Ardelyx Reports Results from Phase 2a Clincial Trial Evaluating Tenapanor; ZIOPHARM Announces Initiation of Phase 1 Study of Ad-RTS-IL-12 Print E-mail
By Josh Gee   
Tuesday, 05 May 2015 18:40
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 5 2015.  
Ardelyx, Inc. (NASDAQ: ARDX), clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal, and metabolic diseases, today announced that a 154-patient Phase 2a clinical trial evaluating tenapanor in Stage 3 chronic kidney disease patients with type 2 diabetes mellitus and albuminuria did not meet the primary endpoint of decreasing the urinary albumin-creatinine ratio in tenapanor-treated patients compared to patients receiving placebo.
Ardelyx formed a partnership with AstraZeneca in October 2012 to develop and commercialize tenapanor. Tenapanor has been evaluated in over 1,000 subjects as part of 14 clinical trials in healthy volunteers and in patients with constipation-predominant irritable bowel syndrome (IBS-C), hyperphosphatemia and chronic kidney disease (CKD). With the completion of the CKD trial, Ardelyx and AstraZeneca are assessing the data from all the trials. Under the terms of the agreement, AstraZeneca is obligated to communicate to Ardelyx, on or before June 29, 2015, whether it will continue the development of tenapanor. Should AstraZeneca decide to pursue the development of only the IBS-C indication, Ardelyx will be entitled to a milestone payment of $10 million. Should AstraZeneca decide to pursue the development of any other indication or multiple indications, Ardelyx will be entitled to receive a $20 million milestone payment.
"We continue to work with AstraZeneca as they evaluate the data, and we are preparing for the continuation of the development of tenapanor under a variety of different scenarios," said Mike Raab, President and CEO. "We are preparing for an end of phase 2 meeting for IBS-C with the FDA scheduled to occur in June. Should AstraZeneca decide to return the program to us, we seek to be in a position to initiate a Phase 3 clinical program for tenapanor in IBS-C in the fourth quarter of 2015. Additionally, we intend to be prepared to continue the development of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis. We believe that tenapanor can be a best-in-class treatment for IBS-C and hyperphosphatemia and we hope to accelerate the development for these underserved conditions either independently or with AstraZeneca."
 
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ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the initiation of a Phase 1 study of Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive glioblastoma or Grade III malignant glioma, a form of brain cancer. Ad-RTS-hIL-12 is a novel gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response.  
The Phase 1 study is designed to examine a gene therapy treatment strategy for high grade gliomas with the goal of generating an anti tumor T cell immune response.  Eligible patients will be stratified to one of two groups, according to clinical indication for tumor resection. One group will undergo resection plus injection and the other group will undergo stereotactic injection. Ad-RTS-hIL-12 will be injected locally in the tumor lesion, with IL-12 expression levels tightly regulated by escalating doses of the oral activator ligand veledimex. This strategy makes it feasible to control the gene therapy in vivo and to lower or terminate IL-12 expression in the event of severe or unexpected toxicities. The primary objective of the study is to determine the safety and tolerability of a single intra tumoral Ad-RTS-hIL-12 injection plus escalating oral veledimex doses. Secondary Objectives are to determine the veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 and veledimex, and investigator assessment of response, including the tumor objective response rate and progression-free survival, and determine overall survival, among other measures.
The study is expected to enroll up to 72 subjects at up to 12 leading treatment centers. Among the centers expected to begin enrollment are the Stanford School of Medicine, Dana Farber/Brigham and Women's, the University of Chicago Pritzker School of Medicine, Cedars-Sinai/the David Geffen School of Medicine at the University of California, Los Angeles, and Northwestern Memorial Hospital.
"Recurrent or progressive glioblastoma and malignant glioma are associated with a particularly aggressive course and dismal prognosis," said Maciej S. Lesniak, MD, MHCM, Professor of Surgery and Neurology, Director, Neurosurgical Oncology, Director, Neuro-Oncology Research, University of Chicago Pritzker School of Medicine. "The current standard of care treatment is based on surgical resection, which is limited by the infiltrative nature of the disease and the lack of clear margins delimitating the tumor. Given the poor overall prognosis and lack of effective treatments, new therapeutic approaches are urgently needed. Ad-RTS-IL-12 has demonstrated very promising preclinical efficacy."
"Evidence that IL-12 is able to trigger innate and adaptive immunity and collapse tumor stroma supports its relevance as an important immunotherapeutic agent," said Nino Chiocca, MD, PhD, Harvey W. Cushing Professor of Neurosurgery, Department of Surgery, Harvard Medical School, Surgical Director, Center for Neuro-oncology, Dana-Farber Cancer Institute, Chairman, Neurosurgery, Brigham And Women's Hospital and Co-Director, Institute for the Neurosciences, Brigham And Women's Hospital. "The preclinical data shows that Ad-RTS-IL-12 gene therapy could be a highly promising novel treatment for GBM."
Also Tuesday:
3D Systems (NYSE:DDD) announced today it has entered into a reseller agreement with HK 3D, a leading supplier of 3D printers and additive manufacturing in the UK and Ireland.
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, announced today that it will present at the Bank of America Merrill Lynch 2015 Health Care Conference in Las Vegas, Nevada. 
 
Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, Cushing's disease and autoimmune and inflammatory diseases, today announced that clazakizumab, previously known as ALD518, met its primary endpoint in a follow-on Phase 2b, dose-ranging clinical trial in adults with moderate to severe rheumatoid arthritis who have experienced an inadequate response to TNF inhibitors.
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 commenced a proposed follow-on public offering of 3,000,000 shares of its common stock.
Alliqua BioMedical, Inc. (Nasdaq:ALQA), a provider of advanced wound care products, today announced plans to release first quarter of fiscal year 2015 financial results after market close on May 14th.
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Patent Application Serial No. 13/305,025 entitled, "Dopaminergic Neuronal Survival Promoting Factors and Uses Thereof."


AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company focused on the $1.6 billion peripheral nerve repair market, reported record revenue of $4.95 million for the first quarter ended March 31, 2015 compared to $3.14 million in the year-ago first quarter.
Bacterin International Holdings, Inc. (OTCQX:BONE), a leader in the development of allograft materials, today reported financial results for the first quarter ended March 31, 2015. The Company reported first quarter revenues of approximately $9.5 million and a net loss for the quarter of approximately $4.2 million, or ($0.62) per common share.
Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced that it will present results from a recent pig study evaluating the effect of its Bioabsorbable Cardiac Matrix (BCM) on the mechanics of the heart following a heart attack.
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that executives from BioCryst are scheduled to provide a corporate summary and update regarding the Company's clinical programs at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas on Tuesday, May 12, 2015 at 2:20 p.m. Pacific Time.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a global provider of life science research and clinical diagnostic products, announced financial results today for the first quarter ended March 31, 2015.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that it will report financial results for the first quarter ended March 31, 2015 before the market opens on Tuesday, May 12, 2015.
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 that the Company will host a conference call and live audio webcast on Tuesday, May 12, 2015, at 4:30 p.m. ET to report first quarter 2015 financial results and provide a corporate update.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three months ended March 31, 2015.
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that management will host a conference call and live webcast to discuss first quarter 2015 financial results and provide an update on each of its development programs on Tuesday, May 12th at 5:00 PM EDT.
ExamWorks Group, Inc. (NYSE: EXAM), a leading provider of independent medical examinations, peer reviews, bill reviews, Medicare compliance services, case management services, and other related services ("IME services"), today reported financial results for the first quarter of 2015. 
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer of affordable health plans, today announced its newest line of business, AgileHealthInsurance.com. 
Inovio Pharmaceuticals, Inc. (Nasdaq:INO), today closed its previously announced underwritten public offering of 10,925,000 shares of the Company's common stock, including 1,425,000 shares of common stock issued pursuant to the underwriter's exercise of its option, at the public offering price of $8.00 per share. The gross proceeds of this offering were $87.4 million.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, announced today that it will report first quarter 2015 financial results on Monday, May 11, 2015.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that Greg Madison, the Company's Chief Executive Officer, will be presenting a company overview, including progress with the commercialization of Auryxia™ (ferric citrate) in the United States, at the Bank of America Merrill Lynch 2015 Health Care Conference, to be held at the Encore at the Wynn in Las Vegas, NV on May 12-14, 2015.

Mecox Lane Limited (Nasdaq:MCOX), a multi-brand and multi-channel retailer of health, beauty and lifestyle products in China, today announced the following changes to the Company's board of directors
Medipure Holdings Inc. (CSE:MDH) is pleased to announce that it has entered into a Memorandum of Understanding ("MOU") with France's Top Industrie to develop green technologies that will facilitate the implementation of Medipure's operational production platform.
MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced that the company will release the results for its first quarter ended March 31, 2015 before the market opens on Wednesday, May 13, 2015.
NeoStem, Inc. (Nasdaq:NBS), a biopharmaceutical company developing novel, cell-based individualized medicine therapies, announced today 2015 first quarter results and provided an update on its business.
OpGen, Inc. (Nasdaq:OPGN) today announced the pricing of its initial public offering of 2,850,000 units, with each unit consisting of one share of common stock and a warrant to purchase one share of common stock, at a combined price to the public of $6.00 per unit.
Portola Pharmaceuticals (Nasdaq:PTLA) today announced a collaboration with Ora, Inc. for the development of Portola's highly selective Syk inhibitor, PRT2761, in ophthalmic diseases.
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that William Lis, chief executive officer, will present at the Bank of America Merrill Lynch 2015 Health Care Conference on Tuesday, May 12, at 10:00 a.m. Pacific Time in Las Vegas.
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 it will present at the Bank of America Merrill Lynch 2015 Health Care Conference, being held at the Encore at the Wynn in Las Vegas, Nevada May 12-15, 2015.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported financial results for the first quarter of 2015 and associated company developments.
VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer, today announced that it will host a conference call and live audio webcast on Tuesday, May 12, 2015 at 8:30 a.m. ET to report first quarter 2015 financial results.

Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE), a clinical-stage biotechnology company, will host a conference call on Tuesday, May 12, 2015 at 4:30 p.m. EDT to discuss first quarter 2015 financial results and recent operational highlights. 
Vocera Communications, Inc. (NYSE:VCRA), the leading provider of real-time, intelligent communication solutions for mission-critical healthcare environments, today announced that two company executives have been recognized for their professional accomplishments and influence in healthcare and technology.
WaferGen Bio-systems, Inc. (Nasdaq:WGBS) announced today that it will announce first quarter ended March 31, 2015 financial results after the market close and host a conference call and webcast on Monday, May 11, 2015.
ZELTIQ®, (NASDAQ: ZLTQ) a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced financial results for the first quarter 2015.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that it will host a conference call on Tuesday, May 12, 2015 at 4:30 p.m. ET to discuss its financial results for the first quarter ended March 31, 2015.



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