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Angion and Vifor Pharma Announce Completion of Enrollment in Phase 2 Study of ANG-3777 for Cardiac-Surgery Associated Acute Kidney Injury

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UNIONDALE, N.Y. and ST. GALLEN, Switzerland, April 29, 2021 (GLOBE NEWSWIRE) — Angion Biomedica Corp (NASDAQ:ANGN) and Vifor Pharma today announced completion of enrollment for Angion’s AKI-002-15 study, a Phase 2 trial of ANG-3777 in patients at risk of cardiac-surgery associated acute kidney injury (CSA-AKI). This indication is part of the ANG-3777 license agreement both parties signed in November 2020.

“CSA-AKI is a frequent complication of cardiac bypass surgery seen in about one third of patients and is associated with prolonged hospitalization, progressive kidney failure, and an increased risk of death,” commented Dr. John Neylan, Angion’s Senior Vice President and Chief Medical Officer. “Currently, there are no approved therapies to prevent this serious condition. This Phase 2 prevention trial was designed to generate data on ANG-3777 in CSA-AKI patients to help guide future development of ANG-3777 in a Phase 3 registration trial for CSA-AKI. We are planning to start the confirmatory trial early in 2022, subject to the results of this Phase 2 trial as well as discussions with the FDA and other relevant health authorities.”

Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented: “We are excited that enrollment in the AKI-002-15 Phase 2 trial has completed. This is an important milestone in a comprehensive clinical program to advance ANG-3777 as a potential treatment option to prevent acute kidney injury following cardiac surgery, an indication with a high unmet medical need. Together with our partner Angion, we now look forward to assessing the results from the trial.”

The fully enrolled Phase 2 trial is a randomized, multi-center, double-blind, placebo-controlled clinical trial with trial sites in the United States, Canada, Brazil, and Georgia. Patients at risk for CSA-AKI were randomized one-to-one to receive four intravenous doses of 2.0 mg/kg of ANG-3777 or placebo over four days. The first dose was given within four hours of the completion of surgery with subsequent doses given at 24-hour intervals. The primary endpoint is mean area under the curve of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through day six. An additional important endpoint is the occurrence of Major Adverse Kidney Events at 90 days (MAKE 90), which has previously been agreed by the FDA as a suitable primary endpoint for a registration trial in this indication. A MAKE 90 “event” is death, initiation of renal replacement therapy or a greater than 25% decline in eGFR present 90 days after the surgery. The AKI-002-15 Phase 2 trial was designed as a signal-finding trial with the strategic objective to obtain sufficient evidence of efficacy of ANG-3777 to appropriately power and evaluate potential enrichment strategies for a Phase 3 registration trial.

About ANG-3777
ANG-3777 is an investigational small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue and organ repair. ANG-3777 has demonstrated a substantially longer half-life than HGF and Angion believes ANG-3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. Enrollment is complete in a Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, a Phase 2 exploratory trial in cardiac-surgery associated acute kidney injury, and a Phase 2 exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights excluding Greater China to commercialize ANG-3777 in renal indications with up to $1.925 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40%. Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China in 2018.

About Angion
Angion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic currently being evaluating in a Phase 3 registration trial for delayed graft function in patients undergoing deceased donor kidney transplantation, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit www.angion.com.

About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceutical company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com.

Forward Looking Statements
Statements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations regarding the potential safety and efficacy of ANG-3777, the potential results and outcomes of the AKI-002-15 study, and other studies involving ANG-3777 or other product candidates, the timing of the commencement of future clinical trials and the timing of availability of and Angion’s disclosure of topline data from such studies. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: Angion’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ANG-3777 and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; the effects of COVID-19 on the Company’s clinical programs and business operations. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 30, 2021, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law. 


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Dymax Introduces 9906-AA Low-Shrinkage Cationic Epoxy for the Asia Active Alignment Market

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SINGAPORE, May 11, 2021 /PRNewswire/ — Dymax, leading manufacturer of rapid light-curing materials and equipment, has developed a light and/or heat-curable cationic epoxy for active alignment of camera modules, optical components, LiDAR (Light Detection and Ranging), and other ADAS (Advanced Driver Assistance Systems) assemblies used in automotive applications.

Diagram of Optical Path Optimization in Active Alignment

Optical components, lenses in cameras, CCD chips or complex optical devices need to be positioned economically and efficiently. Active alignment is the primary solution for making high-precision image systems manufacturable and feasible in final products, where devices need to align down to micron accuracy. 9906-AA has very low volumetric shrinkage, high Tg, and low coefficient thermal expansion (CTE), and was developed to meet these rigorous active alignment requirements.

The flexibility to cure very fast with broad spectrum UV light, LED light, or low temperature heat accommodates a variety of application needs. As our next generation cationic epoxy, 9906-AA and has improved 85°C/85% RH resistance, exhibits less overall movement through thermal excursions, and features higher viscosity and thixotropy to maintain bead shape upon dispense. In addition, the material can be refrigerated and shipped/stored at 1-5°C, and not frozen. Dymax 9906-AA meets NASA ASTM E595 low-outgassing specifications making this solution ideal for critical optical components. All these characteristics help manufacturers improve time-to-market, reduce scrap costs, and enhance overall image quality.

Typical camera module applications include bonding the lens barrel to holder, lens bonding, and bonding the holder to printed circuit boards (PCBs).

About Dymax

Dymax develops innovative rapid and light-curable materials, dispense equipment, and UV/LED light-curing systems. The company’s adhesives, coatings, and equipment are perfectly matched to work seamlessly with each other, providing design engineers with tools to dramatically improve manufacturing efficiencies. Major markets include aerospace and defense; medical device; and consumer and automotive electronics.

For additional information on Dymax, visit www.dymax.com 

SOURCE Dymax

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TuSimple Reports Receiving 6,775 Orders For Its Self-Driving Electric Truck

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Self-driving trucking company TuSimple Holdings (NASDAQ:TSP) said on Monday it scored 1,000 new bookings in April and added 1,200 in the first quarter, taking its total booking to 6,775 trucks so far.

What Happened: The San Diego-based autonomous trucking company that raised $1.35 billion in a public offering last month is gearing up to launch driverless 18-wheelers in partnership with Navistar International Corp (NYSE:NAV) beginning 2024.

The company said trucking companies Penske Truck Leasing, Schneider National Inc (NYSE:SNDR) and US Xpress Enterprises Inc (NYSE:USX) are among the large freight transportation companies in North America to place the orders. 

TuSimple and Navistar had last year announced a strategic partnership to co-develop L4 autonomous heavy-duty trucks. 

About 53% of its total bookings now are from truck carriers, 30% from rail operators and 17% are from shippers and parcel carriers, the company CEO Cheng Lu said.

Reservations are non-binding and require a $500 truck deposit.

Why It Matters: The development comes at a time as competition in self-driving technology picks up pace. On Monday, Plus announced a SPAC deal with plans to launch autonomous trucks in 2021.

Plus is working on mass production-ready, low-cost Level 4 autonomous driving technology for the long-haul trucking sector. 

See Also: Autonomous Trucking Company Plus Announces SPAC Deal: What Investors Should Know

In the trucking industry, there is a driver shortage, high driver turnover and about two-thirds of costs are made up from labor and fuel.

Price Action: TuSimple shares closed 0.54% lower at $37.09 on Monday.

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Bella Aurora launches its first treatment for white patches on the skin

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– Almost 2% of worldwide population have white patches on the skin caused by lack of pigmentation1

– World Vitiligo Day is observed on 25th June

MADRID, May 11, 2021 /PRNewswire/ — Bella Aurora Labs, a pioneering company that for more than 130 years has specialised in the study of melanocytes, has announced the launch of Repigment, its first ever line formulated to treat white patches on the skin. Repigment is the culmination of a more than four-year collaboration with Italian dermatologist and vitiligo specialist Dr Matteo Bordignon.

DrMatteo y Jordi Segura: Jordi Segura, R&D Director at Bella Aurora Labs and Dr Matteo Bordignon.

“As experts in the study of melanocytes and skin pigmentation, we can offer a solution to skins with abnormal pigmentation. Approximately two per cent of the global population has this skin condition which, although it is not painful, has a psychological impact.” says Jordi Segura, R&D Director at Bella Aurora.

“In the course of my work as a dermatologist, I treat numerous people with hypo- pigmentation, most of whom are desperate to find an effective treatment. With Repigment, we now have an opportunity to improve these people’s lives, making my ten years of research even more significant.” says Dr Matteo Bordignon.

It was in 2013 that Dr Bordignon published2 his discovery that the MIA protein, produced abnormally by melanocytes, is responsible for hypopigmentation or the formation of white patches on the skin. His studies demonstrate how the MIA protein breaks the adhesion system of melanocytes to the basal membrane, from which they become detached and are lost. It is the absence of melanocytes that causes the appearance of white patches.

REPIGMENT
The new treatment for hypopigmentation

Repigment is Bella Aurora’s first ever effective treatment for white patches. As well as stopping new white patches from developing, this patented product also restores the pigment to the affected areas.

The new Repigment line consists of the repigmenting cream that contains the Repigma12 peptide to block the MIA protein, and RepigmentSun capsules, a food supplement that prepares the skin for exposure to the sun or for booth radiation sessions.

Recommendations: apply the cream twice daily to the affected areas and take one capsule with a glass of water with a meal to protect the skin. The treatment must be accompanied by exposure to natural sunlight or artificial UV light under the supervision of a health professional. It is recommended to follow the treatment for at least six months or until the area is fully repigmented.

Repigment is available on www.bella-aurora.com. 

PROVEN RESULTS
Results of 150 days of treatment and phototherapy3.
It is necessary to continue with the treatment until the complete repigmentation.  

#Repigment #WhitePatchesTreatment

About Bella Aurora

Bella Aurora, as part of Bella Aurora Labs, has a history that dates back 130 years. As a result of its experience in the study of melanocytes, Bella Aurora has developed an efficient solution that eliminates dark spots from the skin.

Bella Aurora has invested in decades of research into the different mechanisms that influence skin pigmentation processes. The company’s scientific expertise in this area has resulted in the launch of patented B-CORE 221TM on the market, an exclusive technology that will represent a turning point in the treatment of abnormal pigmentation.

It already has a solid presence in Europe, Asia and the US and is on a mission to become an established world leader in skin pigmentation and the number one for eliminating dark spots and white patches.

About Dr Matteo Bordignon

Dr Matteo Bordignon qualified in Medicine and Surgery with the highest scores and honours from the University of Padua. In 2009, he specialised with honours in Dermatology and Venereology at the University of Padua, one of the most prestigious in Italy and one of the oldest in the world. He is also the author and co-author of numerous articles in international scientific journals and during his training he took part in clinical trials and laboratory activities. In the research field, after years studying vitiligo, Dr Bordignon was the first to identify the relationship between the MIA protein and this skin condition.

To request an interview with Dr Matteo Bordignon, please contact Alejandra Delgado.

1. Source: European Academy of Dermatology and Venereology.

2. Bordignon M, Castellani C, Fedrigo M, Thiene G, Peserico A, Alaibac M, et al. Role of alpha5beta1 integrin and MIA (melanoma inhibitory activity) in the pathogenesis of vitiligo. J Dermatol Sci. 2013 Aug;71(2):142-5.

3. Source: Bordignon M. Development of a new topical treatment for vitiligo based on the MIA-inhibitors technology. 2020; Jan. Data on File.

Photo – https://zephyrnet.com/wp-content/uploads/2021/05/bella-aurora-launches-its-first-treatment-for-white-patches-on-the-skin.jpg
Photo – https://zephyrnet.com/wp-content/uploads/2021/05/bella-aurora-launches-its-first-treatment-for-white-patches-on-the-skin-1.jpg
Logo – https://zephyrnet.com/wp-content/uploads/2021/05/bella-aurora-launches-its-first-treatment-for-white-patches-on-the-skin-2.jpg

Repigment12 Crema Bella Aurora: Repigment12, the first ever line formulated to treat white patches on the skin

Bella Aurora Logo

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Clarity Gold Acquires Strategic Surface Rights Over the Destiny Project in the Abitibi Region

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VANCOUVER, British Columbia, May 11, 2021 (GLOBE NEWSWIRE) — Clarity Gold Corp. (“Clarity” or the “Company”) (CSE: CLAR, OTC: CLGCF, FSE: 27G) is pleased to announce the purchase of surface rights of two lots for a resulting total area of approximately 82 hectares over a key portion of the Destiny Project in the Abitibi Greenstone Belt in Quebec.

The surface rights cover the core of the historic work and were purchased from a local family in the region. Securing these surface rights will allow the company to work efficiently and provide security to advance the project.

“After much due diligence, we are thrilled to acquire these surface rights. It will allow the company to cost effectively carry out its work as our drilling program progresses. It is a move forward for the security of advancing this Project as a long-term investment,” said James Rogers, CEO of Clarity. “In addition to providing easier access to the work area these surface rights secure a space for project infrastructure as we advance.”

The total purchase of $250,000.00 for two lots, at $125,000.00 per lot involves a cash payment of $25,000.00 per lot at closing, with the remaining balance of $100,000.00 per lot payable in 4 equal consecutive installments of $25,000.00 every quarter following the closing. The previously mentioned total area is net of an approximately 1.86 hectare portion of one of the lots that will be subdivided and transferred to the vendors. Clarity will have a right of access servitude through this subdivision.

About the Destiny Project

Clarity Gold Corp. is actively drilling and advancing the 5,013 ha Destiny Project is located in the prolific Abitibi Greenstone Belt along a major structural break which is largely underexplored. The project has excellent infrastructure, with road access approximately 75 km NNE of the city of Val d’Or and has considerable work done to date including over 50,000 m of diamond drilling.

For a more detailed account, the reader is encouraged to refer to the Company’s website.

About Clarity

Clarity Gold Corp. is a Canadian mineral exploration company focused on the acquisition, exploration and development of gold projects in Canada. The Company has entered into an option agreement to purchase 100% of the Destiny Project, Clarity’s flagship asset, a gold-focused project in the mineral rich Abitibi region in Quebec. The Company is based in Vancouver, British Columbia, and is listed on the CSE under the symbol “CLAR”. To learn more about Clarity Gold Corp. and its projects please visit www.claritygoldcorp.com.

ON BEHALF OF THE BOARD
James Rogers
Chief Executive Officer
Tel: 1 (833) 387-7436
Email: info@claritygoldcorp.com
Website: claritygoldcorp.com

The Canadian Securities Exchange (operated by CNSX Markets Inc.) has neither approved nor disapproved of the contents of this press release.

 


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