Clinical Accelerator collaborates with Thrombolytic Science International to study a tPA/mutant pro-urokinase dual regimen for thrombolysis in acute myocardial infarction

Clinical Accelerator, a full-service contract research organization, has entered into a collaboration with Thrombolytic Science International (TSI) to conduct a phase II randomised, multi-centre, open-label, parallel group mechanistic study using TSI’s dual treatment regimen in patients with ST elevation myocardial infarction (STEMI).

The purpose of this clinical trial is to affirm the safety and efficacy of sequential thrombolytic therapy with mutant pro-urokinase and low dose tissue plasminogen activator (tPA) as a potentially safe, simple and early reperfusion treatment for STEMI in comparison with standard of care percutaneous coronary intervention.

TSI’s thrombolytic treatment regimen is based on the endogenous human fibrinolytic system. It uses a low dose of tPA, the approved thrombolytic agent, followed by mutant pro-urokinase, a more stable and safer version of well-studied thrombolytic, pro-urokinase (proUK).

The dual regimen concept was validated in the phase II trial PATENT trial, which showed that a dual treatment of tPA and proUK was more effective and safer than either activator alone.

This novel treatment with mutant proUK is based on the pioneering work of Dr Victor Gurewich, Professor of Medicine at Harvard Medical School, a researcher and a TSI co-founder.

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Clinical Accelerator announces collaboration with Nasaleze International Ltd for a clinical study of Nasafort- a fast acting nasal spray for allergic rhinitis

Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Nasaleze International Limited, for conducting a pivotal study for Nasafort: a nasally applied cellulose powder in seasonal allergic rhinitis (SAR) in adults with grass pollen allergy during 4 weeks of the pollen season. It will be a randomized, double-blind, placebo-controlled and multi-center medical device investigation conducted in Ukraine.

Allergic rhinitis is a very common chronic condition affecting 65 million people in the United States. Although the condition is minor medically, the symptoms are troublesome. A range of treatments and remedies are available on prescription and over the counter, but nasal steroid sprays are considered the most effective. There is however a need for greater palliative treatment of allergic rhinitis and better prevention.

Nasafort is sold in Europe as a Class 1 medical device for managing hay fever. It is applied in the nostrils via a patented puffer device. When the bottle is squeezed, a puff of fine cellulose powder (Hydroxypropyl methylcellulose (HPMC)) is released into the nose and reacts with moisture on the mucous membrane to form a gel layer. This layer acts as a barrier between the nose and allergy particle in the air, thus blocking them.

Previous studies have shown its efficacy in the absence of any clinically significant adverse effects. The purpose of this pivotal study is to obtain additional evidence of the efficacy and safety of Nasafort in adult patients with SAR aged 18 to 40 years old with SAR to grass pollen.

About Nasaleze Ltd.

Nasaleze International Limited is an Isle of Man based medical device company which has developed Nasafort (also known as Nasaleze and other trade names), a fast-acting nasal spray for the treatment of allergic rhinitis.  It is currently available in Boots, under the name of Boots Allergy Barrier in the United Kingdom, other countries where the product is sold, United States, Russia, China, France, Germany, Sweden, Netherlands, India, Korea and 15 + other countries.  Nasaleze is registered with FDA in the USA.

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological and medical device industries.

Clinical Accelerator employs a cost-effective model of conducting clinical trials with a special focus on their accelerated implementation. The ultimate goal is to bring much needed pharmaceutical products and medical devices to the market faster.

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VisCardia Announces Completion of Enrollment and Three Month Follow-Up Visits for Its VisONE® Heart Failure Pilot Study

Below, we are re-publishing with permission the press-release issued by VisCardia Inc. on April 22, 2019

PORTLAND, Ore.–(BUSINESS WIRE)–VisCardia Inc., a privately held medical device developer, announced today it has completed enrollment and three month follow-up visits of the company’s VisONE® implantable system pilot for medical refractory heart failure patients with reduced ejection fraction and preserved ventricular synchrony.

“VisONE provides an innovative and unique approach for improving cardiac performance in medical refractory heart failure patients who currently have no alternative treatment options”

The VisONE Heart Failure pilot is a prospective open label, single arm, multi-center study conducted in select European countries to evaluate the safety of VisCardia’s novel VisONE implantable system for delivering Asymptomatic Diaphragmatic Stimulation (ADS) as a novel heart failure therapy. “Our objectives are to demonstrate that the promising and consistent evidence of therapeutic efficacy observed to date with the VisONE implantable system can be delivered on a safe and chronic basis. We look forward to sharing our study results over the next upcoming months in peer reviewed scientific conferences,” said VisCardia’s Director of Medical Affairs, Dr. Michael Mirro. The primary measures of the study are safety of the minimally invasive laparoscopic surgical implant procedure and implanted system, with secondary endpoints of heart failure therapeutic efficacy, including acute hemodynamic parameters, cardiac function and heart failure status.

“VisONE provides an innovative and unique approach for improving cardiac performance in medical refractory heart failure patients who currently have no alternative treatment options,” said Dr. Michel Zuber, the principal investigator at the University Hospital in Zurich, Switzerland. “Our expectations are that the chronic improvements to clinically accepted endpoints will mirror those observed during our early proof of concept studies.”

Dr. Tamaz Shaburishvili, from the Heart & Vascular Clinic in Tbilisi, Georgia, one of the study centers, stated that, “While patient enrollment is an accomplishment in any clinical study, we believe the rapid enrollment rate for VisONE can be attributed to the promising evidence to date, the minimally invasive implant procedure, combined with the lack of options for these patients in our center.”

About VisONE® ADS Therapy

The VisONE implantable system delivers VisCardia’s proprietary Asymptomatic Diaphragmatic Stimulation (ADS) therapy for improving cardiac function. By electrically stimulating the diaphragm in an asymptomatic manner, transient intrathoracic pressures gaited to cardiac activity are applied against the cardiac walls, improving both cardiac filling and output. The therapy is non-invasively adjusted and programmed using an external programmer to improve hemodynamic benefit and eliminate undesired stimulatory side effects.

About VisCardia

VisCardia, based in Portland, OR, is developing a novel implantable device therapy for treating heart failure, a condition that afflicts 10 million patients in the U.S. and Europe. To learn more about VisCardia, visit: http://www.viscardia.com.

* The study is conducted by Clinical Accelerator

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Clinical Accelerator announces collaboration with Archivel Farma in a phase IIa Clinical Trial for RUTI®: a therapeutic vaccination against Multi-Drug Resistant Tuberculosis

Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Archivel Farma, for conducting a phase IIa clinical trial for their therapeutic vaccine RUTI® against multi-drug Resistant tuberculosis. The double-blind, randomized and placebo-controlled trial will take place at several specialist tuberculosis sites in the Ukraine alongside with Groningen University Medical Centre in the Netherlands, and will be testing the vaccine’s safety and immunogenicity.

The RUTI® vaccine stimulates host immune effectors directed at bacilli that persist under antibiotic therapy of tuberculosis. It works in tangent with standard antibiotic treatment, improving the efficacy of the standard antibiotic treatment and reducing the chance of recurrence. Clinical safety and immunogenicity has already been proven in healthy volunteers and in individuals with latent tuberculosis infection, both HIV +/ in phase I and II studies. The purpose of the current study is to show that it is safe in patients with multidrug-resistant (MDR-) TB at two different time points of vaccination.

With this study, Archivel Farma aims to evaluate the safety and immunogenicity and to explore the efficacy as the reduction of bacillary load in the sputum of the novel anti-TB vaccine RUTI®, and collect data that could potentially assist in pin-pointing the optimal time to administer RUTI®.

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. 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.

About Archivel Farma

Archivel Farma is an R&D biotech company that develops immunotherapeutic agents to tackle unmet medical needs. The company was founded in 2005 and has ever since been committed to fighting tuberculosis which affects 10 million people every year.

The Director of Clinical Accelerator, Nik Nikitin MD, PhD says, there are significant unmet medical needs in the management of multi-drug resistant tuberculosis (MDR-TB). A large proportion of MDR-TB cases occur in Central and Eastern Europe where Clinical Accelerator runs its clinical studies. The novel anti-TB vaccine RUTI, which is being developed by Archivel Farma can make an important contribution to the fight against MDR-TB in our region of operation and globally. On behalf of Clinical Accelerator, we will be making every effort to make sure that the study is implemented within compact timelines and with high quality.

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The World’s First VisONE® Implantation: a promising start

Below, we are re-publishing with permission the press-release issued by the Heart Institute on the 28th of September 2018

“Thanks to the efforts of the study team from the Heart Institute, we have conducted the first worldwide implantation of the VisONE system that we have developed, and we are going to demonstrate the benefits of the asymptomatic diaphragmatic stimulation (ADS) in heart failure patients and reduced ejection fraction”, – Peter Bauer, President and CEO of VisCardia Inc. in his report at the XIX Ukrainian National Congress of Cardiology (26-28th of September 2018, Kyiv).

On July 25, 2018, the first world-wide implantation of VisONE®, a medical developer VisCardia Inc., was carried out at the Kyiv Institute of Heart in clinical conditions. Thus, the start of an important Pilot Study on the VisONE Heart Failure Study in Ukraine was launched on the use of devices for the treatment of patients with heart failure.

Director General of the Heart Institute – Borys Todurov (left) and President and CEO of VisCardia Inc. – Peter Bauer.

The implantation was held under the control of the Director of Heart Institute, Associate Member of the National Academy of Medical Sciences (NAMN) of Ukraine, Professor Borys Todurov and the Study Principal Investigator Vitaliy Demyanchuk, MD, PhD.

In the 53-year-old patient with a left ventricular ejection fraction lowered to 17%, symptomatic heart failure was observed, despite the optimally chosen regimen of drug therapy. The lack of proper treatment outcome on the one hand and alternative therapies on the other, dictated the use of the VisONE® system.

Surgeon Oleksandr Plegutsa, MD, PhD who performed laparoscopic implantation, emphasized: “The practicality and feasibility of this new and minimally invasive approach reduces the time of the procedure, which is especially important for patients with heart failure. This allows them to recover more quickly than previously applied medical practices.” The implanted system is equipped with an electrical pulse generator, which provides asymptomatic diaphragm stimulation (ADS) to improve the function of the heart. The preclinical studies have shown that ADS improves acute hemodynamic parameters and left ventricular ejection fraction, remaining asymptomatic and devoid of side effects by the technique.

VisONE Heart Failure Study (NCT03484780) team (from left to right):
Igor Kuzmich, Oksana Pantazi, Evgeniy Zhytynskiy, Oleksandr Plegutsa, Piter Bauer, Vitaliy Demyanchuk, Nataliia Ponich, Mukhola Goncharenko, Oksana Davydchuk.

“We are very pleased that this innovative therapy approach will help patients who were previously almost doomed. Our Institute will actively and scrupulously study the effect of this method on heart failure”, – Professor Todurov, Director of the Heart Institute.

http://www.heart.kiev.ua/pershij-v-sviti-implantat-sistemi-visone-bagatoobitsyayuchij-pochatok/

 * The study is conducted by Clinical Accelerator

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Temple Therapeutics BV Announces Publication of Key Mechanism Data for Evitar™

Below, we are re-publishing with permission the press-release issued by Temple Therapeutics BV on the 10th of September 2018

Supports Evitar’s™ Novel Approach for Preventing Acute Tissue Fibrosis (Surgical Adhesions)

Geleen, The Netherlands Temple Therapeutics BV (the “Company” or “Temple”)- September 10, 2018 – Temple, a clinical stage biopharmaceutical company focused in developing therapeutics for fibrosis and oncology, announces the publication of groundbreaking mechanistic data for Evitar™ in Reproductive Sciences, a peer reviewed journal of the Society of Reproductive Investigations. The publication includes data to support a credible hypothesis for Evitar™’s mechanism of action advanced by Temple’s CSO, Dr. Lynne Robertson. This hypothesis proposes that novel drug candidate Evitar™ modulates key upstream inflammatory mediators, such Hypoxia Inducible Factor 1 Alpha (HIF1-α) and Type 1 Collagen, which, when left unchecked, promote abnormal healing and tissue fibrosis.

Robertson, L., King, N., Diamond, M., & Saed, G., Evitar™(l-Alanyl-l-Glutamine) Regulates Key Signaling Molecules in the Pathogenesis of Postoperative Tissue Fibrosis, Reproductive Sciences, September 5, 2018

Additionally, data from the Evitar™ proof-of-concept randomized clinical trial was recently accepted for presentation at 47th Annual Global Congress of AAGL (American Association of Gynecologic Laparoscopists) scheduled for November 2018.

“Post-surgical adhesions are broadly recognized as the single greatest cause of surgical complications. Moreover, they have evaded effective intervention, until now” comments Sanj Singh, CEO of Temple. “These mechanism-of-action and randomized clinical trial data speak to the underlying biology driving surgical adhesions. We are pleased to note the publication’s acceptance in Reproductive Sciences, a high-impact, peer-reviewed journal. This publication and the forthcoming AAGL presentation further support the Evitar™ value proposition. Adhesion prevention is only the beginning. However, it provides a relevant model to further the study of both fibrosis and cancer pathophysiology. Temple is leveraging these insights to further its pipeline of first-in-class therapeutics for the management of adhesions, endometriosis and ovarian cancer.”

About Temple Therapeutics BV

Temple Therapeutics BV is a privately held Dutch based clinical stage development therapeutic drug company, developing first in class and best in class therapeutics to treat acute/chronic fibrosis and cancer. With novel targets linked by a common underlying biology, Temple’s platform has yielded three promising drug candidates to treat post-operative adhesions, endometriosis and ovarian cancer.

About Reproductive Sciences

Reproductive Sciences (RS) is a peer-reviewed, monthly journal publishing original research and reviews in obstetrics and gynecology making it one of the highest ranked and cited journals. RS is multi-disciplinary and includes research in basic reproductive biology and medicine, maternal-fetal medicine, obstetrics, gynecology, reproductive endocrinology, urogynecology, fertility/infertility, embryology, gynecologic/reproductive oncology, developmental biology, stem cell research, molecular/cellular biology and other related fields.

* The study was conducted by Clinical Accelerator

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Clinical Accelerator announces collaboration with Oncolix for developing Prolanta™, a targeted therapeutic protein for the treatment of ovarian, breast and other cancers

Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Oncolix, for conducting clinical studies for its analogue protein, Prolanta, to treat ovarian cancer. The trials will be conducted in the US as well as sites A and B in the Ukraine.

Ovarian Cancer is one of the leading causes of cancer-related death in women and gynecologic death[1]. 80-90% of patients initially respond to chemotherapy but of those, only 10-30% have long-term survival since the majority relapse. Currently, cytotoxic  drugs (chemotherapy) are the only forms of therapy that are available, but as shown, they are not particularly efficacious. Clearly there is a great need for new forms of treatment.

Prolanta is a prolactin receptor antagonist with a single amino acid mutation. This mutation would allow Prolanta to interfere with the binding of two normal prolactin receptors, which would usually cause cancer cell proliferation and also resistance to chemotherapy. It does so through its ability to bind to one prolactin receptor but not the other, blocking prolactin from initiating growth pathways such as the Jak2/STAT pathway. There is significant evidence that this mutated form of prolactin also induces autophagy in ovarian cancer cells.

The purpose of this Phase I study is to evaluate the safety, tolerability and pharmacokinetic parameters of Prolanta monotherapy in patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.[2]  Three dosing levels will also be examined to establish the recommended Phase II dose.

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. 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.

About Oncolix

Oncolix is a Houston, Texas-based, clinical-stage bio-pharmaceutical company dedicated to the development of Prolanta for the treatment of breast, ovarian and other cancers. Oncolix has received approval by the FDA to designate Prolanta as an Orphan Drug for ovarian cancer due to the unmet medical needs.

[1] https://oncolixbio.com/our-science/ovarian-cancer-and-prolanta/

[2] https://www.clinicaltrials.gov/ct2/show/NCT02534922?term=oncolix&rank=1

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