A non inferiority randomized controlled clinical study on the prevention of delayed platelet reconstruction after allogeneic hematopoietic stem cell transplantation using Hematide and rhTPO.

Start Date01 Aug 2024

Sponsor / Collaborator-

IRCT2015042518842N8

/ CompletedPhase 3

Evaluation of the effect of erythropoetin mouthwash in preventing the incidence and decreasing severity of mucositis in patients undergoing autologous bone marrow transplantation

Start Date20 Feb 2014

Sponsor / Collaborator-

IRCT2013081914407N1

/ CompletedNot ApplicableIIT

The effect of combined therapy with erythropoetin and methylprednisolone in severe relapse of Multiple Sclerosis patients

Start Date22 Jun 2013

Sponsor / Collaborator-

100 Clinical Results associated with Peginesatide Acetate

100 Translational Medicine associated with Peginesatide Acetate

100 Patents (Medical) associated with Peginesatide Acetate

237

Literatures (Medical) associated with Peginesatide Acetate

01 Jan 2024·Bioanalysis

A Singlicate Immunogenicity Method to Detect Anti-Polyethylene Glycol Antibodies: Pre- and Post-Dose of PEGylated Therapies

Review

Author: Sylvester, Alen ; Hughes, Richard ; Kaur, Jyotsna ; Aamir, Aanya ; Jyamubandi, Issa ; Li, Sophia

Aim: Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compounds. Omontys® and Krystexxa® withdrawal and SARS-CoV-2 RNA vaccine anaphylaxis have all been linked to APAs. This project aimed to develop and validate a method to detect total antibodies against PEG, pre- and post-dose. Materials & methods: The repetitive, linear PEG structure prevented the use of a bridging homogenous format, hence the requirement to use a solid-phase extraction and acid dissociation assay coupled with the Meso Scale Discovery® platform. Results & conclusion: Using singlicate analysis, the method was validated to successfully detect APA pre- and post-dose, with a crucial aspect of the method being the preparation of an appropriate negative control.

01 Aug 2022·Journal of pharmaceutical sciencesQ3 · MEDICINE

Commentary: Multiplex dPCR and SV-AUC are Promising Assays to Robustly Monitor the Critical Quality Attribute of AAV Drug Product Integrity

Q3 · MEDICINE

Article

Author: Hayes, David B ; Dobnik, David

Adeno-associated viral (AAV) capsids are an emerging vector technology for a number of novel gene therapy modalities (including transgene delivery and CRISPR gene editing). In this commentary, the proper approach to managing uncertainty (described by Rosenberg et al., 2012) when determining critical quality attributes is stated and applied retrospectively to Peginesatide and prospectively to AAV drug product integrity. With Peginesatide, the omission of advanced analytical techniques (for particles) led to a severe safety risk that appeared post marketing. Peginesatide was withdrawn from the market. One of the critical quality attributes of AAV capsid products is drug product integrity. Drug product integrity is critical because it is related to measuring the active dose of product and because the effects of empty, aggregated, particulate, and partial capsids on efficacy and safety are uncertain. The dose of an AAV capsid vector is typically measured as genomes per milliliter. Regulatory agencies have already recommended digital PCR (dPCR) methods because traditional real-time PCR methods were not precise enough for drug product characterization. However, even with dPCR methods, the practice of characterizing AAV product with a simple empty-full ratio is problematic because simplex dPCR methods count partial genomes as full genomes. The proper management of uncertainty requires a robust quantitative measurement of AAV drug product integrity to ensure control of efficacy and safety. Multiplex dPCR and SV-AUC are promising technologies that together have the potential to enable the development of assays fit for the purpose of measuring AAV drug product integrity more precisely.

26 Oct 2021·World Journal of Stem Cells

Age and genotype dependent erythropoietin protection in COVID-19

Review

Author: Aw, Tar-Choon ; Sutheesophon, Warachaya ; Papadopoulos, Konstantinos I ; Manipalviratn, Somjate

Erythropoietin (EPO) is the main mediator of erythropoiesis and an important tissue protective hormone that appears to mediate an ancestral neuroprotective innate immune response mechanism at an early age. When the young brain is threatened-prematurity, neonatal hyperbilirubinemia, malaria- EPO is hyper-secreted disproportionately to any concurrent anemic stimuli. Under eons of severe malarial selection pressure, neuroprotective EPO augmenting genetic determinants such as the various hemoglobinopathies, and the angiotensin converting enzyme (ACE) I/D polymorphism, have been positively selected. When malarial and other cerebral threats abate and the young child survives to adulthood, EPO subsides. Sustained high ACE and angiotensin II (Ang II) levels through the ACE D allele in adulthood may then become detrimental as witnessed by epidemiological studies. The ubiquitous renin angiotensin system (RAS) influences the α-klotho/fibroblast growth factor 23 (FGF23) circuitry, and both are interconnected with EPO. Here we propose that at a young age, EPO augmenting genetic determinants through ACE D allele elevated Ang II levels in some or HbE/beta thalassemia in others would increase EPO levels and shield against coronavirus disease 2019, akin to protection from malaria and dengue fever. Human evolution may use ACE2 as a "bait" for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) to gain cellular entry in order to trigger an ACE/ACE2 imbalance and stimulate EPO hypersecretion using tissue RAS, uncoupled from hemoglobin levels. In subjects without EPO augmenting genetic determinants at any age, ACE2 binding and internalization upon SARS-CoV-2 entry would trigger an ACE/ACE2 imbalance, and Ang II oversecretion leading to protective EPO stimulation. In children, low nasal ACE2 Levels would beneficially augment this imbalance, especially for those without protective genetic determinants. On the other hand, in predisposed adults with the ACE D allele, ACE/ACE2 imbalance, may lead to uncontrolled RAS overactivity and an Ang II induced proinflammatory state and immune dysregulation, with interleukin 6 (IL-6), plasminogen activator inhibitor, and FGF23 elevations. IL-6 induced EPO suppression, aggravated through co-morbidities such as hypertension, diabetes, obesity, and RAS pharmacological interventions may potentially lead to acute respiratory distress syndrome, cytokine storm and/or autoimmunity. HbE/beta thalassemia carriers would enjoy protection at any age as their EPO stimulation is uncoupled from the RAS system. The timely use of rhEPO, EPO analogs, acetylsalicylic acid, bioactive lipids, or FGF23 antagonists in genetically predisposed individuals may counteract those detrimental effects.

News (Medical) associated with Peginesatide Acetate

05 Feb 2013

·www.biospace.com

Nektar Therapeutics (CA) Announces Initiation of Investigator-Initiated Trial Evaluating Etirinotecan Pegol (NKTR-102) as a Third-Line Treatment in Patients With Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC)

SAN FRANCISCO, Feb. 5, 2013 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced today the start of a Phase 2 investigator-initiated study of etirinotecan pegol in patients with metastatic and recurrent NSCLC. The study is being conducted at the Abramson Cancer Center of the University of Pennsylvania under the direction of Charu Aggarwal, M.D., M.P.H., Assistant Professor of Oncology and Corey Langer, M.D., Professor of Oncology. "Patients with metastatic or recurrent non-small cell lung cancer currently have no standard treatment options after failure of second-line treatment," said Dr. Aggarwal. "In Phase 1 studies, etirinotecan pegol demonstrated encouraging anti-tumor activity in a broad range of solid tumors including non-small cell lung cancer. We are highly interested in evaluating etirinotecan pegol as a potential treatment option for this patient population." The primary endpoint of the Phase 2 study is overall response rate (ORR). Secondary endpoints include progression free survival (PFS), overall survival (OS), median duration of response (DoR) and the safety pro etirinotecan pegol in patients with NSCLC after failure of second-line therapy. The open label, single-arm trial is expected to enroll approximately 37 patients who will receive etirinotecan pegol once every three weeks as monotherapy. "We are very pleased that Dr. Aggarwal and Dr. Langer have identified and proposed this study of single-agent etirinotecan pegol in patients with this difficult to treat cancer," said Robert Medve, M.D., Senior Vice President and Chief Medical Officer of Nektar Therapeutics. "We are pleased that there has been so much interest in etirinotecan pegol from the oncology community. The results of these studies will provide us with a greater understanding of the potential of etirinotecan pegol to benefit patients in need of new treatment options." About NSCLC Lung cancer is the leading cause of cancer-related mortality in the US with NSCLC accounting for approximately 85% of all lung cancer diagnoses [1]. Most NSCLC patients present with loco-regionally advanced or metastatic disease. Platinum-based chemotherapy is the mainstay of treatment for NSCLC in the first-line setting for metastatic disease. Even after response to first-line therapy, patients eventually develop progressive disease and require additional treatment. Currently, pemetrexed, docetaxel, and erlotinib are the only FDA approved agents in the second line setting. Erlotinib is the only agent approved for use in the third-line setting, however, progression-free survival and overall survival remain suboptimal and there are no cytotoxics formally approved to treat patients in the third-line setting. Consequently, there is a need for new therapies that are safe and effective, which may improve overall survival and quality of life. About Etirinotecan Pegol Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate the vasculature of the tumor environment more readily than normal vasculature, increasing the concentration of active drug within tumor tissue to enhance anti-tumor activity. The BEACON study is a Phase 3 clinical study currently evaluating etirinotecan pegol for the treatment of locally recurrent or metastatic breast cancer. In addition to metastatic breast cancer, etirinotecan pegol is also being evaluated for the treatment of ovarian, colorectal and glioma cancers. About Nektar Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for chronic pain conditions, is in Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian and colorectal cancers. Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including Affymax's OMONTYS® for anemia, UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at . Nektar Investor Inquiries: Jennifer Ruddock/Nektar Therapeutics(415) 482-5585 Susan Noonan/SA Noonan Communications, LLC(212) 966-3650 Nektar Media Inquiries: Amanda Connolly/MSL (404) 870-6865 Mike Huckman /MSL (646) 500-7631 1. Siegel, R., D. Naishadham, and A. Jemal, Cancer statistics, 2012. CA Cancer J Clin, 2012. 62(1): p. 10-29. SOURCE Nektar Therapeutics

Collaborate

03 Nov 2011

·www.biospace.com

Nektar Therapeutics (CA) Reports Third Quarter 2011 Financial Results

SAN FRANCISCO, Calif., Nov. 2, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the third quarter ended September 30, 2011. Cash, cash equivalents, and investments at September 30, 2011 were $458.0 million as compared to $315.9 million at December 31, 2010. Revenue for the third quarter of 2011 was $27.1 million, a decrease as compared to $37.9 million in the third quarter of 2010 primarily as a result of the completion as of December 31, 2010 of the amortization of the $125.0 million upfront payment received in 2009 from AstraZeneca for the NKTR-118 and NKTR-119 license agreement. "Nektar is highly focused on continuing to advance our important proprietary drug candidates in pain and cancer," said Howard W. Robin, President and Chief Executive Officer of Nektar. "AstraZeneca's Phase 3 KODIAC program for NKTR-118 for opioid-induced constipation is continuing on-track with AZ targeting regulatory filing in 2013. We are targeting the start of the Phase 3 BEACON study for NKTR-102 in metastatic breast cancer before year-end. NKTR-181, our novel opioid candidate to treat chronic pain, is moving rapidly through Phase 1 clinical development and we plan to announce topline data before year-end. Finally, we plan to IND for NKTR-192, our new clinical candidate to treat acute pain, in the first quarter of 2012." Total operating costs and expenses in the third quarter of 2011 were $48.4 million, an increase compared to $44.2 million in the third quarter of 2010. The increase is primarily a result of higher development expenses related to the advancement of multiple programs in clinical development. Research and development expense increased to $31.0 million in the third quarter of 2011 as compared to $27.7 million for the same quarter in 2010. General and administrative expense was $12.4 million in the third quarter of 2011 as compared to $10.2 million in the third quarter of 2010. Net loss for the third quarter ended September 30, 2011 was $24.1 million or $0.21 loss per share. The company also announced upcoming presentations at medical meetings and scientific congresses scheduled for the fourth quarter of 2011: Chemotherapy Foundation Symposium XXIX: Innovative Cancer Therapy for Tomorrow, New York, NY: Session Title: "Evaluating Single-Agent NKTR-102 in Metastatic Breast Cancer" Presenter: Edith Perez, MD Session Type: Oral Program Track: Breast Cancer Date and Time: November 10, 2011, 1:25 PM Eastern Time Neuroscience 2011: Society for Neuroscience Annual Meeting, Washington, DC: Preclinical data for NKTR-192, a new opioid drug candidate being developed to treat acute pain, will be presented. Abstract Title: "Pharmacological characterization of an orally active opioid analgesic with rapid onset of activity and low abuse liability." Harrison, S., et al. Abstract/Poster Number: #178.10/NN20 Session Title/Track: "Pharmacology Relevant to Pain, Addiction, and Development" Date and Time: Nov 13, 2011, 8:00 AM - 12:00 PM Eastern Time 2011 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, San Francisco, CA Preclinical data for NKTR-102 in ovarian cancer will be presented. Abstract Title: "Strong synergistic activity of NKTR-102 - pegylated liposomal doxorubicin (PLD) combination therapy in a nonclinical model of platinum-resistant A2780 human ovarian cancer." Hoch, et al. Abstract/Poster Number: C209 Session Title/Track: Topoisomerase Inhibitors Date and Time: Nov 15, 2011, 12:30 PM - 2:30 PM Pacific Time Conference Call to Discuss Third Quarter 2011 Financial Results Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT) today, Wednesday, November 2, 2011. The press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investor Relations section of the Nektar website: . The web broadcast of the conference call will be available for replay through December 1, 2011. To access the conference call, follow these instructions: Dial: (866) 203-3436 (U.S.); (617) 213-8849 (international) Passcode: 16610535 (Nektar Therapeutics is the host) An audio replay will also be available shortly following the call through Thursday, December 1, 2011 and can be accessed by dialing (888) 286-8010 (U.S.); or (617) 801-6888 (international) with a passcode of 41636531. In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call. About Nektar Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for NKTR-118, an investigational drug candidate, being evaluated in Phase 3 clinical studies as a once-daily, oral tablet for the treatment of opioid-induced constipation. The agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of NKTR-118 and an opioid. NKTR-181, a novel mu-opioid analgesic molecule wholly-owned by Nektar, is being evaluated in Phase 1 clinical studies. In oncology, NKTR-102, a novel proprietary topoisomerase I-inhibitor, is being evaluated in Phase 2 clinical studies for the treatment of breast, ovarian and colorectal cancers. Nektar's technology has enabled seven approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Additional development stage products that leverage Nektar's proprietary technology platform include peginesatide, for which Affymax and partner Takeda submitted an NDA to the FDA in May 2011, and Baxter's BAX 855, a long-acting PEGylated rFVIII program planned to enter Phase 1 clinical development in 2011. Nektar is headquartered in San Francisco, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at .

CollaborateFinancial StatementAACR

100 Deals associated with Peginesatide Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D09947	Peginesatide Acetate	B03XA04	DB08894

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia	US	Takeda Pharmaceuticals U.S.A., Inc.	27 Mar 2012
Chronic Kidney Diseases	US	Takeda Pharmaceuticals U.S.A., Inc.	27 Mar 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	US	Takeda Pharmaceutical Co., Ltd.	01 Sep 2007
Kidney Failure, Chronic	Phase 3	US	Affymax, Inc.	01 Sep 2007
Red-Cell Aplasia, Pure	Phase 2	FR	Takeda Pharmaceutical Co., Ltd.	06 Apr 2006
Red-Cell Aplasia, Pure	Phase 2	DE	Takeda Pharmaceutical Co., Ltd.	06 Apr 2006
Red-Cell Aplasia, Pure	Phase 2	GB	Takeda Pharmaceutical Co., Ltd.	06 Apr 2006
Neoplasms	Phase 2	CZ	Affymax, Inc.	01 Jan 2006
Neoplasms	Phase 2	PL	Affymax, Inc.	01 Jan 2006
Neoplasms	Phase 2	GB	Affymax, Inc.	01 Jan 2006
Breast Cancer	Phase 1	US	Affymax, Inc.	01 Jan 2008
Breast Cancer	Phase 1	US	Takeda Pharmaceutical Co., Ltd.	01 Jan 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00314795 (CTgov)	Phase 2	Red-Cell Aplasia, Pure \| Kidney Failure, Chronic	22	Peginesatide	khdgkhllze(dmttjrpnwc) = dyuifrkeke xdqilrubjb (onqfsheaam, tsovrqgvim - tgtyflaugj) View more	-	14 Mar 2019
NCT01478971 (DIAMOND, CTgov)	Phase 3	Anemia \| Chronic Kidney Diseases	184	Epoetin+Peginesatide	bkcjqbwoim(ysnpqzamdx) = zakqvnbwhm xvdxvlgags (aeurrethhx, aipuhzvyjl - gkaymbsshi) View more	-	26 May 2014
NCT01737879 (CTgov)	Phase 4	Anemia	41	Peginesatide	wpsankwmbw(njmsmsjark) = qlvvfuddvd mmefqsaoau (khjevruwwv, xvsthwyosn - bxkiqnlech) View more	-	21 Apr 2014
ASN2013	Not Applicable	-	-	Peginesatide	wmucurocdc(ochuccjssn): HR = 1.4 (95% CI, 1.1 - 1.9) View more	Negative	05 Nov 2013
				Epoetin alfa
NCT00597584 \| NCT00597753 (Pubmed \| N Engl J Med)	Phase 3	Anemia	2,591	Peginesatide	mbuxgnjexv(vtmzzzisto) = fqxrgyefls dekpmlvzvc (zrhhxbreyd )	-	24 Jan 2013
				Epoetin	mbuxgnjexv(vtmzzzisto) = uitbcxguhd dekpmlvzvc (zrhhxbreyd )
NCT00598442 \| NCT00598273 (Pubmed \| N Engl J Med)	Phase 3	Anemia in chronic kidney disease	983	Peginesatide	sfkcnhfeuk(tbuvezudqc): mean difference = 0.03 (97.5% CI, -0.19 to 0.26) View more	-	24 Jan 2013
				Darbepoetin
ASN2012	Not Applicable	EPOR \| cKIT \| CD71 ... View more	-	Peginesatide	qnfymetjbc(ivtbmtahpy) = zobthxjhtn azvjajiogc (krmfchbcbr ) View more	-	30 Oct 2012
				rHuEPO	uogjbwuuji(poeibrojua) = yzhpreicww bnnjmugeuj (zuurozgrne )
ASN2012	Phase 3	Chronic Kidney Diseases	-	Peginesatide IV	ggcnpzpxjb(yvkkkyoolr) = leglylzwjt ucuzfkkpmc (zcppjexnso ) View more	Positive	30 Oct 2012
				Peginesatide SC	novlicbtsj(mdvimtdghd) = qimdcurdrp ggdvqogrym (wwgvznxpte ) View more
EMERALD 1 \| EMERALD 2 (ASN2012)	Not Applicable	Anemia in chronic kidney disease	1,600	Peginesatide Q4W	xxlrdbjgrw(phwxiierpq) = eskjcdklbj gsrxqippei (mdmvmttpxk )	Positive	30 Oct 2012
				Epoetin 1-3X weekly	xxlrdbjgrw(phwxiierpq) = ltbsvlpegk gsrxqippei (mdmvmttpxk )
EMERALD 1 \| EMERALD 2 (ASN2012)	Phase 3	-	-	Peginesatide	ifjuvuseqy(xanxmipdbg) = szsmzxewca eigubpmmxy (toytupcsys )	Positive	30 Oct 2012

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