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Rockwell Medical Completes Patient Enrollment in CRUISE-1 Phase III Clinical Study - Healthcare Global (press release) PDF Print

WIXOM, MI--(Marketwire - May 31, 2012) - Rockwell Medical (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 deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has completed patient enrollment in its pivotal Phase III CRUISE-1 clinical study, designed to provide iron-delivery to hemodialysis-dependent CKD patients.

Robert L. Chioini, Chairman and CEO of Rockwell, stated, "We are excited to have achieved this important milestone, which moves us closer to completing our SFP clinical development. We remain on track to meet our clinical development timeline for SFP, a product which upon FDA approval has the potential to transform the iron therapy market for dialysis patients."

Rockwell is conducting two pivotal Phase III clinical trials for SFP called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, placebo-controlled, multicenter study designed to demonstrate efficacy and safety of SFP-iron, delivered via dialysate, in adult CKD patients requiring hemodialysis. Each study will treat 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months. The primary efficacy end-point for both studies is the mean change in hemoglobin from baseline.

About Rockwell Medical:

Rockwell Medical is 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 deficiency, secondary hyperparathyroidism and hemodialysis. Rockwell's lead, late-stage investigational drug for iron therapy treatment is called SFP (soluble ferric pyrophosphate). SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. and $1B global market. Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism addresses a $350M U.S. market. 

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval. 

Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell's intention to launch Calcitriol and SFP following FDA approval. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical's SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

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High-Protein, Low-Carb Diet Safe for Kidneys - ABC News (blog) PDF Print

For decades, medical experts have been concerned that high-protein, low-carb diets like Atkins could be damaging to the kidneys, but a new study found that this isn’t the case in otherwise healthy patients.

Researchers from the Indiana University School of Medicine compared the effects of such a diet to that of a standard low-fat diet in 307 obese people who did not suffer from kidney disease or other chronic illnesses.

After a two-year period, they found that the high-protein, low-carb diet didn’t cause noticeable harmful effects on healthy obese patients’ kidney function compared to obese people who followed a low-fat diet.

“Despite decades of concerns about low-carb, high-protein diets that may cause kidney damage in healthy people, there were no signs that this would be the case after a 2-year period,” said Dr. Allon Friedman, lead author of the study, published in the Clinical Journal of the American Society of Nephrology.

Protein in the blood contributes to important protective benefits to the body, including fighting infections, blood clots and improving circulation in the body. Normally proteins are too big to pass through the kidneys’ filter into the urine, but proteins from the blood can leak into the urine when kidney filters are damaged, according to the NIH.

Abnormal amounts of protein in the urine, known as proteinuria, usually point to some sort of kidney disease, regardless of diet. But, researchers found that the most important way to reduce protein in urine did not have to do with the type of diet was the actual amount of weight lost, “not really how you get there,” Friedman said.

The results are relevant to the millions of healthy obese adults who use dieting as a weight-loss strategy, researchers noted. More than one-third of American adults are obese, according to the CDC.

Despite the promising results, Dr. Joseph Vassalotti, chief medical officer of the National Kidney Foundation, cautioned people to take the findings with a grain of salt.

“The population studied does not apply to most patients with or at risk for chronic kidney disease, since the study participants had no evidence of chronic kidney disease or other illnesses,” said Vassalotti.

“The best diet is obviously one that is balanced, that reduces calories and encourages daily exercise,” said Friedman. “For this study, we really showed that it’s not important how someone loses weight, but whether they can do it and keep it off.”

But Vassalotti added that the most “successful nutrition therapy will include a treating clinician, registered dietitian or certified diabetes educator and the patient to consider an individualized nutrition plan.”

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Mercy Malaysia Donates Dialysis Machine To Pakistan Hospital - Bernama PDF Print

June 01, 2012 20:26 PMimage

Mercy Malaysia Donates Dialysis Machine To Pakistan Hospital

KUALA LUMPUR, June 1 (Bernama) -- The Malaysian Medical Relief Society (Mercy Malaysia) donated a dialysis machine worth RM48,000 (USD$15,000) to Mirpukhas Civil Hospital in Pakistan Thursday, as part of its efforts to help reconstruct and rehabilitate health centres.

Mercy Malaysia vice-president Norazam Ab Samah said the Malaysian consul-general in Karachi, Abu Bakar Mamat, handed over the machine to the hospital's head of dialysis centre, Dr Tariq Arain.

"We also plan to rehabilitate a rural health centre in Tando Jan Muhammad, an area near Mirpurkhas," Norazam, who was present at the ceremony, said in a statement.

He said local contractors would be evaluated and selected by Mercy Malaysia's technical consultant for the tender process and provide technical consultation for the project during the entire recontruction period. Norazam said the Malaysian Government had donated RM3 million (about USD$1 million), to be utilised by Mercy Malaysia, for various projects in Sindh to alleviate the burden faced by the people there.

He said two mobile clinics set up in March, in collaboration with a local organisation, had so far provided consultation to more than 21,000 people.

In addition, Mercy Malaysia had distributed hygiene kits to more than 1,500 families this year, and begun projects of installing latrines, hand pumps and water filtration systems in villages in Sindh, said Norazam.

-- BERNAMA

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In Pune, fear keeps patients away from hospitals - Daily News Analysis PDF Print
Daily News & Analysis
A dialysis patient wanted to know if he could reschedule his appointment, a patient on physiotherapy wanted to know if he could get a free pick-up and a woman called to check if she would face any problem in reaching the hospital for her ante-natal

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Sayang Dialysis Franchise Helps Entrepreneurs And Patients - Bernama PDF Print

June 01, 2012 17:50 PMimage

Sayang Dialysis Franchise Helps Entrepreneurs And Patients

By Ahmad Shazwan Md Yusof

KUALA LUMPUR, June 1 (Bernama) -- Since franchising is one of the ways to fast track business development, Malaysia has introduced the National Franchise Development Master Plan (PIPFN) to help local businesses develop through franchises.

In fact, there are many franchise programmes at present, offering numerous ways to make money.

One unique franchise system involves running dialysis clinics for kidney failure patients, where the dialysis centre, instead of charging the patients, looks for sponsors to redeem the cost.

Sayang Dialysis is a franchise owned by Pakar Dialysis Traktif Sdn Bhd which provides dialysis treatment where the cost is reimbursed by the company through funds and sponsorships from welfare and philanthropic organisations such as Pusat Zakat.

The managing director of Sayang Dialysis, Shazali Shauf, told Bernama that "Looking at the dialysis patients, whose numbers have been increasing by about 10 per cent annually, we believe we could cater to their needs."

According to Shazali, the rising number of patients created the requirement for more dialysis machines, as one machine can only cater to six patients.

PIPFN'S BENEFITS

"The franchise programme serves as a springboard for us. We will be able to progress further. This has made it easier for us to conduct business.

"The franchise programme has helped us reorganise our business," Shazali remarked.

Therefore, the first Sayang Dialysis centre for public benefit was opened in Semenyih in March.

"That is not all; the company's development has also become more dynamic because of the assistance provided by the government through the Ministry of Domestic Trade, Consumerism and Cooperatives, which identifies how to reduce business risks and instil greater professionalism," he said.

Shazali acknowledged that the encouragement provided to franchisers and franchisees has been very helpful.

"For anyone interested in participating in a franchise, the franchisers will help by sharing their expertise for a fee of seven percent imposed for the first five years.

"After that, the franchise holder is free to continue with the franchise or switch to a new name," he explained, adding that he has plans to open up three more Sayang Dialysis franchises - one each in Temerloh, Johor and Rawang.

SOCIAL SERVICE

According to Shazali, Sayang Dialysis not only provides services to kidney patients but also gives them the avenue to meet and share their problems.

"Other than undergoing dialysis, patients also get to know one another, and this provides them some comfort," said Shazali, who started Sayang Dialysis with the help of a close friend.

Sayang Dialysis also helps patients learn more about their disease and enhances their self-esteem.

"This is part of our efforts to help those in a difficult situation," Shazali pointed out.

LONG-TERM PLANNING

Shazali next wants to open an educational institution known as Institut Traktif.

"That's not all; our long-term plan is to set up a tertiary institute like Institut Jantung Negara (IJN) for kidney diseases. This is because the number of kidney patients is rising every year, and this calls for a highly specialised hospital where one can get the best treatment.

"This may sound like a grandiose idea to some, but to me, it is not impossible to achieve. All this is part of the social service that we are trying to offer to society, through the assistance of PIPFN," he noted, adding that success is not easily obtained.

"With more clinics under the Sayang Dialysis franchise, we hope to strengthen the company's branding, apart from opening these avenues to other entrepreneurs," Shazali added.

-- BERNAMA

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