interests of clinical research sites, today announced they have collectively awarded scholarships to more than 100 sites worldwide through the SCRS Site Scholarship Program.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the home care setting, announced today that it will file a Form 12b-25 Notification of Late Filing with the U.S. Securities and Exchange Commission with regard to its Annual Report on Form 10-K for the year ended December 31, 2014.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, today announced the pricing of an underwritten public offering of 1,200,000 shares of its common stock.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, presented data regarding the ITI-007 development program and described the rationale supporting the strategy for the advancement of ITI-007 in multiple clinical indications at the 15th International Congress on Schizophrenia Research (ICOSR) in Colorado Springs.
LifeVantage Corporation (Nasdaq:LFVN), has announced that Vice President of Product Development Nathalie Chevreau, PhD is presenting a poster abstract at the Experimental Biology 2015 Boston meeting.
MedAssets, Inc. (Nasdaq:MDAS) today announced that it plans to release its financial results for the first quarter ended March 31, 2015 after 4:00 p.m. ET on Wednesday, April 29, 2015.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the closing of the underwritten public offering priced on Wednesday, March 25, 2015.
Nuo Therapeutics, Inc. (OTCQX:NUOT) a pioneer in biodynamic therapies, today reported financial results for the year ended December 31, 2014.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today its financial results for the year ended December 31, 2014 prepared in accordance with International Financial Reporting Standards.
Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced the availability in the United States of a new test that measures the strength of a patient's cellular immune response to cytomegalovirus (CMV).
Pazoo, Inc. (OTCQB:PZOO) (German WKN#: A1J3DK) is pleased to present to the investment community an update on where Pazoo stands today and the plan for an aggressive growth strategy moving forward. Pazoo on Friday March 27, 2015 filed a preliminary 14C Information Statement with the SEC advising of an increase to the authorized shares from approximately 1 billion shares to 3 billion shares and will logically explain why these steps are necessary for the overall company to accomplish the aggressive expansion plans currently underway.
Peregrine Pharmaceuticals (Nasdaq:PPHM) (Nasdaq:PPHMP), today announced the peer-reviewed publication of clinical data from a Phase I investigator-sponsored trial evaluating the company's lead investigational immunotherapy bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced its consolidated financial results and business progress for the fourth quarter and full year ended December 31, 2014.
Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, will hold an Investor conference call on Tuesday, March 31, at 4:20 p.m. (EDT) to discuss the Company's financial results for its full year 2014 and provide an update on its business initiatives.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced the appointment of Joseph L. Farmer as Senior Vice President, General Counsel and Secretary.