PLEASE READ , BY DR. O. IMPORTANT

[obsidianom]

PLEASE READ MY PREVIOUS 6 POSTS ON THE PAGE BEFORE THIS BEFORE YOU READ THIS.!

THIS IS ABOUT TRIFERIC THE DRUG TESTED IN CENTER ON SOME OF YOU AND NOW TO BE RELEASED TO USE ON YOU!!!!
SFP IS TRIFERIC!! 

Yocum alleged in his suit that Rockwel Medical:
 
–falsely claimed that the results of its earlier Phase IIb studies of SFP were positive, despite the fact that they failed to demonstrate that the treatment was effective.

 “Essentially, except for showing an absence of safety issues, the study was a failure,’’ the complaint said.
 
Yocum said in the suit that he and other experts warned Chioini that the results of the study did not provide enough data on efficacy or dosing to proceed directly to Phase III clinical trials.
 
The company nevertheless issued a press release on Feb. 25, 2010 that was headlined “Rockwell Announces Positive Phase IIb Clinical Data.” The release said the study “met its objective of determining the dosing of SFP for the planned Phase III trials.’’

[obsidianom]

Rockwell hopes to generate hundreds of millions of dollars on Triferic. I read thier plan . They hope to put this in the dialysate in centers and they beleive it will cut the amount of EPO needed.
This should scare EVERY dialysis patient. If the clinics can cut EPO they would save money based on the medicare bundling of payments. There will be an economic push to make this work at OUR expense. WATCH OUT!   Triferic will replace EPO is the Rockwell plan. The only problemis ,----It may not work at all according to their original researcher who was fired for speaking the truth.   All dialyis patients will be guinea pigs potentially in this hundreds millions  dollars gamble. If it fails to work ANEMIA may make a comeback . EPO is expensive. What do you all think will occur??

[Speedy1wrc]

Here you go talking about me and I didn't even know this thread was here. Lol.

The issues:

Patients exhibited high aluminum levels as far back as March of 2013. Efforts were made to determine the cause, of which none was found on the patient side. This WAS reported to NxStage although their recall statement indicates the contrary. NxStage categorically stated that it could not be from the dialysate. Dialysate with high aluminum was discovered and a recall was issued.

As patients and caregivers we are outraged that we were exposed to the high aluminum, and for the extended period of time. Many of us have been experiencing symptoms for quite a long time and are also concerned about long term harm. All we have gotten from NxStage is a "sorry for the inconvenience". That is not acceptable.

Dr O has been following upon the trail of evidence. We all should be doing are own digging and research. Strength in numbers. We all need to push NxStage to come clean and put procedures in place to ensure this can't happen again. We need to know if this is the extent of the problem or it is bigger than what we have been told. Being when I started with high levels I strongly suspect we have only seen the tip of the iceburg.

I have calls in to Rockwell and NxStage.  My expectations are low, but I am trying to get more information. We'll see.

[KarenInWA]

So does this mean that dialysis patients across the country have been unknowingly participating in a drug study with Triferic being added to their dialysate? Isn't that illegal? Or, is there something in the paperwork we all sign saying that we are okay with being drug company guiniea pigs? Usually when one participates in a drug study, one gets compensated. How have these tens of thousands or hundreds of thousands of patients been compensated for being a drug trial guniniea pig??? And, how is it "legal" to force those who have to undergo life saving treatment to "participate" in a drug trial??? Am I reading this right? Where is the OUTRAGE???

 

KarenInWA

[Speedy1wrc]

Being HHD that aspect doesn't apply to me, but it certainly caught my attention for the same concerns you expressed. I am curious if it may start to apply to dialysate provided outside of center.

No lack of outrage over how dialysis patients have become profit centers as opposed to being people though.

[obsidianom]

Rockwell's lead drug candidate Triferic™ is in late-stage clinical development for the treatment of iron replacement in dialysis patients. Triferic™ delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose. Triferic™ has successfully completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). Triferic™ is expected to address an estimated $600M U.S. market

[obsidianom]

Read this. It shows the GRAND PLAN of Rockwell is to see the clinics cut the EPO dose to save money to the clinics. You all could be effected.



Primary Endpoint

The primary objective of the study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery.  The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period).  Baseline ESA dose was similar between SFP (9448 U/wk) and placebo (9049 U/wk). In the modified ITT population, at the end of the study, ESA dose in the SFP arm was 10557 U/wk and placebo was 13345 U/wk. After adjusting for differences in baseline hemoglobin, the SFP arm required 37.1% less ESA dose compared to placebo. The difference between the two groups was statistically significant (p=0.034). The ESA sparing effect from SFP was observed without an increase in serum ferritin or transferrin saturation.  A total of 32 patients received rescue IV iron, 20 in placebo and 12 in SFP. Further analysis of the complete data set is ongoing and the Company plans to submit PRIME data results for presentation at a major medical meeting later in 2013.

Dr. Raymond Pratt, Chief Medical Officer of Rockwell Medical stated, "We are very excited about the results of this well-run study.  The 11 microgram/dL SFP dose delivered sufficient iron without increasing iron stores while greatly reducing ESA dose. The safety profile of SFP was similar to placebo and was well tolerated.  In this study, a 37% higher ESA dose was needed in the placebo arm to maintain hemoglobin compared to the SFP arm, but in the Phase 3 CRUISE efficacy studies the ESA dose is kept constant, unable to be titrated, over the 12-month study period.  The PRIME results support our belief that SFP will demonstrate efficacy in the Phase 3 CRUISE clinical studies by maintaining hemoglobin in the SFP arm while hemoglobin decreases in the placebo arm." 

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are extremely pleased with the results of the PRIME study.  We believe that SFP's unique ability to treat iron deficiency while dramatically reducing the need for ESA, without increasing iron stores, strengthens SFP's potential to become the market leading iron therapy treatment for CKD-HD patients.  SFP's ability to substantially reduce ESA use in the treatment of anemia should translate into significant cost savings in dialysis care while potentially lowering the serious risks associated with the dosing of ESAs. We sincerely thank the study investigators and coordinators, and our clinical team for a well-conducted PRIME study, and we look forward to the upcoming efficacy results from the Phase 3 CRUISE studies, which are expected to read-out in the 2nd-half of this year."

[Speedy1wrc]

I work with numbers all the time being an engineer and know that presenting data you can make anything sound good or bad with the same dataset. Also, phrases like well tolerated are pretty iffy. There is no love with statisticians and engineers. Give me the raw data and let me make my own conclusions. Adjustments and numerical correlations just muddy the waters

[obsidianom]

The "raw data" seems to show AT BEST" they were able to reduce the amount of EPO by a small amount. On the average the patients went from 13,000 units  down to 10, 000 units. Woopee.  All that money and extra work in the dialysate and thats all they could do? I  am NOT inpressed.  They staked a lot of money and debt in to this .

[obsidianom]

MORE OURSIDE ANALYSIS ON ROCKWELL MEDICAL AND THEIR DRUG TRIFERIC


What You Need to Know About or Be Warned About Rockwell Medical?
 
Brean Capital analyst Jonathan Aschoff initiated coverage on Rockwell Medical with a sell plus he commented that:
 

“Triferic did not appear to reduce total ESA use versus placebo in the PRIME trial, and did not reduce ESA use versus baseline, by contrast to what is seen with IV iron and Zerenex. The CRUISE trials had a questionable design that we view as unlikely to result in approval. Both CRUISE trials did not allow IV iron use or changes in ESA use, which is utterly inconsistent with current dialysis center practice under bundled reimbursement. More than 80% of the patients in all CRUISE arms did not complete the 48-week treatment period, making the primary endpoint evaluation period (defined as the last 1/6 of time on treatment) highly variable among patients. A key employee termination and resulting lawsuit further speaks to inadequate Triferic testing, in our view, where a former VP of Drug Development and Medical Affairs warned Rockwell that its Phase 2b trial did not adequately show efficacy or dose-ranging information to proceed directly to Phase 3."
 
Sales of Rockwell’s drugs have been stagnant ($60 million, $49 million, and $50 million in 2010, 2011, and 2012, respectively) and we project flat future growth."
 
A look at Rockwell Medical’s financials does show flat revenues of $49.84M (2012), $48.97M (2011), $59.55M (2010) and $54.73M (2009) for the past four years along with increasingly large net losses of $54.02M (2012), $21.44M (2011), $2.68M (2010) and $5.50M (2009) plus $31.22M in cash and short term investments to cover $18.07M in current liabilities and $19.43M in long term debt. Those financials are something investors should consider but of course FDA approval of Triferic would change all of that (Note: Stifel Nicolaus analyst Annabel Samimy says annual sales of Triferic could reach $200 million a year).