月別アーカイブ: 2014年5月

ZS Pharma to Present Data from Phase 3 Trial of ZS-9 in Late-Breaking Poster Presentation at the European Renal …

COPPELL, Texas–(BUSINESS WIRE)–

ZS Pharma, a biopharmaceutical company developing novel treatments for
kidney, cardiovascular, liver and metabolic disorders, today announced
that data from a pivotal Phase 3 trial of ZS-9, its investigational
treatment for hyperkalemia, will be presented as a late-breaking
clinical trials poster presentation during the 51st European
Renal Association-European Dialysis and Transplant Association
(ERA-EDTA) Congress being held in Amsterdam from May 31 to June 3, 2014.

The Company’s Phase 3 trial, ZS003, assessed the safety and efficacy of
ZS-9 in treating patients with hyperkalemia, a life-threatening
condition that is characterized by higher than normal levels of
potassium (K+) in the blood serum. To date, Phase 2 and Phase 3 clinical
trials of ZS-9 have demonstrated significant, rapid and sustainable
reductions in serum potassium with a safety profile similar to placebo.
Results demonstrated that both the 5g and 10g doses of ZS-9,
administered once daily, controlled potassium at normal levels in
hyperkalemic patients.

Late-Breaking Poster Presentation

ZS-9 Once-Daily Consistently Maintained Normokalaemia Across
Subgroups in a Phase 3 Multicenter, Randomised, Double-Blind,
Placebo-Controlled Trial of Patients with Hyperkalaemia

 
Presenter:   David K. Packham, MB, BS, MD, MRCP, FRACP, Melbourne Renal Research
Group, Royal Melbourne Hospital, Australia
Session: Late-Breaking Clinical Trials, Poster MP758
Date: Monday, June 2, 7:30 – 10:45 a.m. CEST
 

Poster Presentations

In addition to the late-breaking poster presentation, data about
ZS-9 will be presented in seven posters during a Poster Session on
Sunday, June 1, from 7:30 – 10:45 a.m. CEST.
 
Poster SP320: Acute-Phase Efficacy in a Phase 3 Multicenter, Randomised,
Double-Blind, Placebo-Controlled Trial of ZS-9 in Patients with
Hyperkalaemia
Presenter: Mohamed A. El-Shahawy, MD, MPH, MHA, FASN, Clinical Professor of
Medicine, Keck-USC School of Medicine, Director, Academic Medical
Research Institute, Los Angeles, Calif., USA
 
Poster SP331: Extended Efficacy of ZS-9 Once-Daily in a Phase 3 Multicenter,
Randomised, Double-Blind, Placebo-Controlled Trial of Patients with
Hyperkalaemia
Presenter: Simon D. Roger, MD, FRACP, Department of Renal Medicine, Gosford
Hospital, Australia
 
Poster SP337: Safety and Tolerability of ZS-9 in a Multicenter, Randomised,
Double-Blind, Placebo-Controlled Trial in Patients with Hyperkalaemia
Presenter: David K. Packham, MD, MB, BS, MD, MRCP, FRACP, Melbourne Renal
Research Group, Royal Melbourne Hospital, Australia
 
Poster SP324: Efficacy of ZS-9 in Patients Receiving RAAS Therapy: A Subgroup
Analysis of a Phase 3 Multicenter, Randomised, Double-Blind,
Placebo-Controlled Trial
Presenter: Simon D. Roger, MD, FRACP, Department of Renal Medicine, Gosford
Hospital, Australia
 
Poster SP321: Phase 3, Multicenter, Randomised, Double-Blind, Placebo-Controlled
Trial of ZS-9: Acute Efficacy by Baseline Serum Potassium Levels
Presenter: Bhupinder Singh, MD, Assistant Clinical Professor, Department of
Medicine, Creighton University School of Medicine, and Chief Medical
Officer, Apex Research of Riverside, Calif., USA
 
Poster SP001: Optimizing the ZS-9 Potassium Ion Trap: Pore Size and Thermodynamics
Presenter: Alex Yang, MD, Xelay Acumen, Belmont, Calif., USA
 
Poster SP251: Acid-Base Balance in Phase 2 and Phase 3 Trials of ZS-9 for
Hyperkalaemia for Hyperkalaemia in Patients with Chronic Kidney
Disease
Presenter: Bhupinder Singh, MD, Assistant Clinical Professor, Department of
Medicine, Creighton University School of Medicine, and Chief Medical
Officer, Apex Research of Riverside, Calif., USA

About ZS-9’s Clinical Development Program
The ZS-9 clinical
program is designed to investigate the treatment of acute and chronic
hyperkalemia, regardless of underlying cause. ZS Pharma recently
completed a 753-patient Phase 3 study, ZS003, which showed that ZS-9
rapidly reduced serum potassium in hyperkalemic patients to normal
levels within the 48 hour Induction Phase and then controlled potassium
in the normal range throughout the 12 day Extended Treatment Phase. In
addition, the study provided evidence suggesting that ZS-9 is safe and
well-tolerated with an adverse event profile similar to placebo.

In 2014, ZS Pharma initiated ZS004, its second Phase 3 clinical trial of
ZS-9. ZS004 is a randomized, double-blind, placebo-controlled study
designed to confirm, over a longer treatment period, the positive
results previously reported for ZS003. In addition to ZS004, the Company
plans to initiate an additional long-term safety study, ZS005, in the
second quarter of 2014, and plans to file a New Drug Application with
the United States Food and Drug Administration and a Marketing
Authorization Application with the European Medicines Agency in the
first half of 2015.

About Hyperkalemia
Hyperkalemia, or higher than normal
potassium levels (typically defined as a serum potassium level >5
mEq/L), is a life-threatening metabolic condition that can lead to
cardiac arrhythmia and sudden cardiac death. Hyperkalemia is
characterized by abnormally high concentrations of potassium in the
blood resulting from the inability of the kidneys to excrete potassium,
impairment of mechanisms that transport potassium into cells, or a
combination of both factors. The causes of hyperkalemia vary but the
most common are chronic kidney disease (CKD), diabetes, congestive heart
failure (CHF) and side effects from cardio-renal protective drug
therapy, such as renin angiotensin aldosterone system (RAAS) inhibitors.

About ZS Pharma
ZS Pharma is a privately-held, specialty
pharmaceutical company based in Coppell, Texas. ZS Pharma’s lead
therapeutic candidate, ZS-9, is an investigational treatment for
hyperkalemia that is being evaluated in late-stage clinical trials to
demonstrate its ability to safely and effectively remove excess
potassium from the blood and maintain normal potassium levels. ZS Pharma
is also pursuing the discovery of additional drug candidates that
utilize its novel selective ion-trap technology for the treatment of
kidney and liver diseases. Additional information is available at www.zspharma.com.

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ZS Pharma to Present Data from Phase 3 Trial of ZS-9 in Late-Breaking Poster Presentation at the European Renal …
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Pharmacist makes house call, finds man on floor

RAMONA, Calif. – A Ramona pharmacist had a gut feeling something was wrong when one of his patients did not pick up his medication. He was right.

Murray Frankel, 88, is described as an expert mechanic and a jokester.

“He loved to tell people jokes. He would stop people on the streets, total strangers,” said his son, Gary Frankel.

Frankel also loved yard sales.

“He was here with his dog ‘Yard Sale’ that he got at a yard sale,” his son added.

John Robertson was Murray Frankel’s pharmacist. About four weeks ago, on a Saturday night, he did something very unusual after Frankel could not pick up his medication.

“I dropped it off at his house and we hung out for maybe an hour and just got to know each other,” said Robertson.

He had dropped off just an emergency 72-hour supply of medication.

“We’re about taking care of people and making sure that their safety is our primary concern,” said Robertson.

Frankel would need to pick up the rest of the medication on Monday. But when Robertson called to check on him, he said Frankel did not respond to any of his calls.

“I called him probably four or five times,” said Robertson.

When Frankel did not pick up his prescriptions, Robertson went to his house.

“Tuesday morning, I woke and kind of out of the ordinary I said, ‘Look, I have to go check on this guy,’” said Robertson.

He knocked on the door but no one answered and all he saw was the Sunday newspaper.

“The fact that it’s a Sunday paper … it’s Tuesday morning,” said Robertson.

Robertson and a neighbor looked around the property then called the police.

“The police did a forced entry and that’s when they found him,” said Robertson.

Frankel suffered a stroke and was taken to the hospital. His son came down from Seattle when he received the news.

Unfortunately, Frankel passed away three weeks later. His family is grateful Robertson found him and that Frankel was surrounded by those he loved in his final moments.        

“I think it’s extraordinary that he would make the effort and come all the way out here and check on a customer,” said Gary Frankel.

On Wednesday, Robertson was honored for going above and beyond the call of duty by the California Pharmacy Board.

Robertson tells 10News he would do it again and hopes others pharmacists would do the same.

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Pharmacist makes house call, finds man on floor
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Pharmacist honored for saving patient









RAMONA — Pharmacists don’t typically make house calls, but John Robertson isn’t your typical pharmacist.

The 30-year-old pharmacist at the Sav-On in Ramona was recognized by a state medical board Wednesday for going above and beyond his duties to rescue a patient.

“I’ve always gotten the strong sense that when we live in a community, one of our primary goals as a community member is to watch out for each other,” he said.
In April, the Ramona native met 88-year-old Murray Frankel.

Frankel needed an emergency refill of his medication to get him through the weekend, but there were some issues with his insurance so Robertson personally delivered the medication to his house that night. It was there the two men got to know each other.

“He makes a lot of different steam engines out of pretty much nothing. Like old parts. And he’s able to manufacture them by himself,” Robertson said.

Robertson knew the 88-year-old only had enough medication to last the weekend, so when Monday rolled around and he couldn’t reach Frankel, he got worried.

After trying to call four or five times Monday, Robertson decided to drive to Frankel’s house Tuesday morning to check up on him.

Frankel had suffered a stroke and had collapsed inside the home, unable to move, according to his son Gary Frankel.

“I think it’s extraordinary that he would make the effort to come all the way out here to check on a customer,” Gary Frankel said. “Who would have thought a pharmacist would even know the name of a customer, let alone think, ‘Well, where’s Murray been for the last couple of days?’”

On Wednesday, The California State Board of Pharmacy gave Robertson a special commendation. While receiving the award, Robertson got word his girlfriend had gone into labor with his first child.

Frankel’s son said his father, who loved scouring yard sales for broken items to fix so much he named his dog “Yardsale,” spent about 3 weeks in the hospital and improved enough to be discharged. But last week his health quickly faded.

“He basically, just in the course of a few days, declined to where he passed away quite suddenly and unexpectedly,” he said.

Still, he said he’s grateful for the extra time his father was able to get. All because of the pharmacist who made house calls.







Source Article from http://www.sandiego6.com/news/local/Pharmacist-honored-for-saving-patient-261018751.html
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