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

Guangdong Hospital of Traditional Chinese Medicine

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-

NCT01737879

/ TerminatedPhase 4

Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis

The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Start Date01 Oct 2012

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Peginesatide Acetate

100 Translational Medicine associated with Peginesatide Acetate

100 Patents (Medical) associated with Peginesatide Acetate

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 ; Aamir, Aanya ; Kaur, Jyotsna ; 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.

01 Oct 2021·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical SciencesQ2 · MEDICINE

Pharmacokinetics of 40 kDa Polyethylene glycol (PEG) in mice, rats, cynomolgus monkeys and predicted pharmacokinetics in humans

Q2 · MEDICINE

Article

Author: Chimalakonda, Anjaneya ; Zhang, Lisa ; Marathe, Punit ; Caceres-Cortes, Janet ; Khandelwal, Purnima ; Sharda, Nidhi

Conjugation with polyethylene glycol (PEG), PEGylation, has been considered a useful tool to improve drug-like properties of novel small molecules and biologics in drug discovery. PEG40 or 40 kDa PEG is a double-branched PEG, routinely employed to improve the pharmacokinetics (PK) of therapeutics, including successful marketed products such as Pegasys® and Omontys®. However, less is known about the extent of contribution of PEG40 to the overall PK of the PEGylated product. Considering the half-life of PEG40 conjugated PEGylated products ranges from 1 to 14 days in human, this information is immensely valuable. After successfully developing a high sensitivity NMR based analytical method to quantitate PEG40 in mice serum after intravenous (IV) administration (Khandelwal et al., 2019), here, we extend its application to measure PEG40 in serum after IV administration and subcutaneous (SC) absorption in routinely employed non-clinical species in drug discovery, namely, mice, rats and cynomolgus monkeys. We utilized non-compartmental analysis and compartmental modeling to characterize the PK of PEG40 in these non-clinical species. Finally, we employed allometric scaling and Wajima (MRT-Css) method to predict the PK of PEG40 in human after IV administration and SC absorption. In general, our data shows that intrinsic PK parameters of PEG40 in mice, rats and cynomolgus monkeys are in the range of published literature values for PEG40-conjugated products, unless saturable clearance mechanisms are involved. We observed a bioavailability (F) of ~68% in CD-1 mice after SC administration of PEG40. In rats, the clearance (CL) and volume of distribution at steady state (V_ss) after IV infusion of PEG40 were 0.079 mL/min/kg and 0.19 L/kg, respectively; and SC bioavailability was ~20%. In cynomolgus monkeys, after IV infusion, CL and V_ss of PEG40 were 0.037 mL/min/kg and 0.20 L/kg, respectively; and SC bioavailability was ~69%. In addition, our findings indicate flip-flop kinetics of PEG40 in rodents, but not in cynomolgus monkeys. Finally, in human, intrinsic CL and V_ss of PEG40 were projected to be 0.02 mL/min/kg (0.084 L/h) and 0.22 L/kg, respectively. This comprehensive report of PK of PEG40 in non-clinical species and its subsequent prediction in humans is expected to be useful to drug discovery and development scientists for efficient decision-making and optimal resource utilization.

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	United States	Takeda Pharmaceuticals U.S.A., Inc.	27 Mar 2012
Chronic Kidney Diseases	United States	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	United States	Takeda Pharmaceutical Co., Ltd.	01 Sep 2007
Kidney Failure, Chronic	Phase 3	United States	Affymax, Inc.	01 Sep 2007
Red-Cell Aplasia, Pure	Phase 2	France	Takeda Pharmaceutical Co., Ltd.	06 Apr 2006
Red-Cell Aplasia, Pure	Phase 2	Germany	Takeda Pharmaceutical Co., Ltd.	06 Apr 2006
Red-Cell Aplasia, Pure	Phase 2	United Kingdom	Takeda Pharmaceutical Co., Ltd.	06 Apr 2006
Lymphoma	Phase 2	Czechia	Affymax, Inc.	01 Jan 2006
Lymphoma	Phase 2	Poland	Affymax, Inc.	01 Jan 2006
Lymphoma	Phase 2	United Kingdom	Affymax, Inc.	01 Jan 2006
Malignant Solid Neoplasm	Phase 2	Czechia	Affymax, Inc.	01 Jan 2006
Malignant Solid Neoplasm	Phase 2	Poland	Affymax, Inc.	01 Jan 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00314795 (CTgov)	Phase 2	Red-Cell Aplasia, Pure \| Kidney Failure, Chronic	22	Peginesatide	phrfkyoqxj = alrkbtbhko fqvkvzgqud (ilzqefbyex, niipawswet - tkillqrfol) View more	-	14 Mar 2019
NCT01478971 (DIAMOND, CTgov)	Phase 3	Anemia \| Chronic Kidney Diseases	184	Epoetin+Peginesatide	gjqgihvkuz = qjmgdexxnx dfrdhfceiq (wjhltdicpb, vnrkswdkid - lqisotkysl) View more	-	26 May 2014
NCT01737879 (CTgov)	Phase 4	Anemia	41	Peginesatide	jjlewkgkmn(bmjoaidrwo) = miqvgcharx ndbbexnfzw (ymrclygzhv, 0.76) View more	-	21 Apr 2014
NCT00597584 \| NCT00597753 (Pubmed \| N Engl J Med)	Phase 3	Anemia	2,591	Peginesatide	drjfmmnzbg(hclwufqeqs) = lwkijrxfad ilvchjxqbx (wkygttvnnq )	-	24 Jan 2013
				Epoetin	drjfmmnzbg(hclwufqeqs) = iscwfoddmt ilvchjxqbx (wkygttvnnq )
NCT00598442 \| NCT00598273 (Pubmed \| N Engl J Med)	Phase 3	Anemia in chronic kidney disease	983	Peginesatide	zqshxckeao(jsltmskpod): mean difference = 0.03 (97.5% CI, -0.19 to 0.26) View more	-	24 Jan 2013
				Darbepoetin
EMERALD 1, 2 (ASN2012)	Not Applicable	Anemia in chronic kidney disease	1,600	Peginesatide Q4W	mwmhopvvjt(vjnrkvrwxg) = gkecilsdlk hpyddycftl (dkyofcxlnv )	Positive	30 Oct 2012
				Epoetin 1-3X weekly	mwmhopvvjt(vjnrkvrwxg) = mhoakvmnkn hpyddycftl (dkyofcxlnv )
EMERALD 1, 2 (ASN2012)	Phase 3	-	-	Peginesatide	txyyqfwssk(upkynwdrla) = wsgdhgbdpm tyvqenossi (sruzqcwapi )	Positive	30 Oct 2012
EMERALD 1, 2 (ASN2012)	Not Applicable	Anemia in chronic kidney disease high-sensitivity C-reactive protein	1,600	Peginesatide Q4W	hgyyfbrgev(snalfrrijv) = jvxwemqwly qludzejptb (xepginxyys, -0.13 to -0.08)	Positive	30 Oct 2012
EMERALD 1, 2 (ASN2012)	Phase 3	Hodgkin's Lymphoma high-sensitivity C-reactive protein (hsCRP)	-	Peginesatide	dkplfyzjug(uhwwgkxnqt) = fcvswmcmvq foeszizyvr (ctjxzncczx )	Negative	30 Oct 2012
				Epoetin	dkplfyzjug(uhwwgkxnqt) = sqoykgbqdj foeszizyvr (ctjxzncczx )
EMERALD 1, 2 (ASN2012)	Phase 3	Hemodialysis complication	-	Peginesatide	aqshhsqoup(ujghnhsbmh) = loihhjoumx fibgpawqml (rixvtvavsv )	Positive	30 Oct 2012
				Epoetin	aqshhsqoup(ujghnhsbmh) = qcngpqouue fibgpawqml (rixvtvavsv )

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