|Zogenix Announces First Patient Dosed in Relday Multi-Dose Clinical Study; pSivida Completes Targeted Enrollment of Phase III Trial of Medidur|
|By Marilyn Mullen|
|Thursday, 26 March 2015 19:01|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 26, 2015.
Zogenix, Inc. (NASDAQ: ZGNX), announced dosing has begun in patients enrolled in its Relday™ multi-dose Phase 1b clinical study. Relday is a proprietary, long-acting, subcutaneously injected formulation of risperidone being investigated for the treatment of schizophrenia.
Relday has been designed to provide potentially significant improvements over current long-acting injection treatment options for patients suffering from schizophrenia. In a Phase 1 single-dose clinical study in schizophrenic patients, Relday demonstrated the ability to achieve therapeutic plasma levels of risperidone on the first day of dosing, followed by a controlled release profile over the remaining four-week period. This pharmacokinetic profile of Relday may eliminate the requirement for long-acting risperidone injections to be supplemented with daily oral therapy for several weeks during therapy initiation or when patients are not fully compliant with an injection regimen over the course of long-term therapy. In addition, dose-proportionality for Relday has been established across all doses, as well as the duration of treatment being consistent with once-monthly dosing. Unlike all currently marketed long-acting injectable treatment options which are administered via intramuscular injection, Relday is administered subcutaneously. Moreover, unlike some leading injectable products in the category, Relday does not require reconstitution prior to use.
Fifty-six subjects with schizophrenia or schizoaffective disorder are planned to be enrolled in this open label, multi-dose, safety and pharmacokinetic (PK) study. Subjects will be administered Relday or Risperdal® Consta® (risperidone), an approved long-acting intramuscular injectable with the same active ingredient as Relday. Patients being administered Risperdal Consta will also receive daily oral risperidone supplementation during a three-week initiation period, and will be dosed every two weeks, as required by its prescribing label. Subjects will be followed for up to 20 weeks in order to confirm and compare the time to reach drug concentrations within the therapeutic range and to compare steady state pharmacokinetics for Relday and Risperdal Consta. The Company anticipates that results from the Relday multi-dose study will be available in the third quarter of 2015.
The Company also plans to initiate efforts to secure an ex-U.S. strategic development and commercialization partner for Relday during this development stage and is targeting an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by early 2016. If completed, these milestones would position the Company to begin a Phase 3 clinical study for Relday in 2016.
Brad Galer, M.D., chief medical officer of Zogenix, stated, "We are pleased to move the Relday development program forward into this next clinical study. We expect the data to continue to demonstrate that Relday's novel formulation has a differentiated product profile amongst currently marketed long-acting injections for the treatment of schizophrenia that should enhance the treatment for this patient population."
In July 2011, Zogenix licensed from DURECT (NASDAQ: DRRX) exclusive global rights to develop and commercialize this proprietary formulation which utilizes DURECT's SABER® depot technology.
pSivida Corp. (NASDAQ:PSDV; ASX:PVA), announced the completion of the originally targeted enrollment of 120 patients in its pivotal Phase III clinical trial of Medidur™ for the treatment of posterior uveitis, a blinding eye disease. pSivida will permit 10 additional patients seeking entry into the trial who met the entry criteria to enroll. pSivida expects to report top line data from the trial in the second half of 2016, and based on the results, to file for regulatory approval in late 2016 or early 2017.
"This is a major advance in the treatment of uveitis, in my opinion, with the delivery of medication into the vitreous cavity without the need for travel to an operating room and with effective provision of corticosteroid for a sustained three years," said Dr. C. Stephen Foster, president and CEO of Massachusetts Eye Research & Surgical Institute; founder and president of Ocular Immunology and Uveitis Foundation and a clinical professor of ophthalmology at Harvard Medical School. Dr. Foster's site enrolled the most patients in the study.
Medidur is an injectable micro-insert delivering the steroid flucinolone acetonide (FA) on a sustained basis for 36 months. Medidur uses the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for diabetic macular edema (DME) developed by pSivida, which has been approved in the U.S. and in 15 EU countries to date. Medidur is inserted via a redesigned applicator that utilizes a needle of the same gauge as that typically used for intra-ocular injections.
Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness making it the third leading cause of blindness in the U.S.
Patients with posterior uveitis are typically treated with systemic steroids but over time frequently develop serious side effects that can limit effective dosing. Patients then progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.
"Based on results of a Phase II study and prior experience with this implant, we believe that Medidur will provide improved outcomes compared to standard of care but with a significant reduction in side effects. Medidur should also lower treatment costs and offer the reduced invasiveness of an injection every three years compared with the frequent administration of existing therapies," said Dr. Paul Ashton, President and CEO of pSivida Corp. "We are focused on providing solutions for retinal diseases and believe that this study will demonstrate the safety and effectiveness of Medidur."
The Medidur Phase III trial is a double-blind study comparing injections of Medidur to sham injections on a two-to-one basis. Patients are enrolled in 16 centers in the U.S. and 17 centers in the EU and India. The primary end point of the trial is recurrence of posterior uveitis within one year. pSivida plans to seek approval based on the safety and efficacy data from this single Phase III trial together with short term data from a utilization study of pSivida's proprietary inserter. The FDA has confirmed that pSivida can reference much of the data, including the clinical safety data, from the Phase III clinical trials of ILUVIEN for DME.
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it has opened enrollment for its Phase II clinical trial of NS2 for patients with noninfectious anterior uveitis.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutics and diagnostics in neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has opened and now has an active Investigational New Drug (IND) application with the Neurology Division of the U.S. Food and Drug Administration (FDA) to start a Phase 2b program of eltoprazine for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company announced today positive preclinical in vitro and in vivo proof-of-concept study results for its mitochondrial protein replacement therapy drug candidate (BB-FA) for Friedreich's Ataxia.
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today its financial results for the fiscal fourth quarter and year ended December 31, 2014.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced financial results for the fourth quarter and full year ended December 31, 2014.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the Company's participation in a major collaborative liver cancer project aimed at developing innovative new therapies for this prevalent indication.
ERBA Diagnostics, Inc. (NYSE MKT:ERB) announced that its wholly-owned subsidiary – Diamedix Corporation – has entered into a purchase and sale agreement to sell its former facilities located in Miami, Florida, for $23 million. ERBA Diagnostics intends to use the net proceeds from the sale of the property for potential facilities purchases, potential strategic acquisitions and for general working capital.
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on cancer, today announced the dosing of patients in a Phase 1b clinical trial of CMB305, a "prime-boost" immuno-oncology product candidate generated from the company's ZVexTM and GLAASTM platforms.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired GTA Health Solutions, a behavioral health post-acute practice headquartered in Morristown, Tennessee.
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 reported full-year and fourth quarter 2014 financial results for the period ended December 31, 2014.
LifeVantage Corporation (Nasdaq:LFVN), has announced the expansion of its its direct selling business into Thailand.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that it has priced an underwritten public offering of 24,137,931 shares of common stock at a price to the public of $7.25 per share for gross proceeds of approximately $175 million.
Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the year ended December 31, 2014.
PPJ Healthcare Enterprises, Inc. (OTC Pink:PPJE) is seeking input from its shareholders on the company's continuing litigation against a Santa Clarita, Calif.-based physician and former PPJE board member.
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced positive results from a long-term analysis of more than three years of follow-up data from a Phase 2 study of its lead candidate, vonapanitase (formerly PRT-201).
Relypsa Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that data from a Phase 3 clinical program showing that Patiromer for Oral Suspension (Patiromer FOS), the Company's lead product candidate, was effective in reducing potassium levels and preventing a recurrence of hyperkalemia in patients with advanced (stage 4-5) chronic kidney disease (CKD) receiving ongoing treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors were presented today as a poster at the National Kidney Foundation 2015 Spring Clinical Meeting.
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that four individual abstracts for Triferic have been selected by the National Kidney Foundation (NKF) for presentation at their Spring Clinical Meetings, March 26-29, 2015 at the Gaylord Texan in Dallas, Texas.
Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced that it has scheduled an Investor conference call for 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.
Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP), a global biopharmaceutical company, today announced the pricing of an underwritten public offering of 4,000,000 shares of its class A common stock by selling stockholders, offered at a price to the public of $14.00 per share for an aggregate offering of $56.0 million of class A common stock.
WaferGen Bio-systems, Inc. (Nasdaq:WGBS) announced today an important industrial partnership with Procter & Gamble whereby Procter & Gamble will utilize WaferGen's SmartChip MyDesign™ quantitative PCR System to conduct various gene expression and other studies.
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, announced today that dosing has begun in patients enrolled in its Relday™ multi-dose Phase 1b clinical study.