Market Newsdesk

RADNOR, Pa. and GENEVA, Nov. 24, 2020 /PRNewswire/ — NeuroRx, Inc., and Relief  AG (SIX: RLF, OTCQB: RLFTF), announce that more than 175 patients with Critical COVID-19 and Respiratory Failure who also have a severe comorbidity have now been entered into an Expanded Access Protocol (EAP) with RLF-100^TM in the United States.

All patients had severe comorbidities (such as organ transplant, recent heart attack, and cancer) that rendered them ineligible for the ongoing randomized, controlled phase 2b/3 trial being conducted to ascertain safety and efficacy of RLF-100™, and all patients were deteriorating despite treatment with approved therapies for COVID-19 (see www.clinicaltrials.gov NCT 04311697).  Of the 90 patients who have so far reached 28 days of follow-up, 72% survived to day 28.   

As previously reported by Youssef and coworkers (http://dx.doi.org/10.2139/ssrn.3665228), at Houston Methodist Hospital, 21 patients treated with RLF-100™ under the EAP were compared to 24 control patients treated in the same setting.   Only 17% of the control patients, all treated with best available intensive care unit (ICU) Standard of Care, survived to day 28.  The survival rate with RLF-100^TM reported today is comparable to that seen among the open-label patients treated with RLF-100™ by Youssef et al.  Despite advancements in treating COVID-19, survival for the patients at highest risk due to severe comorbidities has remained dismal in the absence of an effective therapy.

Notably, in the EAP, no drug-related Serious Adverse Events have been reported to date among these patients nor the 160 patients randomized to RLF-100™ vs. placebo in the U.S. phase 2b/3 clinical trial currently underway.  Thus, from a risk/benefit perspective, while the benefit of RLF-100^TM has not yet been proven in a randomized prospective trial, no serious risk has been identified so far.

Currently, 25 U.S. hospitals have enrolled patients in the EAP, nearly all of which are community hospitals, suggesting that RLF-100™ can demonstrate effectiveness in the hands of front-line physicians who deliver the majority of care to patients with Critical COVID-19. Physicians enrolling patients in the EAP have routinely reported that initial patients at their sites have frequently been in the ICU for several weeks without recovery prior to treatment with RLF-100^TM.  As patients are treated earlier in the course of their ICU stay, there is an emerging clinical impression that RLF-100^TM has an even greater impact on recovery.

“We are reassured that emerging real-world data on the use of RLF-100^TM in improving survival in patients with Critical COVID-19 are comparable to results seen in the hands of major academic teaching centers. We hope that these findings are viewed as encouraging at a time when many Americans, including the doctors, nurses, and other front-line caregivers who are the heart of our initiative, are celebrating the Thanksgiving holiday at a distance from their loved ones.  We look forward to completing enrollment and reporting the results of our pivotal U.S. clinical trial,” said Prof. Jonathan C. Javitt, MD, MPH, CEO and founder of NeuroRx, Inc. 

ABOUT VIP IN LUNG INJURY
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, that is critical to transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.

COVID-19-related death is primarily caused by respiratory failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.

Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and are essential for oxygen exchange. Other than RLF-100™, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.

ABOUT RLF-100™
RLF-100™ (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami Said’s original work for which FDA awarded an Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100™ for the treatment of COVID-19 and awarded Fast Track designation. RLF-100™ is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, more than 150 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100™ under FDA-approved protocols. Information on the RLF-100™ Expanded Access program is at https://www.neurorxpharma.com/our-services/rlf-100.

ABOUT RELIEF THERAPEUTICS HOLDING AG
Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Relief holds orphan drug designations from the U.S. FDA and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a patent issued in the U.S. and multiple other countries covering potential formulations of RLF-100™.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on the OTCQB under the symbol RLFTF.

ABOUT NEURORX INC.
NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100™, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer’s Neuroscience and Pain Division. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for RLF-100™ for the treatment of COVID-19. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

View original content to download multimedia:http://www.prnewswire.com/news-releases/neurorx-and-relief-announce-initial-successful-results-from-expanded-access-use-of-rlf-100-aviptadil-in-patients-with-critical-covid-19-and-severe-comorbidity-72-survival-seen-in-icu-patients-301179820.html

SOURCE NeuroRx

NEW YORK, Nov. 24, 2020 /PRNewswire/ — S&P Dow Jones Indices today released the latest results for the S&P CoreLogic Case-Shiller Indices, the leading measure of U.S. home prices. Data released today for September 2020 show that home prices continue to increase across the U.S. More than 27 years of history are available for these data series, and can be accessed in full by going to https://www.spglobal.com/spdji/.

Please note that transaction records for August 2020 for Wayne County, MI are now available. Due to delays at the local recording office caused by the COVID-19 lockdown, S&P Dow Jones Indices and CoreLogic were previously unable to generate a valid August 2020 update of the Detroit S&P CoreLogic Case-Shiller indices.

However, there are not a sufficient number of records for the month of September for Detroit. Since Wayne is the most populous county in the Detroit metro area, S&P Dow Jones Indices and CoreLogic are unable to generate a valid Detroit index value for the November release. When the sale transactions data fully resumes and sufficient data is collected, the Detroit index values for the month(s) with missing updates will be calculated.

YEAR-OVER-YEAR 
The S&P CoreLogic Case-Shiller U.S. National Home Price NSA Index, covering all nine U.S. census divisions, reported a 7.0% annual gain in September, up from 5.8% in the previous month. The 10-City Composite annual increase came in at 6.2%, up from 4.9% in the previous month. The 20-City Composite posted a 6.6% year-over-year gain, up from 5.3% in the previous month.

Phoenix, Seattle and San Diego continued to report the highest year-over-year gains among the 19 cities (excluding Detroit) in September. Phoenix led the way with an 11.4% year-over-year price increase, followed by Seattle with a 10.1% increase and San Diego with a 9.5% increase. All 19 cities reported higher price increases in the year ending September 2020 versus the year ending August 2020. 

MONTH-OVER-MONTH
The National Index posted a 1.2% month-over-month increase, while the 10-City and 20-City Composites both posted increases of 1.3% and 1.2% respectively, before seasonal adjustment in September. After seasonal adjustment, the National Index posted a month-over-month increase of 1.4%, while the 10-City and 20-City Composites both posted increases of 1.2% and 1.3% respectively. In September, all 19 cities (excluding Detroit) reported increases before seasonal adjustment, and after seasonal adjustment.

ANALYSIS
“Housing prices were notably – I am tempted to say ‘very’ – strong in September,” says Craig J. Lazzara, Managing Director and Global Head of Index Investment Strategy at S&P Dow Jones Indices. “The National Composite Index gained 7.0% relative to its level a year ago, well ahead of August’s 5.8% increase. The 10- and 20-City Composites (up 6.2% and 6.6%, respectively) also rose at an accelerating pace in September. The strength of the housing market was consistent nationally – all 19 cities for which we have September data rose, and all 19 gained more in the 12 months ended in September than they had done in the 12 months ended in August.

“A trend of accelerating increases in the National Composite Index began in August 2019 but was interrupted in May and June, as COVID-related restrictions produced modestly-decelerating price gains. Our three monthly readings since June of this year have all shown accelerating growth in home prices, and September’s results are quite strong. The last time that the National Composite matched September’s 7.0% growth rate was more than six years ago, in May 2014. This month’s increase may reflect a catch-up of COVID-depressed demand from earlier this year; it might also presage future strength, as COVID encourages potential buyers to move from urban apartments to suburban homes. The next several months’ reports should help to shed light on this question.

“Phoenix’s 11.4% increase topped the league table for September; this is the 16^th consecutive month in which Phoenix home prices rose more than those of any other city. Seattle (10.1%) and San Diego (9.5%) repeated in second and third place. Even the worst-performing cities, New York (4.3%) and Chicago (4.7%), did better in September than in August. Prices were strongest in the West and Southwest regions, but even the comparatively weak Midwest scored 6.0% gains.”

SUPPORTING DATA 
Table 1 below shows the housing boom/bust peaks and troughs for the three composites along with the current levels and percentage changes from the peaks and troughs.

Table 2 below summarizes the results for September 2020. The S&P CoreLogic Case-Shiller Indices are revised for the prior 24 months, based on the receipt of additional source data.

Table 3 below shows a summary of the monthly changes using the seasonally adjusted (SA) and non-seasonally adjusted (NSA) data. Since its launch in early 2006, the S&P CoreLogic Case-Shiller Indices have published, and the markets have followed and reported on, the non-seasonally adjusted data set used in the headline indices. For analytical purposes, S&P Dow Jones Indices publishes a seasonally adjusted data set covered in the headline indices, as well as for the 17 of 20 markets with tiered price indices and the five condo markets that are tracked.

For more information about S&P Dow Jones Indices, please visit https://www.spglobal.com/spdji/.

ABOUT S&P DOW JONES INDICES
S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500^® and the Dow Jones Industrial Average^®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has been innovating and developing indices across the spectrum of asset classes helping to define the way investors measure and trade the markets.

S&P Dow Jones Indices is a division of S&P Global (NYSE: SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit https://www.spglobal.com/spdji/.

FOR MORE INFORMATION:

April Kabahar
Global Head of Communications
New York, USA
(+1) 212 438 7530
[email protected]

Raymond McConville

Communications Manager
New York, USA
(+1) 212 438 1678
[email protected]

S&P Dow Jones Indices’ interactive blog, IndexologyBlog.com, delivers real-time commentary and analysis from industry experts across S&P Global on a wide-range of topics impacting residential home prices, homebuilding and mortgage financing in the United States. Readers and viewers can visit the blog at www.indexologyblog.com, where feedback and commentary are welcomed and encouraged.

The S&P CoreLogic Case-Shiller Indices are published on the last Tuesday of each month at 9:00 am ET. They are constructed to accurately track the price path of typical single-family homes located in each metropolitan area provided. Each index combines matched price pairs for thousands of individual houses from the available universe of arms-length sales data. The S&P CoreLogic Case-Shiller U.S. National Home Price Index tracks the value of single-family housing within the United States. The index is a composite of single-family home price indices for the nine U.S. Census divisions and is calculated quarterly. The S&P CoreLogic Case-Shiller 10-City Composite Home Price Index is a value-weighted average of the 10 original metro area indices. The S&P CoreLogic Case-Shiller 20-City Composite Home Price Index is a value-weighted average of the 20 metro area indices. The indices have a base value of 100 in January 2000; thus, for example, a current index value of 150 translates to a 50% appreciation rate since January 2000 for a typical home located within the subject market.

These indices are generated and published under agreements between S&P Dow Jones Indices and CoreLogic, Inc.

The S&P CoreLogic Case-Shiller Indices are produced by CoreLogic, Inc. In addition to the S&P CoreLogic Case-Shiller Indices, CoreLogic also offers home price index sets covering thousands of zip codes, counties, metro areas, and state markets. The indices, published by S&P Dow Jones Indices, represent just a small subset of the broader data available through CoreLogic.

Case-Shiller^® and CoreLogic^® are trademarks of CoreLogic Case-Shiller, LLC or its affiliates or subsidiaries (“CoreLogic”) and have been licensed for use by S&P Dow Jones Indices. None of the financial products based on indices produced by CoreLogic or its predecessors in interest are sponsored, sold, or promoted by CoreLogic, and neither CoreLogic nor any of its affiliates, subsidiaries, or predecessors in interest makes any representation regarding the advisability of investing in such products.

View original content:http://www.prnewswire.com/news-releases/sp-corelogic-case-shiller-index-shows-annual-home-price-gains-soared-to-7-in-september-301179819.html

SOURCE S&P Dow Jones Indices

AKRON, Ohio, Nov. 24, 2020 /PRNewswire/ — Goodyear and the U.S. Marine Corps Reserve are partnering for the tenth consecutive year in support of the Marine Toys for Tots Foundation at the company’s airship bases in Florida and Ohio. The Goodyear Blimp events will provide the public with an opportunity to donate to Toys for Tots while enjoying an up close and personal view of the blimp inside the hangar.

Beginning Dec. 1 and continuing through Dec. 11, toy donations will be accepted at select Goodyear Auto Service Center locations in Florida and Ohio. Additionally, Dec. 3 through Dec. 13, Goodyear Toys for Tots drop-off locations are expanding to Roll by Goodyear locations in D.C. Metro and Greater Philadelphia, offering donors $10 back on a tire alignment when a toy is donated in-store.* Additional details on store locations is available below and on www.goodyearblimp.com.  

Donors are required to follow Goodyear’s COVID-19 protocols, including wearing a mask while on property, social distancing guidelines and having toys in the trunk of your vehicle. Goodyear will be hosting drive-thru donation events at the Ohio and Florida bases. On Dec. 11, 12 and 13, from 2 p.m. to 8 p.m., Ohio visitors can drive through the Wingfoot Lake blimp hangar to drop off their donation to a U.S. Marine representing Toys for Tots. The Florida drive-thru event will take place on Dec. 12 from 3 p.m. to 6 p.m. These events are free and open to the public, with all attendees required to follow locally mandated guidelines and precautions to prevent the spread of COVID-19. Toys can also be shipped to Goodyear’s hangars through Dec. 8 for contactless donation. Toys being donated must be new and in the original packaging to be accepted.

“So much has changed this year in our communities and it’s critical that we continue to find ways to support them through safe and unique experiences like this,” said Laura Duda, Goodyear’s senior vice president and Chief Communications Officer.  “Through our Toys for Tots support over the past decade, we have expanded on our strong relationship with the U.S. Marine Corps, and we are pleased to continue delivering much-needed donations of toys to the children who need them most, especially right now.”

2020 marks the tenth year of the collaboration between Goodyear and the Marines for events at its airship bases in Ohio and Florida, which have collectively delivered almost 150,000 toys and nearly $500,000 to benefit Toys for Tots to date.

“We are very pleased to welcome Goodyear back for their 10th year as a National Corporate Sponsor of the Marine Toys for Tots Campaign,” said retired Marine Colonel Ted Silvester, Vice President of the Marine Toys for Tots Foundation. “Their community service goals certainly align with those the Marine Corps has promoted for over 72 years through our Toys for Tots Program.” Silvester concluded, “With their generous support we will be able to fulfill the Christmas holiday dreams of thousands of less fortunate children who otherwise might be forgotten.”

Goodyear first nicknamed one of its blimps the “Santa Claus Express” in 1927 to spread holiday cheer across the skies of America. The company has a long history of community involvement and volunteerism within its corporate social responsibility program, Goodyear Better Future. Goodyear Better Future initiatives and Goodyear Airship Operations support collaborative programs, such as the Toys for Tots Foundation and community organizations to drive positive outcomes for the community.

Founded in 1948, it is the mission of the U.S. Marine Corps Reserve Toys for Tots Program to collect new, unwrapped toys during October, November and December and distribute these toys as Christmas gifts to less fortunate children in the community in which the campaign is conducted.

The Ohio Goodyear airship base is located at 841 Wingfoot Lake Rd., Mogadore, Ohio 44260.

The Florida Goodyear airship base is located at 1500 NE 5th Ave, Pompano Beach, FL 33060.

Donation details are available online at www.goodyearblimp.com, by visiting the Goodyear Blimp Facebook page or by calling (800) 344-9859.

Goodyear Auto Service Centers and Roll by Goodyear locations participating in the toy collection are:

*Roll by Goodyear $10 Back Offer Details:

Redeem at Roll by Goodyear locations or by phone; void where prohibited by law. Offer applies to most vehicles. Limit one offer per customer per vehicle. No other service discounts apply. Requires toy donation at Roll by Goodyear participating showrooms 12/3/20 –12/13/20 and purchase of an alignment service 12/3/20 – 12/31/20. Guests to receive $10 Visa prepaid gift card at time of service. Additional terms, conditions and fees may apply. See prepaid card for details. Visit showroom or call 800-344-4502 for complete details.

About The Goodyear Tire & Rubber Company

Goodyear is one of the world’s largest tire companies. It employs about 62,000 people and manufactures its products in 46 facilities in 21 countries around the world. Its two Innovation Centers in Akron, Ohio, and Colmar-Berg, Luxembourg, strive to develop state-of-the-art products and services that set the technology and performance standard for the industry. For more information about Goodyear and its products, go to www.goodyear.com/corporate.

View original content to download multimedia:http://www.prnewswire.com/news-releases/goodyear-us-marine-corps-reserve-to-host-10th-annual-toys-for-tots-events-301179811.html

SOURCE The Goodyear Tire & Rubber Company