Protein-bound uremic toxin lowering effects of sevelamer in end-stage kidney disease receiving hemodialysis with hyperphosphatemia: a randomized controlled trial

Start Date01 Jun 2023

Sponsor / Collaborator

University of Chulalongkorn

[+1]

IRCT20200724048193N1 / CompletedPhase 4

Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of hs-CRP, Soluable CD-14 and Endotoxin in Hemodialysis Patients

Start Date22 Oct 2020

Sponsor / Collaborator

Tabriz University of Medical Sciences

NCT03451019 / CompletedPhase 4IIT

Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease

Sevelamer hydrochloride (SE) can increase intestinal calcium absorption in contrast to lanthanum carbonate (LA). Study compared effect of LA and SE on serum and urine phosphate and calcium, and hormones regulating mineral-bone metabolism.

Start Date01 Mar 2018

Sponsor / Collaborator

Medical University of Lodz

[+1]

100 Clinical Results associated with Sevelamer Hydrochloride

100 Translational Medicine associated with Sevelamer Hydrochloride

100 Patents (Medical) associated with Sevelamer Hydrochloride

364

Literatures (Medical) associated with Sevelamer Hydrochloride

01 Mar 2024·Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis

Biochemical markers of iron status and iron accumulation in peritoneal dialysis patients treated with ferric citrate

Article

Author: Lea, Janice I ; Ajiboye, Oyintayo ; Navarrete, José E

Background::

Hyperphosphataemia is a common complication of kidney disease. Current dialysis techniques do not provide enough phosphorus clearance, hence the need to use phosphorus binders. Treatment options include calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer hydrochloride and iron-based binders. Patients receiving peritoneal dialysis (PD) with sustained elevated ferritin levels exceeding 800 ng/mL are at a higher risk of death. We identify PD patients treated with iron-based binders and compare ferritin and risk of iron accumulation to patients treated with non-iron-based binders.

Methods::

All records of patients receiving PD at Emory dialysis centres until 30 October 2021 were reviewed for phosphorus binders. Basic demographics and laboratory data were time-referenced to the days on treatment with a particular binder. Patients were followed until discontinuation of the phosphorus binder, death, transplant, transfer to another dialysis provider or censoring at 36 months after medication was started.

Results::

Compared to calcium acetate and sevelamer, ferric citrate utilisation in PD patients resulted in a sustained increase in ferritin. The proportion of patients with a ferritin equal to or greater than 800 ng/dL and transferrin saturation greater than 40% increased over time in patients treated with ferric citrate and was higher during the second and third year of follow-up compared to baseline values and to patients treated with calcium acetate or sevelamer. Two patients (7%) treated with ferric citrate developed clinically significant haemosiderosis.

Conclusions::

Use of ferric citrated in PD resulted in significant iron accumulation as judged by ferritin levels.

01 Oct 2023·Endocrinology, diabetes & metabolism case reports

Elderly-onset calcinosis of hyperphosphataemic familial tumoural calcinosis/hyperostosis-hyperphosphataemia syndrome: the role of comorbid scleroderma

Article

Author: Iwasaki, Hiroaki

Summary:

A 73-year-old woman with type 2 diabetes mellitus was referred to our department for glycaemic control. Physical examination revealed two subcutaneous hard masses around the left shoulder and the right hip joint. The patient could not fully extend her fingers because of skin sclerosis in both hands. Laboratory studies showed hyperphosphataemia and a high ratio of renal tubular maximum reabsorption of phosphate to glomerular filtration rate. There were no abnormalities in serum calcium, creatinine, alkaline phosphatase, and intact parathyroid hormone levels, whereas serum fibroblast growth factor 23 was low. Hyperphosphataemic familial tumoural calcinosis/hyperostosis-hyperphosphataemia syndrome (HFTC/HHS) was diagnosed using whole genome sequencing that revealed a novel frameshift beyond the 584th threonine located in the lectin domain of UDP-N-acetyl-alpha-D-galactosamine:polypeptide N-acetylgalactosaminyltransferase 3 associated with a duplication of the 1748th thymine in the coding region of the corresponding gene. Furthermore, anti-nuclear, anti-centromere, and anti-cardiolipin antibodies were positive, implying that comorbid limited type scleroderma might play a role in tumoural calcinosis (TC) development. A low phosphate diet was prescribed with phosphate-lowering medications, including aluminium hydroxide, acetazolamide, and sevelamer hydrochloride. The patient displayed a decrease in serum phosphate levels from 6.5 to 5.5 mg/dL 10 months after the initiation of treatment, but her TC had not improved during treatment for more than 1 year. This case was interesting because the patient with HFTC/HHS exhibited TC despite being over her 60s, and subsequent scleroderma might contribute to the specific clinical course. When HFTC/HHS presents with elderly-onset TC, the involvement of comorbidities in exacerbating TC should be considered.

Learning points:

HFTC/HHS occurs on an autosomal recessive basis, but its clinical course and manifestations differ significantly throughout the cases.HFTC/HHS may be undiagnosed until later in life because of its rarity, unfamiliarity, and phenotype diversity; therefore, HFTC/HHS should be included in the differential diagnosis of elderly patients with unexplained hyperphosphataemia or ectopic calcinosis.Comorbidities, including rheumatologic disorders, may contribute to developing HFTC/HHS-associated calcinosis.

04 Jul 2023·Drug and chemical toxicology

In vitro cytogenetic analysis of two different anti-phosphates (sevelamer hydrochloride and calcium carbonate) agents used by patients with hyperphosphatemia

Article

Author: İla, Hasan Basri ; Ulaya, Goulzar

Sevelamer hydrochloride (SH) and calcium carbonate (CaCO₃) are two agents included in the phosphate-binding group which are frequently prescribed in the treatment of patients with hyperphosphatemia. However, there are no satisfactory studies on the genotoxic effects of SH in vitro. This study was conducted to reveal the genotoxic and/or cytotoxic potential of these two drugs in cultured human peripheral lymphocytes. Human peripheral lymphocytes were treated with SH and CaCO₃ at sublethal concentrations for 24 or 48 h for micronucleus assay and 1 h in the comet assay. CaCO₃ and SH stimulated a slight increase in micronucleus formation however this increase was not significant compared to the control group. According to the findings of the comet test, only one concentration of the SH caused significant DNA damage (2 mg/ml, 48 h) whereas CaCO₃ did not cause important DNA breakage. No significant oxidative damage or anti-radical effect caused by test substances was observed on the pure pBR322 plasmid DNA in a cell-free medium. Also, it was found that the drugs were devoid of mutagenic activity in the Ames test, but had a weak cytotoxic effect. Both test substances, particularly SH, significantly reduced the nuclear division index compared to the control group. In conclusion, the cytotoxic effect of SH was evident on the basis of in vitro tests and slightly higher than CaCO₃.

News (Medical) associated with Sevelamer Hydrochloride

03 Nov 2023

·www.globenewswire.com

Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023

WALTHAM, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today shared positive data on the use of XPHOZAH® (tenapanor) in poster presentations at the American Society of Nephrology (ASN) Kidney Week 2023 meeting, currently being held in Philadelphia, Pennsylvania, and will showcase XPHOZAH in an Exhibitor Spotlight event. Ardelyx’s presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease. XPHOZAH, the first and only phosphate absorption inhibitor, was approved by the U.S. Food and Drug Administration on October 17, 2023 to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. “We are thrilled to share compelling data highlighting why XPHOZAH, with its differentiated blocking mechanism, may benefit patients who have hyperphosphatemia despite ongoing treatments with currently available therapies,” said Laura Williams, M.D., M.P.H., Chief Medical Officer at Ardelyx. “The data being presented at ASN Kidney Week 2023 highlight why we are enthusiastic to bring this medication to patients who struggle to achieve target treatment goals and to their healthcare providers who are in need of a new treatment option.” The first poster, titled Optimal Initiation of Tenapanor Treatment Analyzed by Baseline Phosphate Binder Dose: A Sub-analysis of the OPTIMIZE Study, looked at serum phosphate (sP) control across two cohorts of patients by phosphate lowering pill burden. In OPTIMIZE, Cohort 1 added tenapanor 30 mg twice a day and stopped using phosphate binders, while Cohort 2 added tenapanor 30 mg twice a day and reduced their phosphate binder dose by ≥50%. The OPTIMIZE study showed that both cohorts experienced improved sP control and improved patient reported quality of life, as well as a reduction in pill burden. This analysis suggests that patients on high phosphate binder dosage (more than six pills per day) may have better early sP control by initiating tenapanor with a 50% reduction in phosphate binder dosage, while patients on lower dosage of phosphate binders had similar early sP control regardless of the tenapanor initiation strategy. In a poster titled Patient Education Improves Adherence to Tenapanor Treatment in OPTIMIZE Study, researchers looked at the effect of patient education on adherence, using data from the OPTIMIZE study compared to data from two phase 3 clinical studies of tenapanor, BLOCK and PHREEDOM. In the OPTIMIZE study, patients were provided with a patient brochure including information on how to take tenapanor, what they might experience while on the medication, which medications should be discontinued and ways to mitigate potential onset of loose stools or diarrhea. The study found that this educational information improved adherence, and may have specifically reduced medication discontinuation due to changes in bowel habits. The third poster, Safety Analysis of Tenapanor Monotherapy vs Sevelamer Carbonate in Patients on Maintenance Dialysis with Hyperphosphatemia, reviewed patient data from the PHREEDOM study that evaluated tenapanor for the treatment of hyperphosphatemia in patients with CKD on maintenance dialysis. It aimed to compare adverse events between patients who received tenapanor 30 mg twice a day and patients in the safety population who received sevelamer per standard of care during a 26-week randomized treatment period. The study showed that a lower proportion of patients treated with tenapanor versus sevelamer experienced a serious adverse event (SAE) while the exposure adjusted rates were similar. This analysis also showed that the incidence of adverse events leading to hospitalization (also characterized as an SAE) was lower in the tenapanor arm than the sevelamer arm while the exposure adjusted rates were similar. The analysis concluded that tenapanor has an acceptable safety and tolerability profile in patients with CKD on maintenance dialysis. The final Ardelyx poster to be shared at ASN, Tenapanor in Combination with Phosphate Binders Improves Short and Long-Term Control of Serum Phosphate (sP) in Patients on Dialysis with Hyperphosphatemia (FR-PO318), will be available from 10:00am to 12:00pm ET on Friday, November 3, 2023. These poster presentations are publicly available and can be accessed on demand here. Additionally, Ardelyx is hosting an XPHOZAH Exhibitor Spotlight at ASN Kidney Week 2003. The session, titled A New Paradigm: Rethinking Hyperphosphatemia Management will be held at 11:00 AM on Friday, November 3, 2023 in Theater 2 in Exhibit Hall B of the Pennsylvania Convention Center. The Spotlight will be presented by Arnold Silva, MD, PhD. Director of Home and Peritoneal Dialysis Programs, Boise Kidney & Hypertension Institute, and by David Spiegel, MD, Vice President of Nephrology at Ardelyx. About XPHOZAH® (tenapanor)XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information. About HyperphosphatemiaHyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL). IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSXPHOZAH is contraindicated in: Pediatric patients under 6 years of agePatients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONSDiarrheaPatients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea. MOST COMMON ADVERSE REACTIONSDiarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials. INDICATIONXPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. For additional safety information, please see full Prescribing Information. About Ardelyx, Inc.Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) as well as early-stage pipeline candidates. Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin has received approval for PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook. Investor and Media Contacts: Caitlin Lowieclowie@ardelyx.com Kimia Keshtbod kkeshtbod@ardelyx.com

Clinical ResultDrug ApprovalPhase 3

06 Sep 2023

·www.biospace.com

Amneal Receives First Product Approval in China

1st product approval in China represents Amneal’s entry in second largest pharmaceutical market Expects international expansion will be another key vector for long-term growth and impact BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received its first product approval in China. Sevelamer carbonate was approved and is expected to launch shortly. In addition, the Company expects to launch oseltamivir phosphate in China this year as well, upon approval. In total, Amneal has 6 products pending review in China with more product registrations planned over time. Since 2019, the Company has collaborated with Fosun Pharmaceuticals to bring key therapies to market in China. Amneal’s international expansion strategy focuses on providing access to essential medicines globally. In India, the Company is expanding its local product portfolio and utilizing its local infrastructure to commercialize directly. In Europe, China, and other countries, Amneal is collaborating with distribution partners to bring Amneal’s U.S. FDA approved product portfolio around the world. The Company has finalized distributor partnerships in over 30 countries and began the product registration process across Middle East, Africa, Latin America, and Southeast Asia regions. The Company expects international expansion will be a key vector for growth and add $50 to $100 million in revenues by 2027, and scale further over time. “Sevelamer becomes our first product approval in China and our initial entry into the second largest pharmaceutical market in the world. With our partner, Fosun, we look forward to beginning commercialization this year. At Amneal, we are focused on advancing our internal expansion strategy to bring our portfolio of essential medicines to patients in China and around the world,” said Shyamakant Giri, President, Amneal India Business & Emerging Markets. About Amneal Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. View source version on businesswire.com: Contacts Investor Contact Anthony DiMeo Head of Investor Relations anthony.dimeo@amneal.com Source: Amneal Pharmaceuticals, Inc. View this news release online at:

Drug Approval

05 Jun 2023

·www.globenewswire.com

Carina Biotech Appoints Two New U.S. Based Biotechnology Executives to the Board of Directors

ADELAIDE, Australia, June 05, 2023 (GLOBE NEWSWIRE) -- Carina Biotech (Carina), a cell therapy immuno-oncology company, today announced the appointment of Michael S. Wyzga, M.B.A., and Remus Vezan M.D., Ph.D., to its Board of Directors. Mr. Wyzga is an accomplished biotechnology executive who brings to Carina’s Board over two decades of expertise as a leader and advisor to life sciences companies. Dr. Vezan is an oncology leader who has had immeasurable success in the advancement of numerous cell therapies from early-stage development through commercialization, including a CAR-T cell therapy for hematologic malignancies, which was also one of the first U.S. Food and Drug Administration (FDA) approved CAR-T cell therapies. “We are delighted to welcome two seasoned executives that bring a wealth of expertise in the U.S. biotechnology industry as independent Directors to the Carina Board,” remarked Leanna Read, Ph.D., Chair of Carina’s Board of Directors. “Mike’s track record in the life sciences industry and Remus’ cell therapy clinical developmental expertise will be invaluable as we commence a Phase 1/2a clinical trial for our lead CNA3103 in metastatic colorectal cancer (mCRC) after receiving U.S. IND clearance earlier this year. It is a pivotal time for Carina as CNA3103 advances into clinical development and we look forward to sharing the data supporting the safety and efficacy profile of our LGR5-targeted CAR-T cell therapy candidate with the international oncology community.” Mr. Wyzga is the Founder of MSW Consulting, Inc., a strategic consulting group focused on pharmaceutical and biotech industries. Previously, he served as President, CEO, and a member of the Board of Directors of Radius Health, Inc., a specialty biopharmaceutical company dedicated to bone health and expanding access for patients. Prior to that, Mr. Wyzga held numerous senior management positions at Genzyme Corporation, including as Executive Vice President and Chief Financial Officer, and played roles in the successful development and commercialization of several vital therapies, including Cerezyme for Gaucher disease, Fabrazyme for Fabry disease, Renagel for use in the treatment of hyperphosphatemia, and Campath for chronic lymphocytic leukemia. Currently, Mr. Wyzga serves on four public company Boards, including as Chairman of the Board of X4 Pharmaceuticals, GenSight Biologics, and Mereo BioPharma Group plc, as well as Chair of the Audit Committee at Invivyd, Inc. He received an MBA from Providence College and a B.S. from Suffolk University. Dr. Vezan currently serves as the Chief Medical Officer of CytoImmune Therapeutics, a clinical-stage immuno-oncology company. Prior to that, he held the positions of Chief Medical Officer of CERo Therapeutics and Executive Director of Clinical Development at Kite Pharma. At Kite Pharma, Dr. Vezan was primarily responsible for managing and overseeing the clinical development of CAR-T cell products, including axi-cell/YESCARTA®, the first CAR-T cell therapy approved for relapsed/refractory B-cell lymphoma and brexu-cell/TECARTUS®, the first CAR-T cell therapy approved for mantle cell lymphoma and adult acute lymphoblastic leukemia. Earlier, he served as Medical Director at Pharmacyclics, an AbbVie Company, where he played instrumental roles in the clinical development activities that led to the approval of Ibrutinib (IMBRUVICA®) in lymphoplasmacytic lymphomas (Waldenstrom Macroglobulinemia) and Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). He completed his medical training (M.D. and Ph.D.) at the University of Medicine and Pharmacy Cluj, Romania and University of Bern, Switzerland. Dr. Read concluded, “We would like to take this opportunity to individually thank retiring Directors Nicholas Begakis, Alexander Gosling and Charlie Latham for their guidance through the start-up phases of Carina Biotech. Their insight and contribution have been invaluable.” Mr. Gosling will continue to support Carina on the Governance, People and Remuneration Committee, whilst Mr. Latham will remain Company Secretary. About CNA3103Carina’s proprietary CNA3103 CAR-T cell targets LGR5, a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5 expression has been correlated with poor prognosis. Cancer stem cells are a small sub-population of cells within a tumor with the ability to self-renew, differentiate into the many cell types of a tumor, initiate new tumors, and resist chemotherapy and radiotherapy (leading to relapses). By targeting cancer stem cells, it is hoped that this therapy will reduce the tumor’s ability to generate new cancer cells, resulting in durable tumor suppression and preventing the relapses that are very common in patients with colorectal cancer. Carina’s pre-clinical studies of CNA3103 have shown promising results with complete tumor regression and no tumor recurrence following a single administration. CNA3103 has also demonstrated impressive tumor access and prolonged survival, enabling rejection of new tumors in pre-clinical studies. About Carina BiotechImmuno-oncology company Carina Biotech is developing CAR-T and other adoptive cell therapies for the treatment of solid cancers. In addition to its LGR5-targeted CAR-T cell therapy CNA3103 for advanced colorectal cancer, Carina has a deep pipeline of CAR-T programs. Using its proprietary chemokine receptor platform, Carina aims to improve access to and infiltration of solid cancers by CAR-containing cells, resulting in more potent and specific cancer killing and reduced off-target effects.Carina also has a fully integrated, proprietary manufacturing process that has both reduced manufacturing time and improved CAR-T cell quality, capable of delivering robust “serial-killing” CAR-T cells to patients. For more information please contact: Deborah Rathjen, PhD Rudi MichelsonCEO & Managing Director Monsoon Communications Carina Biotech +61 (0)3 9620 3333+61 418 160 425rudim@monsoon.com.au deborah@carinabiotech.com Stephanie Carrington ICR Westwicke +1 646 277 1282 stephanie.carrington@westwicke.com

Executive ChangeCell TherapyImmunotherapyDrug Approval

100 Deals associated with Sevelamer Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01983	Sevelamer Hydrochloride	V03AE02	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Kidney Disease-Mineral and Bone Disorder	EU	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	IS	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	LI	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	NO	Genzyme Europe BV	25 Feb 2015
Chronic Kidney Diseases	US	Genzyme Corp.	19 Oct 2007
Hyperphosphatemia	EU	Sanofi	28 Jan 2000
Hyperphosphatemia	IS	Sanofi	28 Jan 2000
Hyperphosphatemia	LI	Sanofi	28 Jan 2000
Hyperphosphatemia	NO	Sanofi	28 Jan 2000
Kidney Failure, Chronic	US	Genzyme Corp.	30 Oct 1998

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03001011 (CTgov)	Phase 3	Hyperphosphatemia \| Chronic Kidney Diseases	202	placebo (Placebo)	nmzerowhwj(oitqjbxedw): Median difference (Renvela - Placebo) = -0.210, P-Value = <0.0001	-	28 Jul 2020
				Sevelamer Carbonate (GZ419831) (Renvela)
Phase III Study (ASN2015)	Phase 3	Hyperphosphatemia	213	PA21 (Sucroferric Oxyhydroxide)	yzddicjliu(wvlmasfcxw) = dwgrytntwz yrcluwujtk (ivcqofedxz ) View more	Positive	03 Nov 2015
				Sevelamer Hydrochloride	yzddicjliu(wvlmasfcxw) = hzbypsrcmo yrcluwujtk (ivcqofedxz ) View more
SP395 (ERA2015)	Not Applicable	Uremia Maintenance SOD \| MDA \| AGEs	111	Sevelamer based PB	bjjmkzyknr(zhzwyjdely) = fpnvfbkelt rgahhjnnab (zrubsbcidr ) View more	Positive	21 May 2015
				Calcium based PB	bjjmkzyknr(zhzwyjdely) = ckrugwczxg rgahhjnnab (zrubsbcidr ) View more
J-DOPPS (ERA2014)	Not Applicable	Add-on	-	Sevelamer	ymoaboskja(cclrtumgdl) = zijoqgcrle blqmiuirsb (kemkexejrh )	Positive	01 May 2014
				No Sevelamer	ymoaboskja(cclrtumgdl) = qhhtbywlnt blqmiuirsb (kemkexejrh )
ASN2011	Not Applicable	Hyperphosphatemia Maintenance	138	Sevelamer Hydrochloride	empukmvkbl(oevnqrovrj) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients ctocjyvwih (epdywydbwk )	Positive	08 Nov 2011
SBR759 (ASN2010)	Phase 3	-	203	SBR759	lrsrrvtcnq(kzfxttwmxf) = more frequent with SBR759 ghamylfttp (xqfmianihu ) View more	Positive	16 Nov 2010
				Sevelamer-HCl
SBR759 (ASN2010)	Phase 2	-	203	SBR759 3.0g	wwbynjcvpd(dwdyibuyqf) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) plumyxjgla (bwophfiijn )	Positive	16 Nov 2010
				Sevelamer Hydrochloride 2.4g

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Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis