Clinical Accelerator announces collaboration with Noxopharm to advance idronoxil (NOX66), a novel treatment for COVID-19

Clinical Accelerator is pleased to announce a new collaboration with Noxopharm, a leading Australian drug development company. Noxopharm’s NOX66 therapy has received trial approval and is now in a Phase Ib, open-label trial by Clinical Accelerator in Eastern Europe. The trial will evaluate the safety, tolerability and preliminary efficacy of NOX66 over a 4.5-fold dose-range in COVID-19 patients. We aim to establish the recommended Phase 2 dosage and also collect information on NOX66’s effect on several variables related to COVID-19 infection. For the study, the therapy is being given to hospitalized patients with moderate systemic illness due to COVID-19 infection at a high risk of developing severe sepsis/septic shock.

Idronoxil, the active ingredient in NOX66/Veyonda, is a multiple signal transduction regulator and immunomodulator via cancer specific inhibition of sphingosine1-phosphate and suppression of stimulator of interferon genes (STING)-mediated inflammatory cytokine pathways. In non-clinical studies, it has been shown that idronoxil can suppress a broad range of cytokines due to its capacity to strongly inhibit STING signalling, a cellular pathway associated with the onset of ‘cytokine storms’. Since COVID-19 patients can develop a ‘cytokine storm’ which may result in multiple organ failure and potentially death, is hypothesized that NOX66 can reduce this risk.

Another benefit of NOX66 is its potential to reduce  blood clotting events in COVID-19 patients, a condition that is being increasingly reported in some critically ill patients. This benefit is based on recent evidence which suggests that STING activation in immune cells may trigger aberrant blood coagulation.

Although many COVID-19 patients do not progress to severe disease, the frequency of severe disease in hospitalised patients in areas with significant community transmission can be as high as 30%. This highlights the urgent need for an effective therapy against this novel coronavirus-induced disease. We are hopeful that this trial can contribute to the discovery of a beneficial treatment for COVID-19 patients.

About Noxopharm

Noxopharm is an Australian clinical stage drug development company with a focus on developing a treatment for COVID-19 and also cancer. The company is run by a strong team of experts in the field including: CEO Graham Kelly; CMO Dr Gisela Mautner; COO Jeanette Bell; CFO Shawn Van Boheemen; CSO Dr John Wilkinson and Director of Drug Discovery and Research Olivier Laczka.

For more information, please see https://www.noxopharm.com/site/content/

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe, Russia, Ukraine and CIS countries. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological, nutraceutical and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.

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Axon Therapies Announces Positive Results From First-In-Human Clinical Study in Late-Breaking Clinical Trial Session At 2020 Virtual HFSA Conference

Below, we are re-publishing with permission the press-release issued by Axon Therapies, Inc. on October 09, 2020

Satera™ Ablation System demonstrates success as a frontline treatment of heart failure

Interim results from Axon Therapies’ First-in-Human Trial of the Satera Ablation System (11 HFpEF patients at 1- and 3-month follow-up)

NEW YORK, Oct. 9, 2020 /PRNewswire/ — Axon Therapies, a Coridea portfolio company focused on addressing one of the root causes of heart failure, today announced positive interim results from their first-in-human (FIH) trial of splanchnic ablation for volume management, or SAVM, using the Satera™ Ablation System.  Dr. Sanjiv Shah, Director of the HFpEF program at Northwestern University Feinberg School of Medicine in Chicago, IL presented the results during the Late Breaking Clinical Trial session at the annual Heart Failure Society of America (HFSA) meeting.

“As physicians, we are often limited in our ability to adequately decongest heart failure patients and prevent excessive increases in pressure during exertion. Although research has shown that inappropriate volume redistribution is a major contributor to functional limitations and outcomes, no interventions targeting this mechanism have existed until now,” stated cardiologist Dr. Sanjiv Shah.  “I’m very excited about the positive first-in-human results from Axon’s innovative ablation technology. The SAVM procedure selectively blocks the neural pathway carrying signals from the chronically active sympathetic system to the splanchnic vascular bed, causing selective venodilation, improved venous compliance, and ultimately restoring appropriate volume balance within the circulation.”

A total of 11 heart failure patients with preserved ejection fraction (HFpEF) were successfully treated using Axon’s Satera™ Ablation System. Interim data was presented on 1- and 3-month follow-up post-procedure. Endpoints included a composite safety index, New York Heart Association (NYHA) Heart Failure classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and 6-minute walk test.

Study highlights include:

  • Achieved procedural success in all 11 patients with no device or procedural-related serious adverse events (SAEs)
  • Significant improvement in NYHA classification (p<0.05) at both 1-month and 3-month follow-up
  • Significant improvement in KCCQ score (p<0.05) at both 1-month (43 vs. 64) and 3-month (43 vs. 79) follow-up
  • Significant improvement in 6-minute walk test (p<0.05) at both 1-month (293 vs. 342 meters) and 3-month (293 vs. 347 meters) follow-up
  • Significant reduction in NT-proBNP (p<0.05) at 3-month (1,292 vs. 627 pg/mL) follow-up

Building on the FIH results, Axon is initiating REBALANCE-HF, a prospective, randomized, sham controlled, double-blinded feasibility IDE trial in early 2021. The study will enroll 80 patients at up to 20 sites to assess the safety and efficacy of SAVM using the Satera Ablation System in HFpEF patients. Learn more at www.axontherapies.com.

“The SAVM procedure is a frontline heart failure therapy that restores volume balance, stops disease progression and improves outcomes in heart failure patients,” commented Howard Levin MD, CEO of Axon Therapies. “In addition, the outpatient, transvenous procedure is implant-free, which preserves future options for the patient. We are initially focusing on the underserved HFpEF patient population, but believe SAVM, with the Satera Ablation System, may have applications for all heart failure patients in the future.” 

About Axon Therapies, Inc.
Axon Therapies, a portfolio company of proven medtech incubator Coridea, is focused on solutions to address one of the root causes of heart failure. Developed from a known surgical procedure, splanchnic ablation for volume management (SAVM) using the Satera™ Ablation System enables selective and sustained venodilation of the splanchnic bed. During the procedure the right greater splanchnic nerve is ablated and signals to the chronically hyperactive sympathetic nervous system (SNS) are disrupted. This allows the body to restore normal volume balance, stop disease progression and improve symptoms in heart failure patients. Learn more at axontherapies.com.

*The study is conducted by Clinical Accelerator

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Sequana Medical announces strong interim results from RED DESERT alfapump® DSR study and provides business update

Below, we are re-publishing with permission the press-release issued by Sequana Medical on October 22, 2020

RED DESERT:
 Results from first five patients indicate repeated dose alfa
pump DSR therapy to be safe and effective
 Interim data support DSR hypothesis: kidneys eliminate free water to maintain patients’ serum sodium levels
 No patients required loop diuretic therapy during the six-week alfa
pump DSR treatment period
 Following alfa
pump DSR treatment, loop diuretic responsiveness was restored to near normal levels; effect was durable for months post-treatment with majority of patients requiring little or no diuretic therapy
 Full RED DESERT data on track to report in H1 2021; first feasibility study (SAHARA DESERT) planned to start in H1 2021

BUSINESS UPDATE:
 Early interim data from POSEIDON study in recurrent and refractory liver ascites expected in Q4 2020
 European commercial supply of the alfa
pump temporarily interrupted in Q4 2020; no impact on POSEIDON and RED DESERT studies

Ghent, BELGIUM – 22 October 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces positive interim results from the first five patients enrolled in the RED DESERT study, evaluating repeated dose treatment of alfapump DSR (Direct Sodium Removal) in diuretic-resistant heart failure patients. Sequana Medical also provides a business update.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are hugely excited by these results from the first five RED DESERT patients and believe it is the first time ever that fluid balance in heart failure patients has been managed using repeated dose DSR therapy without the need for diuretics. These data support the underlying principle of DSR that after we remove sodium, the body will step in to quickly and accurately remove the free water necessary to restore the serum sodium concentration. Not only does these data suggest that by using alfapump DSR, we can manage the fluid and sodium balance of these patients, but also the restoration of diuretic response opens up further potential opportunities such as renal failure and haemodialysis. Following the allowance of our key patents in both the U.S. and Europe, we are confident that we will continue to lead the way in the use of alfapump DSR for the management of volume overload in a range of indications.”

Five heart failure patients (mean left ventricle ejection fraction in mid-20%’s and mean NT-proBNP of 2,500 – 3,000 pg/mL) on high dose diuretics (average furosemide equivalent dose of 150 – 200mg per day) underwent up to six weeks of alfapump DSR treatment. The alfapump DSR implant procedure and repeated dosing of DSR therapy were well tolerated in all patients with few adverse events.

There were no clinically significant changes in serum sodium levels or progressive hyponatremia (low concentration of sodium in the blood) in these patients after repeated DSR dosing. The results also show that during the course of the six-week therapy, no loop diuretics were required, demonstrating the ability of the alfapump DSR system to effectively remove sodium and fluid from these patients. Moreover, in the majority of patients, reduced doses of DSR therapy could be utilised and / or some DSR doses could be omitted while maintaining stable to lower weight and natriuretic peptides compared to baseline.

Restoration of diuretic response is an exploratory endpoint of RED DESERT, which is determined by the six-hour excretion of fluid and sodium following intravenous administration of 40mg of furosemide, evaluated serially throughout the study. All patients had an objectively poor diuretic response at baseline. After the six-week study, the diuretic response was restored to near normal levels with the six-hour sodium excretion more than doubled versus baseline. Furthermore, there was a significant durability to the improvement in diuretic responsiveness; in the majority of patients there was a dramatic reduction in loop diuretic requirements lasting months following the completion of alfapump DSR therapy.

“Diuretic-resistance is a nearly ubiquitous problem in heart failure patients resulting in untreated volume overload and high rates of hospitalisation. The results from these first five patients in the RED DESERT study are very promising and point to the potential use of the alfapump DSR in this difficult to treat patient population that has a clear unmet need,” said Dr. Jozef Bartunek, Interventional Cardiologist at Onze-Lieve-Vrouw Hospital in Aalst (Belgium) and Principal Investigator of the RED DESERT study.

“The durable improvement in diuretic responsiveness is particularly interesting. With additional confirmation of these encouraging results through continued study, I believe alfapump DSR has the potential to become a new therapy for the management of volume overload and diuretic resistance,” added Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor of Sequana Medical.

The RED DESERT study will enrol up to five additional patients, with top-line data expected in H1 2021.

Following the highly encouraging impact on diuretic responsiveness shown by the RED DESERT interim data, Sequana Medical plans to evaluate the dosing and frequency of alfapump DSR therapy in decompensated heart failure patients with residual congestion in a first feasibility study (SAHARA DESERT), expected to start in H1 2021. Based on the results of SAHARA DESERT, and other studies, Sequana Medical intends to commence a U.S. feasibility study in mid-2022 using a next generation proprietary DSR infusate comparing alfapump DSR therapy to standard of care.

Early interim data from POSEIDON study expected in Q4 2020

Since data on the first 13 roll-in patients will soon be available, Sequana Medical will provide an update with early interim data for POSEIDON later this quarter. Interim data of the full roll-in cohort are expected in H1 2021 and primary endpoint read-out of the study cohort is expected in Q1 2022.

Update on alfapump manufacturing

As a result of problems with supply of a sub-component of the alfapump, Sequana Medical prioritised the supply of alfapump systems for the clinical studies and as such encounters a temporarily delay in the supply of the alfapump to commercial markets in Europe during Q4 2020. This is only temporarily impacting European commercial availability and the alfapump continues to be available for the POSEIDON and RED DESERT clinical studies. There is no impact on the quality of the alfapump system that has been supplied to the market and there is no regulatory impact. Normal supply is expected to return for Q1 2021.

About RED DESERT – Repeated dose alfapump DSR study for treatment of diuretic-resistant heart failure patients
This study is a multi-centre, prospective, single-arm, first-in-human study to evaluate the safety and feasibility of alfapump DSR. Up to 10 patients diagnosed with stable chronic heart failure on high dose oral diuretics are implanted with the alfapump DSR system (alfapump and implanted surgical port) across two centres in Belgium (Dr Bartunek at Cardiovascular Center Aalst) and Georgia (Dr Shaburishvili at Heart and Vascular Clinic Tbilisi). Following alfapump DSR system implantation, patients undergo a diuretic challenge with timed biospecimen collection. On day 14 post-implant (day 0), the patient is admitted for a 14-day in-patient period in which diuretics are withheld and patients are put on a strict low-sodium diet. During the first 14 days, patients are treated with DSR D10% infusate on Monday, Wednesday and Friday, administered through the implanted surgical port into the peritoneal cavity. The DSR infusate remains in the peritoneal cavity for a two-hour dwell time, after which all fluid is eliminated from the peritoneal cavity through the bladder using the alfapump system. Following the 14-day in-patient period, patients undergo a second diuretic challenge. Thereafter, diuretics continue to be withheld and patients come into the clinic for their DSR therapy over the subsequent four weeks. After completion of the study period, patients undergo a third diuretic challenge to quantify their response to diuretics.

The primary safety endpoints include absence of device, procedure and/or therapy related serious adverse events through day 14 and the rate of device, procedure and/or therapy related serious adverse event through day 42. Secondary feasibility endpoints include the ability of alfapump DSR to maintain a neutral sodium balance in the absence of diuretic therapy and the sustained effect of DSR to maintain euvolemia through week 6. Additional exploratory endpoints evaluate the potential impact of DSR to restore response to diuretics following DSR therapy. For more information about the study, please visit clinicaltrials.gov (NCT04116034).

About alfapump DSR (Direct Sodium Removal)
alfapump DSR is in clinical development as potential chronic therapy for patients with volume overload due to heart failure. Volume overload in heart failure is a major clinical problem and is the leading cause of hospitalisations for patients with heart failure. There are approximately one million hospitalisations for heart failure annually in the U.S. and 90% are due to symptoms of volume overload. The treatment options are severely limited in those patients for whom diuretic therapy is no longer effective. This limitation is evident from the 24% hospital re-admission rate at 30 days from discharge. The estimated cost of heart failure-related hospitalisations in the U.S. alone is $13 billion per year.

DSR therapy is a breakthrough approach that involves removing sodium from the body using diffusion via the peritoneal cavity with the use of a sodium-free solution known as DSR infusate. Once the sodium has been removed, the body eliminates excess fluid naturally through urination. Studies have demonstrated that DSR therapy is capable of removing large quantities of sodium and fluid in a safe, tolerable and consistent manner and results were published in the high impact cardiovascular journal, Circulation.

About Sequana Medical
Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a fast growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.

In the U.S., the company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent and refractory ascites due to liver cirrhosis is currently underway, and is intended to support a commercial marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 800 alfapump systems have been implanted to date. Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump DSR study (RED DESERT) in heart failure patients is currently underway.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers
The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see http://www.poseidonstudy.com. The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.

Forward-looking statements
This press release may contain predictions, estimates or other information that might be considered forwardlooking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

* In Georgia the study is conducted by Clinical Accelerator

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Clinical Accelerator to collaborate with Second Heart Assist on a Phase I study in Heart Failure

Clinical Accelerator and Second Heart Assist have recently entered into an exciting new collaboration, focused on developing a novel device for heart failure patients. An early feasibility trial will be conducted on Second Heart’s aortic stent based circulatory assist pump. The company is developing both a temporary use catheter-based device and a wireless powered chronic implant. The objective is to improve quality of life of heart failure patients by reducing the heart’s workload and improving organ perfusion. Renal function is also expected to be enhanced which reduces the risks that come with toxic contrasts used in percutaneous catheterization interventions (High Risk PCI). The product will also help patients to recover from cardiogenic shock and attain normal hemodynamics for acute decompensating heart failure patients.

Heart Failure is a severe problem that currently affects over 6 million people in the U.S. alone. Many patients cannot receive a heart transplant and therefore are instead reliant on cardiac assist devices. A major issue is that currently available circulatory assist devices have limitations such as device-associated thrombosis, and there are also risks and complications that can come with invasive implantation procedures that are often needed for many devices. Second Heart’s technology overcomes many of the limitations that are associated with other devices as it involves easy and secure placement in the aorta, provides high flow rates and minimizes risk of thrombosis with thrombosis-resistant material. The aortic stent design in this device is also currently the only one that is known to combine both high security of fixation stability and also maintenance of pulsatile aortic wall movement (which can potentially be essential to successful long-term chronic implant)

About Second Heart Assist

Second Heart Assist is a development stage company dedicated to developing the world’s first percutaneously placed true aortic stent based circulatory assist pumps. The company has two advanced platforms for three cardiovascular clinical endpoints and markets: (PCI, CRS, Class III HF). The platforms are a catheter-based device and a wireless power chronic device, both of which utilize their pulsatile-conforming aortic radial stent. Second Heart Assist is part of Leonhardt Ventures – a venture creation lab focused on advancing regenerative medtech innovations. It was founded by Howard J. Leonhardt, inventor and serial entrepreneur who has 21 U.S. patents and over 100 patent claims for products treating cardiovascular disease. Supervising the project is Dr. Les Miller, a prominent heart failure cardiologist and CMO of Second Heart Assist.

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.

 

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Clinical Accelerator announces collaboration with LARRK Bio Inc

Clinical Accelerator is excited to announce that it has entered into a collaboration with LARRK Bio Inc, a US based biotech start-up company focusing on skin health and dermatology. The company is currently in “stealth mode”. LARRK Bio is led by Frederic Godderis, an experienced Pharma/Biotech executive and entrepreneur.

Clinical Accelerator has been conducting studies in the field of dermatology for over 10 years and has accumulated experience in many dermatologic indications, including: psoriasis; atopic dermatitis; skin cancer; burns and wounds. Our studies are placed in Central and Eastern Europe where we have extensive knowledge of specialist dermatology sites. Features of our sites include good access to patients and fast speed of patient enrolment. Members of our network of dermatologist are able to pre-screen and identify patients with all major dermatology conditions and refer them for enrolment into clinical trials at the selected specialist dermatology sites.

As a clinical CRO, Clinical Accelerator offers a full range of clinical trial services from protocol development and regulatory affairs through clinical conduct to data management, biostatistics and study reporting. As a patient enrolment organization, our strongest focus is on fast and efficient patient enrolment into our projects. Working closely with our network of investigators, we have developed an enhanced model of patient enrolment which allows us to accelerate clinical trials of any complexity and routinely rescue delayed and stalled studies.

We are looking forward to a productive collaboration with LARRK Bio and the successful completion of the trials under this agreement.

 

About Clinical Accelerator

Clinical Accelerator is a boutique clinical CRO, working predominantly with emerging Biotech and MedTech companies. The company has been running clinical studies in all main therapeutic areas, including dermatology, for over 14 years. Clinical Accelerator implements clinical studies in Central and Eastern Europe in a close collaboration with a fast-growing network of investigators who provide access to large patient populations in all main therapeutic areas.  The company is intent on fast and efficient patient enrolment even into most difficult clinical studies. Clinical Accelerator often participates in projects with patient enrolment challenges and routinely rescues delayed and stalled clinical trials.

Posted in Biotech, Central and Eastern Europe, Clinical Accelerator | Leave a comment

Replicor announces publication of the REP 401 study achieving high rates of virologic control and functional cure in patients with chronic hepatitis B infection

Below, we are re-publishing with permission the press-release issued by Replicor Inc. on March 09, 2020

MONTREAL, March 9, 2020 – Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced the publication of the final results of its latest REP 401 study in the prestigious journal Gastroenterology.

The article, entitled “Safety and Efficacy of 48 Weeks REP 2139 or REP 2165, Tenofovir Disoproxil, and Pegylated Interferon Alfa-2a in Patients With Chronic HBV Infection Naïve to Nucleos(t)ide Therapy”, presents the analysis of the safety and efficacy of NAP therapy when added to a backbone of TDF and pegIFN in patients with treatment naïve chronic HBV infection.

The culmination of more than a decade of clinical investigation of NAPs, transitioning from REP 2055 to REP 2139-Mg, the REP 401 study achieved dramatic increases in the incidence of HBsAg loss and seroconversion during therapy (60%) and therapeutic transaminase flares (95%) compared to that observed with TDF + pegIFN alone. Importantly 78% of participants achieved virologic control of HBV of whom 39% further achieved functional cure. These outcomes dramatically improve those achieved by TDF + pegIFN alone and far exceed those observed with any other therapy currently in development in mono or combination therapy.

r. Andrew Vaillant, CSO of Replicor commented, “Our substantial body of published data clearly demonstrates that all NAPs using Replicor’s proprietary poly AC technology have very similar activity with similar doses required in humans. However, only NAPs formulated as magnesium chelate complexes such as REP 2139-Mg and REP 2165-Mg have the excellent tolerability and safety required for use with immunotherapy. This combination approach is essential to awaken an effective immune response capable of driving high rates of therapeutic transaminase flares essential for restoring virologic control and functional cure. The successful completion of the REP 401 study paves the way for the long-planned transition of REP 2139-Mg to subcutaneous administration and assessment in combination with other immunotherapies capable of driving HBsAg specific T-cell activation, an activity we believe is a critical component of achieving functional cure.”

The article can be accessed directly at the following link:
https://www.gastrojournal.org/article/S0016-5085(20)30320-6/fulltext

About Replicor
Replicor is a privately held biopharmaceutical company with the most advanced animal and human clinical data in the development of the cure for HBV and HDV. The company is dedicated to accelerating the development of an effective treatment for patients with HBV and HBV/HDV co-infection. For further information about Replicor please visit our website at http://www.replicor.com.

* The study is conducted by Clinical Accelerator

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Second Heart Assist Announces Successful Completion of Long-Duration Pre-Clinical Studies

Below, we are re-publishing with permission the press-release issued by Second Heart Assist Inc. on June 22, 2020

Salt Lake City, Utah, June 22nd, 2020 /PRDistribution/ — Second Heart Assist Inc., inventors of the first, true, aortic stent-based circulatory assist pump intended primarily for use in heart failure patients, announces the successful completion of a series of long-duration preclinical studies in pulsatile mock loop and bovine models. Long-duration studies were completed using mock-loop apparatuses at the University of Louisville (Louisville, KY), ViVitro Labs (Victoria, BC, Canada), and Biomerics (Minneapolis, MN) as well as in large animal models at Q Test (Columbus, OH), APS (Minneapolis, MN) and the Texas Heart Institute (Houston, TX). These successful studies pave the way for upcoming, first-in-human clinical studies in diuretic resistant heart failure patients suffering from cardio-renal syndrome—to be performed in Tbilisi, Georgia in July 2020. It is planned that OUS first-in-human studies will be followed by a US-based Early Feasibility Study (EFS).

“The recent successful completion of these long-duration in vivo studies, utilizing the percutaneously delivered Second Heart Assist circulatory assist pump within a true aortic stent, demonstrates the desired durability needed to address an increasing patient population suffering from advanced heart failure.” stated Alex Richardson, Chief Technology Officer and Vice President of Engineering Second Heart Assist, Inc. who was present and actively participated in all preclinical studies. “These preclinical studies demonstrated position stability and robust blood flow improvement provided by our system. We are particularly excited about the excellent outcomes we saw during long-duration studies where we noted minimal hemolysis and only minor clinically insignificant thrombus formation after over 40 hours of operation.” Richardson further stated, “These studies, again, give evidence to the advantages of the unique design for our catheter-based product. Furthermore, we have adapted this same mechanical stent and impeller pump platform for use in our chronic wireless device, which we are actively building and testing, to target additional therapeutic endpoints.”

“The Second Heart Assist product lineup introduces a unique solution for patients suffering from diuretic resistance resulting in cardio-renal syndrome by providing strong improvements to renal function, while offloading the heart. The strong radial force of the aortic stent minimizes risk of migration experienced by other available device designs.” stated Jeff Donofrio President, who was present for the Texas Heart Institute study.

Dr. Brett Burton, VP of R&D at Second Heart Assist, explained: “Our device is unique in that it not only occupies the entire aorta, but it is also designed to safely distend the vessel by about 2 mm. This design ensures that, once properly positioned and deployed, our device maintains a robust intervascular fixation within the aorta (just above the renal arteries).  In addition to secure device positioning, the large cross-sectional area produced by the open stent allows for the unimpeded flow of blood within the vessel and provides a space in which our impeller can operate safely, effectively, and, at low RPMs, to generate high flow to the renal arteries.”

Dr. Leslie Miller, Chief Medical Officer (CMO) of Second Heart Assist commented, “We are thrilled to have reached this milestone, which further validates the safety and efficacy of our technology, particularly in preclinical settings, and supports our intent to now move into longer duration clinical studies.”

Dr. Mark Cunningham, Chief Cardiac Surgery Advisor, Board Director, and Cardiac Surgeon at USC Keck Medical Center, and who also assisted in the recent 40+ hour Texas Heart Institute study, stated “I see patients every week, including those receiving ineffective inotropic support (of which decreased renal function is a characteristic). Many of these patients could benefit greatly from the Second Heart Assist circulatory assist pump, designed to deliver continuous and reliable renal support while maintaining consistent positioning through its aortic stent technology platform. The 2nd generation wireless powered chronic implant in development represents a potentially huge leap forward.”

Clinical Accelerator, Inc. has been engaged as the Contract Research Organization (CRO) to help implement the OUS cardio-renal syndrome heart failure clinical study including data collection and analysis – https://clinicalaccelerator.com/cro-services/

In 2019 the Second Heart Assist team previously announced results from a positive short-duration pilot first-in-human clinical study – https://secondheartinc.com/second-heart-assist-announces-landmark-successful-first-in-human-non-surgical-placement-of-an-aortic-stent-based-circulatory-assist-pump/. This clinical data has been presented at the Heart Failure Society of America, TCT Cardiology, Devices for Heart Failure and ASAIO Annual Meetings.

The team also announced recent progress on the development of its wireless powered chronic product-https://secondheartinc.com/second-heart-assist-to-unveil-updated-wireless-power-design-at-asaio-annual-meeting/

About Second Heart Assist: 

Second Heart Assist, Inc. is a Utah corporation founded in 2016 focused on development of a circulatory assist pump within an aortic stent within the Leonhardt’s Launchpads www.leonhardtventures.com innovation and startup accelerator(s). See www.secondheartinc.com for more information.

Disclaimer: Forward looking information is subject to change without notice. Product is not yet proven to be safe or effective. Product is still in early stage of development and pathway to commercialization. The company lacks sufficient resources at this time to bring product to commercialization. Patents pending may not be issued. Patents issued may be invalidated. Patents optioned or licensed may not be maintained. As an investment Second Heart Assist must be regarded in highest risk category for total loss. No other group has succeeded in developing a wireless power chronic circulatory assist device with success as the obstacles to doing so are tremendous. Available for investigational use only in locations where proper regulatory clearance has been granted.

* The study is conducted by Clinical Accelerator

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Clinical Accelerator collaborates with CroíValve on a study for Tricuspid Regurgitation

 

Clinical Accelerator has recently entered into a new collaboration with CroíValve – a medical device company from Ireland – who is developing a novel, easy to use percutaneous solution for treating patients with severe Tricuspid Regurgitation (TR).

Tricuspid Regurgitation is an unmet medical need that affects over 550 thousand new patients every year in the US and EU alone. It often occurs in heart failure patients due to tricuspid annular dilation. Prognosis is poor for those affected and less than 1% of patients can undergo surgical treatment due to co-morbidities. Even for patients who can receive treatment, the operative mortality rate is between 10% to 35%.

Croívalve is dedicated to bringing an innovative solution to this area with their minimally invasive device that repairs the tricuspid valve without requiring surgery. The device will be placed across the native valve assisting coaptation and is held in place by a non-penetrating anchoring system. The device intends to provide patients with improved and extended quality of life and physicians with safe and easy treatment.

Croívalve announced first successful human use of its technology in March this year. The procedure was carried out at St James’ Hospital (Dublin, Ireland) and involved delivery and retrieval of the device fully percutaneously, with the device delivered without complications in the space of five minutes. It was published that the patient who suffered from severe TR with reduced heart function, experienced positive cardiac response to the treatment (Innovator, 2020).

Clinical Accelerator is excited to be participating in a new clinical study by Croívalve assessing the feasibility, safety and performance of temporary implantation of the device in TR patients prior to surgical intervention.

About CroíValve

Croívalve is an early stage medical device company focused on developing a minimally invasive device for the treatment of tricuspid regurgitation. It is based in Dublin, Ireland and combines significant clinical, technical and commercial experience.

https://www.croivalve.com/

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.

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Clinical Accelerator continues its collaboration with Sequana Medical, a medical device company developing the alfapump DSR System for the treatment of Diuretic Resistant Heart Failure

Clinical Accelerator, a full-service contract research organization with a strong focus on medical device investigations, is pleased to report that despite the global disruption caused by Covid-19, work has been continued in the Republic of Georgia on RED DESERT – Repeated Dose alfapump DSR study for Treatment of diuretic-resistant heart failure patients. The study is sponsored by Sequana Medical, an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure.

Sequana Medical was founded in 2006 with the initial aim of finding a better way to manage ascites patients. The company has developed and commercialised the alfapump in Europe, a fully implantable, programmable, wirelessly-charged, battery-powered system that is CE-marked for the treatment of refractory ascites due to liver cirrhosis and malignant ascites. In the U.S., the alfapump received Breakthrough Device designation for recurrent or refractory ascites due to liver cirrhosis and Sequana Medical is currently running the North American pivotal POSEIDON study to support FDA approval. Over 750 alfapump systems have been implanted to date.

The company is now extending the application of its unique technology to a new indication – management of volume overload in heart failure patients. The new device is called alfapump DSR (Direct Sodium Removal). This innovative therapy is being developed in collaboration with Dr Jeffrey Testani, Associate Professor at Yale University. The results of the FIH single dose DSR study, conducted by Dr Testani were presented at the Heart Failure 2019 Congress and published in Circulation.

Sequana Medical’s alfapump DSR system involves the use of the peritoneal cavity for the removal of excess sodium via diffusion. The system comprises of i) the alfapump a fully implanted subcutaneous device with a rechargeable battery that moves fluid from the peritoneal cavity to the urinary bladder where it is eliminated and ii) an implantable peritoneal catheter port. The DSR System is used in conjunction with the DSR infusate (zero sodium peritoneal solution, 10% dextrose in sterile water), which is instilled into the peritoneal cavity and left to dwell for a period of 2 hours.

The ongoing study is a prospective, single-arm, repeated dose study and is expected to include up to 10 heart failure patients, who are on high dose diuretics, across two centres in Belgium and Georgia. The primary safety endpoints include the rate of device, procedure and/or therapy-related serious adverse events after two and six weeks. The secondary endpoints include the feasibility of alfapump DSR to remove excess sodium and fluid from the body, thereby eliminating the need for daily high dose diuretics during the six-week treatment period. Additional exploratory endpoints to measure the potential impact of DSR therapy to restore response to diuretics will be evaluated through week six.

About Sequana Medical

Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure. Fluid overload is a fast-growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billon annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers

The alfapump® system is not currently approved in the United States or Canada.  In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis.  For more information regarding the POSEIDON clinical study see www.poseidon.com .

The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed.

The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.

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Clinical Accelerator and BetaGlue Technologies to conduct First in Human Medical Device Investigations in Breast Cancer and Liver Cancer

Clinical Accelerator is pleased to announce an exciting new collaboration with BetaGlue Technologies SpA. Two studies will be conducted, one on radio-ablation of surgical margins following resection of breast ductal carcinoma in situ (DCIS), in 20 patients and one of radio-ablation of malignant liver lesions – hepato-cellular carcinoma (HCC) – followed by surgical resection, in 10 patients.

Currently, surgery is the standard of care for resectable solid tumours. Loco-regional approaches combined with chemotherapy and/or radiotherapy are the standard therapy either before surgery to reduce tumoral mass or after surgery to reduce the risk of recurrence. Unfortunately, local recurrences and other complications are still a problem that needs to be remedied. BetaGlue, focusing specifically on these unmet needs and has developed a proprietary internal radiotherapy platform, composed of a 90Y β-emitting radioactive hydrogel matrix which has several clinical applications. Several administration devices have also been engineered or are in development for precise delivery and administration of this radio-active matrix.

The administration of β-emitting radionuclides has several advantages over external radiotherapy. There is improved efficacy, low impact on blood vessels, limited side effects and low surrounding tissue penetration. On the basis of the clinical experience accumulated in over 15 years of treatments based on trans-arterial infusion of 90Y-coated microspheres (Selective Internal Radio Therapy, SIRT, called also Trans Arterial Radio Embolization, TARE), it is reasonable to assume that the intra-tumoral injection of a personalized activity dose of 90Y, entrapped inside the matrix and directly into the hepato-cellular carcinomas, is expected to effectively ablate them and to reduce drastically the chances of local recurrence. Similarly, the administration of the appropriate activity of 90Y in the surgical bed of resected breast tumours should overcome the limitation of other radiotherapy techniques (intra-operative and/or external beam radiotherapy) and reduce drastically their chance of local recurrence, which occurs in the area of tumor resection in 95% of the cases.

The upcoming studies have the potential to pave the road for confirming the efficacy and safety of these applications. In breast cancer, after the cancerous region is removed, residual tumour cells are often left behind in the surgical bed. As part of the DCIS study, BetaGlue’s technology will be uniformly applied over the tumour bed, expectedly killing any residual tumoral cells through beta radiation. In the liver cancer study, once the tumour is identified, an introducer will be placed percutaneously into it and, through a proprietary delivery system, BetaGlue’s radioactive compound will be injected into the hepatic lesions, killing the tumoral cells. In both applications, once the radioactive charge is exhausted, the body will slowly reabsorb the bio-compatible matrix over time.

 About BetaGlue Technologies

 BetaGlue is a medical device company, founded in 2017 in Milano, Italy. Dr Antonino Amato CEO, Dr Pier Luigi Carriero, VP Clinical Operations and their team are dedicated to providing an innovative approach to fighting cancer with their proprietary β-emitting bio-compatible matrix, delivered through dedicated delivery systems. The company is supported by a highly qualified Scientific Advisory Board, and national/international consultants on intellectual property, product development and regulatory expertise.

 https://www.betaglue.com/

  About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech and Biotech companies. The organization conducts clinical trials in all main indications, with oncology being an important therapeutic area. Clinical Accelerator works with many excellent sites and investigators in Central and Eastern Europe, experienced in international clinical trials in the oncology field. The company offers clients a range of clinical trial services, including designing essential study documents, regulatory and ethics submissions, site selection and monitoring, safety reporting and medical monitoring, data management and biostatistics, medical writing and quality assurance.

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