To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

Start Date01 Sep 2011

Sponsor / Collaborator

Brown University

[+7]

NCT01227408 / WithdrawnPhase 2IIT

Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer

The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and capecitabine. It is expected this combination will at least maintain the efficacy of a traditional chemotherapy regimen but will be associated with less toxicity, particularly nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a chemotherapy regimen whose components (or administration schedule) are associated with minimal or no alopecia and are also considered to have low emetogenic potential.
In an attempt to improve the efficacy of the regimen the investigators plan to study an alternate schedule of cyclophosphamide and methotrexate administration (metronomic chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of conventional cytotoxic chemotherapy administered concurrently.
In this trial the investigators aim to determine the clinical and pathologic response rate of 12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic chemotherapy with cyclophosphamide and methotrexate will be administered during the 24 weeks of chemotherapy.

Start Date01 Feb 2009

Sponsor / Collaborator

University of Southern California

[+1]

NCT00763750 / CompletedPhase 2IIT

BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.

The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.

Start Date01 Oct 2008

Sponsor / Collaborator

Brown University

[+2]

100 Clinical Results associated with Paclitaxel Poliglumex

100 Translational Medicine associated with Paclitaxel Poliglumex

100 Patents (Medical) associated with Paclitaxel Poliglumex

293

Literatures (Medical) associated with Paclitaxel Poliglumex

01 Oct 2024·Molecular neurobiology

The Interplay of Mitochondrial Bioenergetics and Dopamine Agonists as an Effective Disease-Modifying Therapy for Parkinson’s Disease

Review

Author: Mazahir, Iqra ; Kaushik, Pooja ; Khan, Sara Akhtar ; Parvez, Suhel ; Neha

Parkinson's disease (PD) is a progressive neurological ailment with a slower rate of advancement that is more common in older adults. The biggest risk factor for PD is getting older, and those over 60 have an exponentially higher incidence of this condition. The failure of the mitochondrial electron chain, changes in the dynamics of the mitochondria, and abnormalities in calcium and ion homeostasis are all symptoms of Parkinson's disease (PD). Increased mitochondrial reactive oxygen species (mROS) and an energy deficit are linked to these alterations. Levodopa (L-DOPA) is a medication that is typically used to treat most PD patients, but because of its negative effects, additional medications have been created utilizing L-DOPA as the parent molecule. Ergot and non-ergot derivatives make up most PD medications. PD is successfully managed with the use of dopamine agonists (DA). To get around the motor issues produced by L-DOPA, these dopamine derivatives can directly excite DA receptors in the postsynaptic membrane. In the past 10 years, two non-ergoline DA with strong binding properties for the dopamine D2 receptor (D2R) and a preference for the dopamine D3 receptor (D3R) subtype, ropinirole, and pramipexole (PPx) have been developed for the treatment of PD. This review covers the most recent research on the efficacy and safety of non-ergot drugs like ropinirole and PPx as supplementary therapy to DOPA for the treatment of PD.

01 Oct 2024·Transplant Infectious Disease

Use of letermovir for cytomegalovirus primary prophylaxis in lung transplant recipients

Article

Author: Wright, Jennifer ; Arunachalam, Ambalavanan ; Paplaczyk, Krista ; Prom, Alyson ; Tomic, Rade ; Borkowski, Nicole ; Subramani, Mrinalini Venkata ; Miner, Brad ; Myers, Catherine N. ; Kleiboeker, Hanna L. ; Betensley, Alan D. ; Wang, Jacob

Abstract:

Background:

Cytomegalovirus (CMV) is a driver of negative outcomes after lung transplant (LTX) and primary prophylaxis (PPX) with valganciclovir (VGC) is standard‐of‐care. VGC is associated with myelosuppression, prompting interest in letermovir (LTV).

Methods:

Adults receiving LTX between April 1, 2015, and July 30, 2022, at our institution were evaluated. Patients were excluded if low CMV risk (D‐/R‐), survived <90 days post‐LTX, or transferred care before PPX withdrawal. Primary outcomes were leukopenia (white blood cell count [WBC] ≤ 3.0 × 109/L), severe leukopenia (WBC ≤ 2.0 × 109/L), and neutropenia (absolute neutrophil count ≤ 1500 cells/µL) requiring granulocyte‐colony stimulating factor (GCSF) on PPX. Secondary outcomes included breakthrough CMV infection and post‐PPX CMV infection.

Results:

204 patients met inclusion criteria: 175 patients on VGC and 29 patients on LTV (after VGC conversion). Most patients received bilateral LTX (62.7%) with non‐lymphocyte‐depleting induction (96.6%) and moderate‐risk serostatus (D+/R+, 48.5%). Patients transitioned from VGC to LTV after a mean of 178 days (SD 80.8 days) post‐transplant. Patients on VGC experienced significantly more leukopenia (82.3% vs. 58.6%, p = 0.008), severe leukopenia (57.1% vs. 31.0%, p = 0.016), and neutropenia requiring GCSF (70.9% vs. 51.7%, p = 0.048). Breakthrough (5.7% vs. 3.4%, p = 0.955) and post‐PPX (24.6% vs. 37.9%, p = 0.199) infections were similar. A subgroup analysis of patients with high‐risk serostatus showed similar trends, though did not reach statistical significance.

Conclusions:

In this single‐center study, the incidence of leukopenia and neutropenia requiring GCSF were reduced with LTV compared to VGC. Breakthrough and post‐PPX infections were not significantly different. This evidence suggests that LTV has comparable efficacy with reduced myelosuppression compared to VGC in LTX recipients, and may be an appropriate alternative for PPX. image

01 Jul 2024·Current drug delivery

Preparation, Characterization and Drug Delivery Research of γ-Polyglutamic Acid Nanoparticles: A Review

Review

Author: He, Yan ; Ma, Xia ; Liu, Zhihan

Abstract::

γ-Polyglutamic acid is a kind of biomaterial and environmentally friendly polymer material with the characteristics of water solubility and good biocompatibility. It has a wide range of applications in medicine, food, cosmetics and other fields. This article reviews the preparation, characterization and medical applications of γ-polyglutamic acid nanoparticles. Nanoparticles prepared by using γ- polyglutamic acid not only had the traditional advantages of enhancing drug stability and slow-release effect, but also were simple to prepare without any biological toxicity. The current methods of nanoparticle preparation mainly include the ion gel method and solvent exchange method, which use the total electrostatic force, van der Waals force, hydrophobic interaction force and hydrogen bond force between molecules to embed materials with different characteristics. At present, there are more and more studies on the use of γ-polyglutamic acid to encapsulate drugs, and the research on the mechanism of its encapsulation and sustained release has gradually matured. The development and application of polyglutamic acid nanoparticles have broad prospects.

News (Medical) associated with Paclitaxel Poliglumex

27 Jul 2023

·www.sciencedaily.com

Self-healing plastic becomes biodegradable

Chemists develop mineral plastics with numerous positive properties from sustainable basic building blocks and, together with biologists, demonstrate the material's excellent microbiological degradability. Imagine a plastic like this: harder than common plastics, non-flammable, and even with self-healing properties. But that is not all! It can be produced at room temperature in water, which is very energy-efficient and does not require toxic solvents. Before hardening, you can shape the plastic in any way you want -- like chewing gum. By adding water, it can also be converted back to its "chewing gum" form at any time, reshaped and thus recycled as often as desired. Is that impossible? No, it is not! In 2016, the research team around Konstanz chemist Helmut Cölfen presented just such a material -- a mineral plastic. However, even though the plastic, with its novel manufacturing process and outstanding material properties, has since attracted great interest from industry, it still had a crucial shortcoming from the Konstanz chemists' point of view: due to its chemical composition, it was difficult to biodegrade. A new ingredient for greater environmental compatibility "Previously, we used polyacrylic acid to produce our mineral plastic. Chemically, this acid has the same backbone as polyethylene, which is known to cause major problems in the environment because it is hardly biodegradable," explains Cölfen. The research team led by Cölfen and Ilesha Avasthi, a postdoc in Cölfen's lab, therefore set to work looking for an alternative basic building block to develop an environmentally compatible mineral plastic that retains the intriguing properties of the original material. And they found what they were looking for. In their current publication in the journal Small Methods, the Konstanz chemists present the next generation of their mineral plastic. Instead of petroleum-based ingredients such as polyacrylic acid, they now use polyglutamic acid. This natural biopolymer is readily available in large quantities and can even be obtained sustainably, for example from biotechnological production using microorganisms. A variety of microorganisms that already exist in the environment can degrade polyglutamic acid. "Our new mineral plastic has the same positive properties as the previous one, but has the decisive advantage that its basic building block -- polyglutamic acid -- can be produced with the help of microorganisms and is completely biodegradable," says Helmut Cölfen. Support from biologists In order to prove that this biodegradability also applies to the new mineral plastic itself and not just to its individual components, the chemists enlisted the support of David Schleheck and postdoc Harry Lerner from the Department of Biology at the University of Konstanz. "Helmut Cölfen has created a new type of mineral plastic in his laboratory, and our task now was to make it disappear again with the help of microorganisms," says Schleheck with a smile. In degradation experiments, the biologists were able to show that microorganisms found in forest soils, for example, began metabolizing the mineral plastic after just a few days. After only 32 days, the microorganisms had completely degraded the plastic. So the researchers have actually succeeded in making the mineral plastic with all its positive material properties now also sustainable and biodegradable.

26 Jul 2022

·www.biospace.com

Organicell Announces Matt Sinnreich as CEO

MIAMI, FL / ACCESSWIRE / July 26, 2022 / Organicell Regenerative Medicine, Inc. (OTCQB:OCEL), a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics in the extracellular vesicle space, announced today that the board of directors has appointed Matt Sinnreich as Chief Operating Officer and acting CEO. Sinnreich will replace Mr. Albert Mitrani, the founder of Organicell and CEO since September 2019, who is stepping down to serve as the Company's EVP of sales. Sinnreich, an early-stage investor in Organicell, helped fund the company's audit in 2020 to bring their financials current and was instrumental in the creation of their flagship brand: Zofin. Sinnreich comes from a development and entrepreneurial background. His track record includes profitable corporate exits, successful real estate transactions, and owner-operated residential and commercial real estate developments. Sinnreich has closed tens of millions in various financing instruments including everything from traditional real estate debt, fundraising for private companies, to collateralized derivatives and swaps. Sinnreich is an early-stage investor in the ready to drink tequila-seltzer, Mamitas and owns a minority interest in Craig's Vegan Ice Cream. Sinnreich graduated from the University of Miami Business School in 2008 where he also won the 2008 Rothschild Business Plan Competition. In response to his appointment, Sinnreich stated: "I am humbled and grateful that the board and new investment groups have entrusted me to take Organicell to the next level. I believe that exosomes are a key element in the future of medicine and this company has the team to make that a reality. Albert and Mari Mitrani are pioneers in this space. They have assembled an incredible science team, developed an amazing product line, and built top tier production labs. All the ingredients are here for this company to become a major success. As COO and acting CEO I will be focused on creating additional financing vehicles, growing the awareness of our products and brand, and most importantly maintaining an honest, transparent relationship with the shareholders. My priorities right now are to work with our CFO, Ian Bothwell, to build out Organicell's core executive team. I will pull from my network to surround myself with the best and brightest in the medical and financial arenas. I plan to create a robust ERP and data management system and to set up additional financing vehicles to fund our clinical trials. I will also be taking to market Organicell's newest biological product: Patient Pure X™ (PPX™). PPX™ is Organicell's first autologous product that is a non-manipulated biologic that concentrates a patient's exosomes from their own peripheral blood. In plain English: we can concentrate a patient's exosomes from their own blood. Organicell's science team and researchers are currently conducting studies to prove PPX's effectiveness on pain, hair loss, its potential for aesthetic uses, and surgical recovery. Organicell's products have shown promising results in the early-stage data that has been collected. Once the company has the adequate data from our clinical trials to make the claims we are studying - I believe this company will be a disrupter in the biotech industry." About Organicell Regenerative Medicines, Inc. Organicell Regenerative Medicine, Inc. (OTCQB:OCEL) is a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and the provision of other related services. The Company's proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. To learn more, please visit Forward-Looking Statements Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the "Securities Act"), the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as "will", "believes", "expects", "potential", or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally, and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website ( ). You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release. Media Contact: Joshua Rodriguez CEO and Founder CNA Finance, LLC. (503) 464-6502 SOURCE: Organicell Regenerative Medicine, Inc. View source version on accesswire.com:

100 Deals associated with Paclitaxel Poliglumex

External Link

KEGG	Wiki	ATC	Drug Bank
D05333	Paclitaxel Poliglumex	L01CD03	DB13809

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	AR	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	BG	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	HU	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	MX	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	PL	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	RO	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	RU	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	UA	CTI BioPharma Corp.	01 Dec 2005
Non-Small Cell Lung Cancer	Phase 3	GB	CTI BioPharma Corp.	01 Dec 2005
progressive non-small cell lung cancer	Phase 3	US	CTI BioPharma Corp.	01 Jan 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00108745 (CTgov)	Phase 3	Mucinous Adenocarcinoma \| Fallopian Tube Clear Cell Adenocarcinoma \| Ovarian mixed epithelial carcinoma ... View more	1,157	Quality-of-Life Assessment+Paclitaxel Poliglumex (Arm I (Paclitaxel Poliglumex))	zivwphxada(vbiwekqyvj) = vehqnegkrb tkpsaqhirx (yejodjxipp, rpypvzmdwt - cgdrfsdhna) View more	-	01 Apr 2021
				Quality-of-Life Assessment+paclitaxel (Arm II (Paclitaxel))	zivwphxada(vbiwekqyvj) = ybjumszlnk tkpsaqhirx (yejodjxipp, oppgsuzarr - ekvmasklft) View more
NCT01402063 (CTgov)	Phase 2	Glioblastoma Multiforme	63	PPX (CT2103) (Radiation Plus PPX(CT2103)	mdzapxclrs(aoqpifwvot) = sxdllcchnt ddswxmmhez (ipmahewjed, vmpbyxceox - ycjgjmzrhf)	-	11 Jun 2015
				Temozolomide (Radiation + Temozolomide)	mdzapxclrs(aoqpifwvot) = ntmecpavll ddswxmmhez (ipmahewjed, xrzutsfnnz - teshfhuwwp)
NCT00352690 (CTgov)	Phase 2	Non-small cell lung cancer stage III	10	External beam radiation therapy+Carboplatin+Paclitaxel poliglumex (Cohort 1 (First 12 Eligible Patients))	yintmzigux(cvybifkxhv) = wginelhflv frjvkpvbmu (lofhwprpde, enghobzzts - jwjisscqbj) View more	-	27 May 2015
				External beam radiation therapy+Carboplatin+Paclitaxel poliglumex (Cohort 2 (Remaining Patients))	nzixshrgut(pkmgzalesn) = vtykbsnelt rqdxzcqlhs (ujymbsuwbo, baflpdioye - varukwwlan) View more
NCT01402063 (Pubmed \| Am J Clin Oncol)	Phase 2	High grade glioma	25	Paclitaxel poliglumex	rdrvyrwypt(oshrmkxlqc) = Hematologic toxicity lasted up to 5 months suggesting a drug interaction between PPX and temozolomide xswmwasztd (mhjpbsdmcx ) View more	-	01 Oct 2014
NCT00763750 (BrUOG-Brain-223, CTgov)	Phase 2	Brain Cancer	25	TMZ+PPX	hybjeqlcuy(uwhytvewfh) = paregttjkm tkualoeucp (czcvluizet, feccgtrcat - hvxjyqizqe) View more	-	16 Dec 2013
ASCO2012	Phase 1/2	Head and Neck Neoplasms	14	Radiation therapy	ckayztmuga(jqsqyfomhh) = bobeqfsvzc zjvzxwwumb (lwgbclyhlw )	-	20 May 2012
ASCO2011	Phase 2	Non-Small Cell Lung Cancer	29	CT-2103	lmjutjpmok(ypghojkixa) = swtxishpgc knkchdtajm (jgpvolonkv ) View more	Negative	20 May 2011
ASCO2011	Phase 2	High grade glioma	25	Paclitaxel poliglumex (PPX)	nrvjmlyggt(wiwhpqgrif) = yvoaenppox ehubkmkwnx (cgcfurrxcq ) View more	-	20 May 2011
				Temozolamide (TMZ)	nrvjmlyggt(wiwhpqgrif) = idmlwrolrg ehubkmkwnx (cgcfurrxcq ) View more
NCT00054197 (Pubmed \| J Thorac Oncol)	Phase 3	Advanced Lung Non-Small Cell Carcinoma	-	Paclitaxel Poliglumex (PPX)	zijxyezjsp(efuxziiryp) = oqgrofgmps mbhebycuid (huxmcmtrjt ) View more	-	01 Jul 2008
				Gemcitabine or Vinorelbine	zijxyezjsp(efuxziiryp) = brpwpdyqos mbhebycuid (huxmcmtrjt ) View more

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