A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI

This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI.

Start Date13 Nov 2020

Sponsor / Collaborator

Rediscovery Life Sciences LLC

ChiCTR2000030029 / SuspendedEarly Phase 1

A multi-center study on the efficacy and safety of suramin sodium in adult patients with novel coronavirus pneumonia (COVID-19)

Start Date20 Feb 2020

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University School of Medicine

ChiCTR2100042004 / SuspendedEarly Phase 1IIT

A multi-center study on the efficacy and safety of suramin sodium in adult patients with novel coronavirus pneumonia (COVID-19)

Start Date19 Feb 2020

Sponsor / Collaborator-

100 Clinical Results associated with Suramin Sodium

100 Translational Medicine associated with Suramin Sodium

100 Patents (Medical) associated with Suramin Sodium

3,994

Literatures (Medical) associated with Suramin Sodium

01 Jun 2024·Neural regeneration research

The bumpy road of purinergic inhibitors to clinical application in immune-mediated diseases.

Article

Author: Wyss, Matthias T ; Herwerth, Marina ; Heuer, Christine

ABSTRACT:

Purinergic signaling plays important roles throughout the body in the regulation of organ functions during and following the disruption of homeostasis. This is also reflected by the widespread expression of two families of purinergic receptors (P1 and P2) with numerous subtypes. In the last few decades, there has been increasing evidence that purinergic signaling plays an important role in the regulation of immune functions. Mainly, signals mediated by P2 receptors have been shown to contribute to immune system-mediated pathologies. Thus, interference with P2 receptors may be a promising strategy for the modulation of immune responses. Although only a few clinical studies have been conducted in isolated entities with limited success, preclinical work suggests that the use of P2 receptor inhibitors may bear some promise in various autoimmune diseases. Despite the association of P2 receptors with several disorders from this field, the use of P2 receptor antagonists in clinical therapy is still very scarce. In this narrative review, we briefly review the involvement of the purinergic system in immunological responses and clinical studies on the effect of purinergic inhibition on autoimmune processes. We then open the aperture a bit and show some preclinical studies demonstrating a potential effect of purinergic blockade on autoimmune events. Using suramin, a non-specific purinergic inhibitor, as an example, we further show that off-target effects could be responsible for observed effects in immunological settings, which may have interesting implications. Overall, we believe that it is worthwhile to further investigate this hitherto underexplored area.

01 Jan 2024·American journal of physiology. Cell physiology

Mechanosensitivity and mechanotransductive properties of osteoclasts

Article

Author: Dsouza, Chrisanne ; Komarova, Svetlana V

Osteoclasts are rarely considered as cells that participate in mechanical signaling in bone. We show that osteoclasts are capable of sensing and transmitting mechanical signals to neighboring cells. Mechanical stimulation commonly induces minor repairable membrane injury in osteoclasts. ATP and especially ADP were found to play important roles in the mechanoresponsiveness of osteoclasts. This study highlights the importance of osteoclast mechanobiology especially in conditions of altered mechanical loading associated with bone loss, such as in microgravity.

01 Jan 2024·Comparative biochemistry and physiology. Part B, Biochemistry & molecular biology

Uncovering the roles of sirtuin activity and food availability during the onset of the heat shock response in the California mussel (Mytilus californianus): Implications for antioxidative stress responses

Article

Author: Tomanek, Lars ; May, Melissa A

Sirtuins are a class of NAD⁺-dependent deacylases, with known regulatory roles in energy metabolism and cellular stress responses in vertebrates. Previous work using marine mussels have suggested a similar role in invertebrates, providing a potential mechanism linking food availability and thermal sensitivity in Mytilids. Sirtuin inhibitors affect mussels' recovery from environmental stressors, including acute heat shock and well-fed mussels exposed to sirtuin inhibitors and/or acute heat shock respond differently than poorly fed mussels, at the protein and whole-organism levels. While this implies a relationship between sirtuins, food availability, and temperature, the direct effects of sirtuin inhibitors (nicotinamide and suramin) on sirtuin activity or their putative effectors have not been explicitly tested. In this study, adult Mytilus californianus were acclimated to a low or high food availability and exposed to one of the following treatments: control, acute heat shock, sirtuin inhibitors, or acute heat shock and sirtuin inhibitors. Mussels increased sirtuin activity during early recovery (5 h) from sirtuin inhibition and acute heat shock, but only if acclimated to a high food availability. Redox balance was also impacted in mussels acclimated to high food availability and exposed to sirtuin inhibitors, signifying interactions between ration, acute heat shock, and sirtuin inhibitors. Additionally, we found a correlation between sirtuin and superoxide dismutase activities, suggesting a potential regulatory role of oxidative stress by sirtuins. Following prolonged recovery (17 h), we found increased sirtuin activity in mussels acclimated to low food availability, indicating that endogenous sirtuin activity may be related to food availability in mussels.

News (Medical) associated with Suramin Sodium

15 May 2024

·www.biospace.com

PaxMedica Files Nasdaq Delisting Appeal Notice and Prepares for Upcoming FDA Meeting on PAX-101

TARRYTOWN, New York, May 15, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica, Inc. (the “Company” or “PaxMedica”) (OTC:PXMD), a biopharmaceutical company dedicated to advancing treatments for neurological disorders, today announced it has timely filed a formal notice of appeal with the Nasdaq Office of Appeals and Review to reverse the decision of a Nasdaq Hearings Panel to delist the Company from Nasdaq. Following receipt of notification from Nasdaq on April 30th, PaxMedica determined to appeal the decision and intends to maintain that the Hearings Panel did not consider sufficiently or appropriately crucial aspects of PaxMedica’s recent achievements and ongoing actions to regain compliance with all applicable requirements for continued listing. PaxMedica has retained Jacob Frenkel, Dickinson Wright, PLLC as its lead counsel in the appeal, working with the consulting firm that interacted previously with the Hearings Panel. Howard Weisman, CEO of PaxMedica, commented, "We are seeking a reevaluation of Nasdaq’s recent action based on new developments that underscore our ongoing progress and commitment to addressing global health challenges. Notably, following our announcements on the completion of registration lots of PAX-101 in mid-April, the Company just submitted a briefing book for an important FDA Type C meeting scheduled for June 27th, during which we will present key updates on our plans for NDA submission later this year. We believe this, as well as our financing plans, which we made known to the Hearings Panel, support persuasively our arguments to appeal and restore trading on Nasdaq." Recent milestones for PaxMedica include: April 11th: Completion of three pivotal registration/validation batches of PAX-101, an IV formulation of suramin, crucial for ongoing regulatory submissions. April 16th: Receipt of an urgent request from Malawi’s Ministry of Health for emergency access to suramin to address a looming humanitarian crisis due to the scarcity of treatment for TBr HAT, a fatal form of African Sleeping Sickness. April 23rd: Agreement to supply Malawi with PAX-101 from our stock, reinforcing our role in combating global health emergencies. May 10th: PaxMedica submits FDA Briefing Book for June 27, 2024, Type C meeting. Weisman stated "these actions not only demonstrate our operational effectiveness, but also our vital role in the global healthcare landscape. We are encouraged that the upcoming FDA meeting, and our continuous efforts to supply life-saving treatments, will result in favorable consideration by Nasdaq in our appeal." Nevertheless, PaxMedica acknowledges that it cannot predict the outcome of the appeal. Weisman added that “we are committed to advancing expeditiously our efforts to maximize shareholder opportunities and value and pursue approval of our solutions for neurological disorders.” PaxMedica remains resolute in its mission to develop and provide innovative treatments for neurological disorders, ensuring significant contributions to public health worldwide. For more information on PaxMedica’s ongoing initiatives and developments, please visit . About PaxMedica PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) aimed at addressing a range of challenging neurologic disorders. Our comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), as well as other critical areas within the neurology field. Additionally, we intend to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense. We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions. To learn more about our transformative work, please visit Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at and by following PaxMedica on Twitter and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “could,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “propose,” “potential,” “continue” or similar expressions. These forward-looking statements include our anticipated clinical program, the timing and success of our anticipated data announcements, pre-clinical and clinical trials and regulatory filings, and distribution and demand for our product candidates. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development and clinical trials, risk of insufficient capital resources, cash funding and cash burn, regulatory approvals and risks associated with intellectual property and infringement claims. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results described in the Company’s “Risk Factors” section and other sections in its most recent Annual Report on Form 10-K, and subsequent quarterly and other filings with the U.S. Securities and Exchange Commission. Contacts PaxMedica, Inc. 303 S Broadway, Suite 125. Tarrytown, NY 10591 Media Contact media@paxmedica.com Investor Contact Scott McGowan InvestorBrandNetwork (IBN) Phone: 310.299.1717 ir@paxmedica.com SOURCE: PaxMedica, Inc.

10 May 2024

·www.sciencedaily.com

Metabolism of autism reveals developmental origins

Researchers have shed new light on the changes in metabolism that occur between birth and the presentation of autism spectrum disorder (ASD) later in childhood. The researchers discovered that a small number of biochemical pathways are responsible for the majority of these changes, which could help inform new early detection and prevention strategies for autism. Researchers at the University of California San Diego School of Medicine have shed new light on the changes in metabolism that occur between birth and the presentation of autism spectrum disorder (ASD) later in childhood. The researchers discovered that a small number of biochemical pathways are responsible for the majority of these changes, which could help inform new early detection and prevention strategies for autism. "At birth, the physical appearance and behavior of a child who will develop autism over the next few years are indistinguishable from that of a neurotypical child. Indeed, in most cases the fate of the child with regard to autism is not set at birth," said Robert Naviaux, M.D., Ph.D., professor in the Departments of Medicine, Pediatrics and Pathology at UC San Diego School of Medicine. "We're starting to learn about the governing dynamics that regulate the transition from risk to the actual appearance of the first symptoms of ASD. Early diagnosis opens the possibility of early intervention and optimal outcomes." ASD is a developmental disorder characterized by difficulties in socializing and communication, as well as repetitive and/or restrictive behaviors. For the majority of people with ASD, the condition is a significant disability, with only 10-20 percent of children diagnosed before 5 years of age able to live independently as adults. While autism is known to have strong genetic risk factors, there are also environmental risk factors that play a role in the development and severity of ASD. Naviaux and other researchers are discovering that the development of autism is governed by the real-time interaction of these varied factors. By studying the developmental biology of metabolism and how it differs in autism, new insights are emerging in ASD and other complex developmental disorders. "Behavior and metabolism are linked -- you cannot separate them," added Naviaux. To learn more about the early metabolic changes that occur in children with autism, researchers studied two cohorts of children. One cohort consisted of newborn children, in whom autism can't be detected. The second cohort consisted of 5-year-old children, some of whom had been diagnosed with autism. When comparing the metabolic profiles of children in the cohort who were eventually diagnosed with autism to those who developed neurotypically, they found striking differences. Of the 50 different biochemical pathways the researchers investigated, just 14 were responsible for 80 percent of the metabolic impact of autism. The pathways that were most changed are related to the cell danger response, a natural and universal cellular reaction to injury or metabolic stress. The body has biochemical safeguards in place that can shut down the cell danger response once the threat has passed, and Naviaux hypothesizes that autism occurs when these safeguards fail to develop normally. The result is heightened sensitivity to environmental stimuli, and this effect contributes to sensory sensitivities and other symptoms associated with autism. "Metabolism is the language that the brain, gut and immune system use to communicate, and autism occurs when the communication between these systems is changed," added Naviaux. The cell danger response is primarily regulated by adenosine triphosphate (ATP) the body's chemical energy currency. While these ATP-signaling pathways do not develop normally in autism, they may be partially restorable with existing pharmaceutical drugs. In 2017, Naviaux and his team completed early clinical testing for suramin, the only drug approved in humans that can target ATP signaling and which is normally used to treat African sleeping sickness. Now, the researchers hope that by revealing the specific ATP-related pathways that are altered in autism, their work will help scientists develop more drugs that target these pathways to manage the symptoms of ASD. "Suramin is just one drug that targets the cell danger response," he said. "Now that we're closely interrogating how metabolism changes in ASD, we could be at the beginning of a drug renaissance that will create new options for treatment that never existed before." Co-authors on the study include: Sai Sachin Lingampelly, Jane C. Naviaux, Jonathan M. Monk, Kefeng Li and Lin Wang at UC San Diego School of Medicine and Luke S. Heuer, Lori Haapanen, Chelsea A. Kelland and Judy Van de Water at University of California Davis This work was funded, in part, by Autism Speaks (grant 7274), the National Center for Research Resources (grant UL1TR001442), and through various philanthropic gifts.

Drug Approval

07 May 2024

·www.globenewswire.com

PaxMedica Provides Company Update and Continues to Advance PAX-101 Regulatory Strategy

TARRYTOWN, New York, May 07, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica, Inc. (OTC:PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, provided a corporate update in light of its transition off the NASDAQ stock market, emphasizing this change will not affect the company’s commitment to advancing treatments for neurological disorders. Howard Weisman, CEO of PaxMedica, affirmed, "Our determination to progress with the NDA submission for PAX-101 remains unaffected, as does our commitment to our clinical program to further explore the potential for anti-purinergic therapies to address the core symptoms of autism spectrum disorder (ASD)." The company is preparing to file a New Drug Application (NDA) with the FDA for the use of suramin in treating Human African Trypanosomiasis (HAT) as it has previously reported. Suramin has been recognized for nearly a century as a standard treatment for HAT in East Africa. In April 2024, PaxMedica responded to an urgent request from Malawi for an emergency release of suramin, underscoring the company’s commitment to addressing global health crises. "We are not just continuing; we are intensifying our efforts to achieve significant milestones for these programs by the end of this year," Weisman added. "We are on track to submit an NDA for PAX-101, and potentially secure an FDA Priority Review Voucher if approved." This proactive approach illustrates PaxMedica's dedication to advancing healthcare solutions globally. About PaxMedica PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) aimed at addressing a range of challenging neurologic disorders. Our comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), as well as other critical areas within the neurology field. Additionally, we intend to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense. We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions. To learn more about our transformative work, please visit www.paxmedica.com. Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.paxmedica.com/email-alerts and by following PaxMedica on Twitter and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “could,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “propose,” “potential,” “continue” or similar expressions. These forward-looking statements include our anticipated clinical program, the timing and success of our anticipated data announcements, pre-clinical and clinical trials and regulatory filings, and distribution and demand for our product candidates. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development and clinical trials, risk of insufficient capital resources, cash funding and cash burn, regulatory approvals and risks associated with intellectual property and infringement claims. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results described in the Company’s “Risk Factors” section and other sections in its most recent Annual Report on Form 10-K, and subsequent quarterly and other filings with the U.S. Securities and Exchange Commission. Contacts PaxMedica, Inc. 303 S Broadway, Suite 125. Tarrytown, NY 10591 www.paxmedica.com Media Contact media@paxmedica.com Investor Contact Scott McGowan InvestorBrandNetwork (IBN) Phone: 310.299.1717 ir@paxmedica.com www.paxmedica.com/investors SOURCE: PaxMedica, Inc.

NDAPriority Review

100 Deals associated with Suramin Sodium

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KEGG	Wiki	ATC	Drug Bank
-	Suramin Sodium	P01CX02	DB04786

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Onchocerciasis	DE	Bayer AG	01 Jan 1940
Trypanosomiasis, African	DE	Bayer AG	01 Jan 1940

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic cancer metastatic	Phase 3	US	National Cancer Institute	01 Oct 1996
Acute Kidney Injury	Phase 2	US	Rediscovery Life Sciences AKI LLCStartup	13 Nov 2020
Autism Spectrum Disorder	Phase 2	US	PaxMedica, Inc.	01 Jun 2019
Metastatic Renal Cell Carcinoma	Phase 2	US	National Cancer Institute	01 Mar 2004
Advanced breast cancer	Phase 2	US	National Cancer Institute	01 Dec 2002
Breast cancer recurrent	Phase 2	US	National Cancer Institute	01 Dec 2002
Metastatic breast cancer	Phase 2	US	National Cancer Institute	01 Dec 2002
metastatic non-small cell lung cancer	Phase 2	US	National Cancer Institute	01 Sep 2000
Non-small cell lung cancer stage IIIB	Phase 2	US	National Cancer Institute	01 Sep 2000
Recurrent Non-Small Cell Lung Cancer	Phase 2	US	National Cancer Institute	01 Sep 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01671332 (CTgov)	Phase 2	Advanced Lung Non-Small Cell Carcinoma	80	Docetaxel (Docetaxel)	fnxlizwvgv(gydwudkury) = kgcntvehxi reapyfpgyl (nyeuamalju, ltvlcjbiag - loopxpkanh) View more	-	12 May 2020
				Suramin+Docetaxel (Docetaxel Plus Suramin)	fnxlizwvgv(gydwudkury) = zoarezwdif reapyfpgyl (nyeuamalju, acurqmzdcq - fffproeakr) View more
NCT00054028 (CTgov)	Phase 1/2	Breast cancer recurrent \| Metastatic breast cancer \| Advanced breast cancer	31	pharmacological study+suramin+paclitaxel	kjgrrauvyh(oxdszqgqms) = szxjewezhw cdyewobdln (vlwvgvwkbx, hijfmghwde - gjkdxznqgq)	-	17 Mar 2015
NCT01038752 (CTgov)	Phase 2	Non-Small Cell Lung Cancer	14	Suramin Drug:Docetaxel Drug: Carboplatin (Suramin)	jeyewoeqzz(nynqooydzn) = uxgrhhsjxo blcrmalivl (fxcknhlqex, olgsqnqdko - vjlvlkqypj) View more	-	21 Oct 2014
				Placebo Drug: Docetaxel Drug: Carboplatin (Standard of Care)	jeyewoeqzz(nynqooydzn) = mrqxlfwabv blcrmalivl (fxcknhlqex, chthrltueg - svihfohiab) View more
ARVO2006	Not Applicable	Retinal Neovascularization P2X 2 \| P2Y 2	-	Suramin	fuhraknnsf(rdxfmwjxig) = oujjentdpx vwjinyksea (bgkqzgbffy )	Positive	01 May 2006
				Suramin	fuhraknnsf(rdxfmwjxig) = cqyszekhnx vwjinyksea (bgkqzgbffy )
ASCO2005	Phase 1	Non-Small Cell Lung Cancer	12	Docetaxel	tdyngobhrs(hnbuwnvyhk) = ztskbrwohz wnxungkvmj (iyausorpfa )	-	01 Jun 2005
ASCO2004	Phase 2	Non-Small Cell Lung Cancer	54	Low dose suramin	mmvyuuczns(ilswotmjqg) = pkggibjwui rfiygodwho (dtundvysrh, 22–54)	-	15 Jul 2004
NCT00004073 (NABTT CNS Consortium, Pubmed \| Neuro Oncol)	Phase 2	Glioblastoma	55	Suramin	qpvbtmoesr(vrhtuawzbr) = euffdgyoii znxadrfdhs (bznoogfaku )	Negative	01 Jan 2004
NCT00002723 (Intergroup 0159, Cancer and Leukemia Group B 9480, Pubmed \| J Urol)	Phase 3	Advanced Prostate Carcinoma	390	Low-dose suramin	terjpbxrvd(nqvhixwbqk) = zejiptnkzx igdcfiitlg (vnsjwhedmh ) View more	Negative	15 Aug 2002
				Intermediate-dose suramin	terjpbxrvd(nqvhixwbqk) = huvbqgvcze igdcfiitlg (vnsjwhedmh ) View more

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