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]

100 Clinical Results associated with Paclitaxel Poliglumex

100 Translational Medicine associated with Paclitaxel Poliglumex

100 Patents (Medical) associated with Paclitaxel Poliglumex

244

Literatures (Medical) associated with Paclitaxel Poliglumex

01 Jan 2026·EXPERIMENTAL NEUROLOGY

Pramipexole improves cognitive deficits and synaptic plasticity impairments in 3xTg-AD mice through enhancing autophagy

Article

Author: Cui, Chenglong ; Han, Feifei ; Tuo, Chunmei ; Sui, Xiaofan ; Wu, Meina ; Jiao, Juanjuan ; Cai, Hongyan

Autophagy dysfunction plays important roles in the pathogenesis of Alzheimer's disease (AD), and activation of autophagy might be a potential strategy in AD treatment. Although some autophagy inducers play beneficial roles in AD, no autophagy inducer has been available in AD clinical treatment due to lack of efficacy or obvious side effects. A recent study demonstrated that pramipexole (PPX) can activate autophagy in the brain without interfering with protein synthesis, thereby avoiding the side effects associated with prolonged use of an autophagy inducer. However, whether PPX can exert neuroprotective effects on AD and whether its potential mechanism is related to autophagy remains unclear. In the present study, the effects of PPX on the cognitive function of 3xTg-AD mice were observed using multiple behavioral tests, then synaptic plasticity was evaluated through in vivo hippocampal electrophysiological recordings and by measuring synaptic proteins, while Aβ and tau pathologies were detected using immunofluorescence staining and western blot. Finally, autophagy was detected and the potential target was predicted using bioinformatics analysis, qRT-PCR and molecular docking. Results demonstrated that PPX significantly improved cognitive deficits and hippocampal long-term potentiation (LTP) depression, increased the expression of PSD95, reduced Aβ deposition and tau hyperphosphorylation, activated autophagy by increasing LC3-II/LC3-I ratios and decreasing p62 levels, and restored Beclin1 expression. Bioinformatics analysis identified MAPK1 as a key target in PPX-ameliorated AD by enhancing autophagy. These findings suggest that PPX alleviates AD-related cognitive deficits and neuropathologies through increased autophagy, emphasising its potential as a disease-modifying therapeutic strategy for AD.

01 Jan 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Development of sublingual films and electrospun nanofibers of pramipexole for the immediate relief of dyskinesias in Parkinson’s disease

Article

Author: Caon, Thiago ; Pigatto Stringhi, Júlia Elizabeth ; Saatkamp, Rodrigo Henrique ; Gomes, Marina ; Rauber, Gabriela Schneider ; Parize, Alexandre Luis ; Bernardo Port, Bianca Costa

Oral levodopa/carbidopa tablets remain the gold standard therapy for Parkinson's disease; however, long-term administration of these drugs has been associated with dyskinesias and "on-off" motor fluctuations. Non-ergot dopaminergic agonists such as pramipexole (PPX) have been proposed to mitigate these complications. Another common problem found in these patients is dysphagia, encouraging studies with alternative administration routes. In this context, this study aimed to develop polymeric films and nanofibers for the sublingual delivery of PPX. Polyvinyl alcohol (PVA) matrices, with or without chitosan (CH), were prepared by electrospinning and solvent casting techniques. Electrospun fibers exhibited greater elongation at break, enhanced hydration and faster disintegration than cast films. Incorporation of CH led to smaller fiber diameters (300 ± 70 nm) than CH-free nanofibers (513 ± 105 nm). Cast films (57.3 % to 74.82 %) provided faster PPX release than electrospun fibers (35.57 % to 48.87 %) within 75 s. The presence of CH in nanofibers reduced the mucoadhesion due to stronger chemical interactions between the polymers, also explaining the lower sublingual permeability of CH nanofibers compared to CH cast films (5.98 vs. 18.95 µg/cm², respectively). In future studies, cast films should be prioritized due to increased mucoadhesion, release rate and sublingual permeability. Taken together, these effects would contribute to an immediate relief of motor symptoms in patients with Parkinson's disease. Further pharmacokinetics studies in humans are needed to confirm the benefits suggested here.

01 Jan 2026·ANESTHESIOLOGY

Revisiting Infusion Rate Limitations for Continuous Lumbar Plexus Blocks in Children and Adolescents with 0.2% Ropivacaine: A Pharmacokinetic Analysis

Article

Author: Polaner, David M. ; White, Klane K. ; Sunder, Rani A. ; Adams, Trevor L. ; Gentry, Katherine R. ; Anderson, Corrie T. M. ; Henthorn, Thomas K.

Background::

A limitation to widespread use of pediatric lumbar plexus blocks is a scarcity of pharmacokinetic data. Concerns about absorption and consequent toxicity promote low doses, resulting in frequent episodes of breakthrough pain. The authors determined population pharmacokinetics of unbound ropivacaine and its toxic metabolite 2′,6′-pipecoloxylidide (PPX) after a bolus dose and during continuous infusion to simulate current dosing guidelines relative to the toxic threshold of the combined effects of ropivacaine and PPX in the pediatric population.

Methods::

A total of 20 healthy children, age 4 to 18 yr, undergoing unilateral hip/femur surgery who received lumbar plexus blocks with 0.2% ropivacaine bolus (2 mg/kg) and an infusion (0.4 mg · kg –1 · h –1 ) were prospectively enrolled. Blood samples were collected at regular intervals over 26 h to measure total and unbound plasma ropivacaine and PPX concentrations.

Results::

The concentration versus time plots show an approximately 5-fold range of plateau unbound plasma ropivacaine concentrations and 10-fold range of PPX among the patients, suggesting similar variability in unbound ropivacaine and PPX clearances, respectively. Ropivacaine and PPX exposure simulations using standard infusion rates (0.4 mg · kg –1 · h –1 ) with regular bolus dose administration of 0.2 mg/kg resulted in the 95th percentile of sum of unbound ropivacaine plus 1/12 PPX concentrations approaching the estimated toxic threshold due to late-occurring approach to high steady state plasma concentrations of PPX. Discontinuing the continuous infusion and replacing it with larger bolus doses every 6 h resulted in lower simulated plasma ropivacaine and PPX plasma concentrations.

Conclusions::

Pharmacokinetic modeling supports a bolus dose of 2 mg/kg, continuous infusion rates of ropivacaine at 0.4 mg · kg –1 · h –1 , and boluses every 6 h of 0.2 mg/kg in healthy children for lumbar plexus blockade for the first 24 h. After that, with currently accepted toxic thresholds for ropivacaine and PPX, consideration should be given to dosing strategies that reduce or eliminate infusions and support timed boluses.

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.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-small cell lung cancer stage IIIB	Phase 3	Hungary	-	23 Jan 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	CTI BioPharma Corp.	01 Jan 2003
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	CTI BioPharma Corp.	01 Jan 2003
progressive non-small cell lung cancer	Phase 3	United States	CTI BioPharma Corp.	01 Jan 2003
Recurrent Non-Small Cell Lung Cancer	Phase 3	United States	CTI BioPharma Corp.	01 Jan 2003
Recurrent Non-Small Cell Lung Cancer	Phase 3	Canada	CTI BioPharma Corp.	01 Jan 2003
HER2-negative breast cancer	Phase 2	United States	CTI BioPharma Corp.	01 Feb 2009
Astrocytoma	Phase 2	United States	Brown University	01 Oct 2008
Glioblastoma	Phase 2	United States	Brown University	01 Oct 2008
Glioblastoma Multiforme	Phase 2	United States	Brown University	01 Oct 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00108745 (CTgov)	Phase 3	Mucinous Adenocarcinoma \| Ovarian mixed epithelial carcinoma \| Fallopian Tube Clear Cell Adenocarcinoma ... View more	1,157	Quality-of-Life Assessment+Paclitaxel Poliglumex (Arm I (Paclitaxel Poliglumex))	llgtxlmygo(pwdxnyvfjx) = grwzqnbiuf wzoisypuot (vwqwdqrrpk, yhhmglynbl - gbketgdqzi) View more	-	01 Apr 2021
				Quality-of-Life Assessment+Paclitaxel (Arm II (Paclitaxel))	llgtxlmygo(pwdxnyvfjx) = amfxdftzws wzoisypuot (vwqwdqrrpk, hjtifyqcmu - vhuqufwucb) View more
NCT01402063 (CTgov)	Phase 2	Glioblastoma Multiforme	63	PPX (CT2103) (Radiation Plus PPX(CT2103)	xgjomulqux = pzbwpeqtac lkapadyukn (vozyghnlym, hwvexqeycs - euoxidipdo)	-	11 Jun 2015
				Temozolomide (Radiation + Temozolomide)	xgjomulqux = fmtbaweczj lkapadyukn (vozyghnlym, ixtydrneua - tumvffhdvk)
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))	ltwhxnkdys = ychtiriulo ayiqpvvaec (lihyvnzrwt, uaukpobhyu - nimerxpqtq) View more	-	27 May 2015
				External beam radiation therapy+Carboplatin+Paclitaxel poliglumex (Cohort 2 (Remaining Patients))	anokiwmorq(lasyxxdhsr) = typplcsvez wciogyujoc (ltlrwkryer, enhcmnyodr - jztolsahqj) View more
NCT01402063 (Brown University Oncology Group Study, Pubmed \| Am J Clin Oncol)	Phase 2	High grade glioma	25	Paclitaxel poliglumex	sqlpixsaon(unrysgugqv) = Hematologic toxicity lasted up to 5 months suggesting a drug interaction between PPX and temozolomide rlhyybqihc (ownyxwtpip ) View more	-	01 Oct 2014
NCT00487669 (CTgov)	Phase 2	Advanced Lung Non-Small Cell Carcinoma	14	pemetrexed+paclitaxel poliglumex (Level 1)	hmlwfoadux = udekkgjose uvosreubdy (azcwrtqxgk, zjhqhflpwy - fjbxvyzzie) View more	-	09 Jan 2014
				pemetrexed+paclitaxel poliglumex (Level 2)	hmlwfoadux = hdmscnhllw uvosreubdy (azcwrtqxgk, rcffshgatv - wlppcpndna) View more
NCT00763750 (BrUOG-Brain-223, CTgov)	Phase 2	Astrocytoma \| Glioblastoma Multiforme \| Glioblastoma ... View more	25	TMZ+PPX	wnwpekhvlg = nqakjfgrqw xvbmjlwtyd (qbovofjjfb, kdtqmtccdp - iswkrwxcwg) View more	-	16 Dec 2013
ASCO2012	Phase 1/2	Head and Neck Neoplasms	14	Radiation therapy	yeslusskhf(jkawysxmbg) = xuxfrjzgjc oscsvogmzp (hzknjrkbeg )	-	20 May 2012
ASCO2011	Phase 2	Non-Small Cell Lung Cancer	29	CT-2103	mdzqppxipg(ynskapuvqk) = fkflrlopjq zkjpzlzyyp (srrswzrnvc ) View more	Negative	20 May 2011
ASCO2011	Phase 2	High grade glioma	25	Paclitaxel poliglumex (PPX)	odqwdbgerx(jjsyujjmjw) = arcjsuphgf edkxxvivwh (tdjpwnyokh ) View more	-	20 May 2011
				Temozolamide (TMZ)	odqwdbgerx(jjsyujjmjw) = znxxrmviwl edkxxvivwh (tdjpwnyokh ) View more
ASTRO2010	Phase 2	High grade glioma	17	Paclitaxel Poliglumex (PPX)	vqmfkqkzby(smwksewrxx) = Three patients developed grade IV thrombocytopenia during treatment and had to be taken off study fefghuvrnq (jfkahuliej ) View more	Positive	01 Nov 2010
				Temozolomide (TMZ)

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