VITAL SIGNS: Last October a team of researchers at Loyola University Medical Center began tracking how Facebook was being used as a tool for connecting potential donors with those in need of an organ. Image: Courtesy of uchar, via iStockphoto.com

Since launching in February 2004, Facebook has proved highly effective at creating opportunities for the average Web user to create campaigns that reach a mass audience. Most recently such opportunities have extended to organ donation, an area that could benefit from the social network's attention—controversy over its recent initial public offering aside, Facebook's membership is more than 900 million and growing.

Indeed, with demand for healthy organs for transplantation growing worldwide, Facebook has already become a popular channel for people soliciting kidneys, livers and other potentially lifesaving organs. Earlier this month the social network began offering members the ability to identify themselves as organ donors on their Facebook pages and to locate state organ-donation registries if they would like to become donors.

Last October a team of researchers at Loyola University Medical Center began tracking how Facebook was being used as a tool for connecting potential donors with those in need of an organ. The researchers focused on kidney solicitations in particular and studied 91 Facebook pages seeking kidney donations for patients ranging in age from two to 69. Of the Facebook pages studied, 12 percent reported receiving a kidney transplant and 30 percent reported that potential donors had stepped forward to be tested to determine whether they were compatible, the researchers recently reported at a meeting of the National Kidney Foundation. One page reported that more than 600 people had been tested as potential donors for a young child.

There was a broad range in terms of how much personal information people disclosed. Some Facebook pages simply asked people to donate, without providing any other information. Other pages provided great detail about patients who needed kidneys, including explicit medical histories and family photos as well as emotional accounts of hospital stays, emergency room visits, financial problems and the difficulties of living on dialysis, according to the researchers led by Alexander Chang, nephrology fellow at Loyola University Chicago Stritch School of Medicine.

The research findings also raised ethical concerns: 3 percent of the pages received offers to sell kidneys, mostly from people in Third World countries. Would-be donors typically asked for $30,000 to $40,000, even though selling organs is illegal in most countries. In addition, only 5 percent of pages mentioned the risks of kidney donation (such as possible internal bleeding and/or infection as a result of the surgery) and only 11 percent mentioned associated costs.

Scientific American interviewed Chang to find out more about his team's reasons for examining Facebook as a means of soliciting kidney donations, the potential impact that social networks could have on the organ-donation shortfall and the possible dangers posed by using Facebook to match those in need of an organ transplant with potential donors.

[An edited transcript of the interview follows.]

What inspired you to study social media—Facebook, in particular—as means for soliciting living kidney donors?
As a nephrology fellow, I became interested in this issue as the transplant waiting list continues to grow and is outpacing the donor pool (from both deceased and living kidneys). The only really growing segment of the donor pool is coming recently from donors not related to the patients receiving the kidneys, and it seemed to me that social media must be an extremely easy way for people to search for kidney donors, as people are connected via Facebook to large numbers of friends, family and acquaintances they would not normally interact with in person or even by telephone or e-mail. As I could find no research on the subject, I thought it would be important to characterize what people are currently doing and how they are going about doing it.

Are you and your colleagues also looking at other organs (the liver, for example) being solicited via Facebook?
We specifically looked at kidney donors, as this is my interest as a nephrologist but also because the issues of kidney donation are quite unique, as living liver donations do not occur very often (and incur more risk to the donor) and bone marrow donations usually entail very little risk to the donors.

What was your process for searching Facebook for kidney donors?
We created a search on October 3rd, 2011, and looked for terms including "kidney donor," "need kidney," "kidney donation," "seeking kidney," "find kidney" and "kidney search." We found 131 pages in English. Of these pages, only 78 specified the purpose of finding a kidney for a specific person. We found an additional 13 pages that had the purpose of finding a kidney for someone, linked from these 78 pages, giving us a total of 91 pages for our study.

What conclusions can you draw at this time about how much Facebook use contributed to making successful solicitations?
Since these are just publicly accessible pages on Facebook, certainly this is just a snapshot of how people are using Facebook, as Facebook gives users the option of making pages "private," and people may also be sending messages directly to their friends via the social networking site. Such messages would not be included in our study. Since we only studied 91 pages, and our information was only derived from what was shared by the Facebook page to the public, this work should be considered hypothesis-generating.

...

HENDERSON, Nev., May 29, 2012 (BUSINESS WIRE) -- --RenaZorb showed superior phosphate-binding capacity in preclinical testing compared to currently marketed products

--The clinical study is designed to assess safety and phosphate-binding capacity of RenaZorb

Spectrum Pharmaceuticals (nasdaqgs:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb(R) (also referred to as SPI-014) in healthy volunteers. RenaZorb is a lanthanum-based nanotechnology compound with potent phosphate-binding properties.

"We are excited to announce the first human clinical study of RenaZorb, which we have initiated based on the promising research findings we have seen," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "Over 90% of patients with kidney failure use oral phosphate binders to prevent hyperphosphatemia, yet there is often poor compliance due to gastrointestinal (GI) intolerance and excessive pill burden associated with current therapies. Further, in vitro research has shown that RenaZorb has much higher phosphate-binding capacity than current products on the market. We believe this will allow us to provide the same amount of phosphate-binding capacity at a lower dose and smaller tablet size, thus improving patient compliance. Based on these and other product characteristics, we feel RenaZorb has the potential to offer increased patient benefit and look forward to the swift completion of Phase 1 testing and further progress of the program."

The double-blind, dose-ranging, Phase 1 study in healthy volunteers is designed to evaluate the safety and the phosphate-binding capacity of RenaZorb. The primary endpoint is capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing. Secondary endpoints are safety and tolerability along with measurements of serum lanthanum levels. The study is expected to enroll 32 healthy volunteers into four sequential dose cohorts of eight subjects each. Six subjects will be randomly assigned to receive RenaZorb and two subjects to receive placebo within each cohort. RenaZorb will be taken orally three times a day within 15 minutes after meals in all four cohorts (1500 mg/day, 3000 mg/day, 4500 mg/day and 6000 mg/day). Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after RenaZorb dosing.

About RenaZorb(R)

RenaZorb, or SPI-014, is formulated as an orally available tablet of lanthanum-based nanotechnology with highly potent phosphate-binding properties for the potential treatment of hyperphosphatemia (high phosphate levels in the blood) in patients with chronic kidney disease (CKD). Hyperphosphatemia in Stage 5 CKD, also known as end-stage renal disease (ESRD), can lead to significant bone disease (including pain and fractures), secondary hyperparathyroidism and cardiovascular disease, and is independently associated with increased mortality. Currently marketed therapies for treating hyperphosphatemia account for sales estimated at $1 billion worldwide and include binders that are polymer-based, lanthanum-based, and aluminum/calcium-based phosphate binders. According to the United States Renal Data System (USRDS), over the last 20 years, the number of patients with ESRD in the US has grown 4-fold. In 2009, there were an estimated 571,414 patients with ESRD.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV(R) (levoleucovorin) for Injection and ZEVALIN(R) (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, belinostat and apaziquone, in late-stage development and a diversified pipeline of novel drug candidates in earlier stages of development. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company's website at www.sppirx.com .

Forward Looking Statement - This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new applications to the FDA may not receive approval, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.(R), ZEVALIN(R), FUSILEV(R), and RenaZorb(R) are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

(C) 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

SOURCE: Spectrum Pharmaceuticals, Inc.

        
        Spectrum Pharmaceuticals, Inc. 
        Shiv Kapoor, 702-835-6300 
        Vice President, Strategic Planning & Investor Relations 
        
 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
 
        

Copyright Business Wire 2012

...

HENDERSON, Nev., May 29, 2012 (BUSINESS WIRE) -- --RenaZorb showed superior phosphate-binding capacity in preclinical testing compared to currently marketed products

--The clinical study is designed to assess safety and phosphate-binding capacity of RenaZorb

Spectrum Pharmaceuticals (nasdaqgs:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb(R) (also referred to as SPI-014) in healthy volunteers. RenaZorb is a lanthanum-based nanotechnology compound with potent phosphate-binding properties.

"We are excited to announce the first human clinical study of RenaZorb, which we have initiated based on the promising research findings we have seen," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "Over 90% of patients with kidney failure use oral phosphate binders to prevent hyperphosphatemia, yet there is often poor compliance due to gastrointestinal (GI) intolerance and excessive pill burden associated with current therapies. Further, in vitro research has shown that RenaZorb has much higher phosphate-binding capacity than current products on the market. We believe this will allow us to provide the same amount of phosphate-binding capacity at a lower dose and smaller tablet size, thus improving patient compliance. Based on these and other product characteristics, we feel RenaZorb has the potential to offer increased patient benefit and look forward to the swift completion of Phase 1 testing and further progress of the program."

The double-blind, dose-ranging, Phase 1 study in healthy volunteers is designed to evaluate the safety and the phosphate-binding capacity of RenaZorb. The primary endpoint is capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing. Secondary endpoints are safety and tolerability along with measurements of serum lanthanum levels. The study is expected to enroll 32 healthy volunteers into four sequential dose cohorts of eight subjects each. Six subjects will be randomly assigned to receive RenaZorb and two subjects to receive placebo within each cohort. RenaZorb will be taken orally three times a day within 15 minutes after meals in all four cohorts (1500 mg/day, 3000 mg/day, 4500 mg/day and 6000 mg/day). Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after RenaZorb dosing.

About RenaZorb(R)

RenaZorb, or SPI-014, is formulated as an orally available tablet of lanthanum-based nanotechnology with highly potent phosphate-binding properties for the potential treatment of hyperphosphatemia (high phosphate levels in the blood) in patients with chronic kidney disease (CKD). Hyperphosphatemia in Stage 5 CKD, also known as end-stage renal disease (ESRD), can lead to significant bone disease (including pain and fractures), secondary hyperparathyroidism and cardiovascular disease, and is independently associated with increased mortality. Currently marketed therapies for treating hyperphosphatemia account for sales estimated at $1 billion worldwide and include binders that are polymer-based, lanthanum-based, and aluminum/calcium-based phosphate binders. According to the United States Renal Data System (USRDS), over the last 20 years, the number of patients with ESRD in the US has grown 4-fold. In 2009, there were an estimated 571,414 patients with ESRD.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV(R) (levoleucovorin) for Injection and ZEVALIN(R) (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, belinostat and apaziquone, in late-stage development and a diversified pipeline of novel drug candidates in earlier stages of development. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company's website at www.sppirx.com .

Forward Looking Statement - This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new applications to the FDA may not receive approval, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.(R), ZEVALIN(R), FUSILEV(R), and RenaZorb(R) are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

(C) 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

SOURCE: Spectrum Pharmaceuticals, Inc.

        
        Spectrum Pharmaceuticals, Inc. 
        Shiv Kapoor, 702-835-6300 
        Vice President, Strategic Planning & Investor Relations 
        
 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
 
        

Copyright Business Wire 2012

...

PARIS—New data show that the severity of periodontitis is associated with arterial stiffness in patients with worsening chronic kidney disease (CKD).

The study by British researchers found that patients who had more severe periodontitis tended to have increased arterial stiffness.

“Increased arterial stiffness typically occurs with CKD and may alter cardiac structure and function and ultimately increase the risk of cardiovascular death, which is a significant cause of morbidity and mortality in patients with CKD,” Stephanie Stringer, MD, renal research fellow at the University Birmingham, said in an interview at the 49^th Congress of the European Renal Association-European Dialysis and Transplant Association.

“If we eventually show from our prospective observational study that periodontitis in CKD patients is a risk factor for cardiovascular disease and renal progression,” Dr. Stringer continued, “this would lead to the development of studies to test whether treatment of periodontitis alters renal and cardiovascular outcomes. Thus, it may be that interventions aimed at improving periodontal health may play an important role in reducing the cardiovascular burden in patients with progressive CKD.”

The researchers measured arterial stiffness noninvasively using carotid-femoral pulse wave velocity (PWV) in 198 CKD patients recruited into the prospective observational Renal Impairment In Secondary Care (RIISC) study.

Periodontitis is characterized by chronic, low-grade inflammation of the gums and occurs in about 15% of patients with CKD, but the prevalence varies widely depending upon the population studies and the classification of periodontitis used, Dr. Stringer said.  Although a lot of research has been done on inflammation in rheumatology and cardiology cohorts, limited data exist on the periodontal health of patients with CKD and how this might influence their outcomes.

Periodontal measurements were obtained on all teeth of all dentate patients, including interproximal measurements of periodontal pockets, recession and bleeding on probing.

The prevalence of normal periodontal health, gingivitis, periodontitis and edentulous were 3.8%, 10%, 65.4% and 13.7%, respectively. Of the subgroup with periodontitis, the condition was classified as mild in 79, moderate in 41, and severe in 18 patients.

The data showed that increasing periodontitis severity was significantly associated with increasing PWV.  PWV values in patients with mild, moderate and severe periodontitis were 9.48, 10.53, 11.35 m/sec, respectively.  

After adjusting for potential confounders, including gender, age, blood pressure, or estimated glomerular filtration rate (eGFR) in the three different periodontal severity groups, the findings remained statistically significant.

These results suggest that the severity of periodontal disease is related to arterial stiffness, an important determinant of cardiovascular risk.

Study co-author Khai Ping Ng, MD, also a renal research fellow at the University of Birmingham, said that the research team plans to follow the study cohort for 10 years to identify the determinants of progressive kidney disease and cardiovascular risk, and to examine whether periodontal disease is an important and potentially reversible factor.  “Such information will be meaningful for patients because we could then tell them that periodontitis does not just influence a surrogate measure like pulse wave velocity but that it could actually increase their risk of eventually ending up on dialysis or experiencing a heart attack or stroke.”

...