Brett Favre
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NFL legend Brett Favre attended the University of Southern Mississippi, and after a stellar college career, Favre was selected by the Atlanta Falcons in the 1991 NFL draft. Following his trade to the Green Bay Packers the next year, Favre began his legendary NFL career and led the franchise to victory in Super Bowl XXXI. Favre, an NFL ironman, started 299 consecutive games, a record that still stands today. Among his achievements, he recorded six 4,000 passing yard seasons; was named all NFC 6 times and elected to 11 pro bowl teams. When Favre retired from football after the 2010 season, he held the NFL records for passing attempts, completions, passing yards and touchdown passes. Favre was enshrined into the NFL Hall of Fame in 2016.

Kurt Warner
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Kurt Warner's football career has proven to be of the more improbable rags-to-riches stories ever to come out of the sports world. Bypassed by the big Division I colleges, and at one point working the night shift stocking shelves at a supermarket so he could stay in football shape during the day, Warner, a 28-year-old back-up quarterback, catapulted to stardom in 1999. During his second full year in the NFL, he drove a high-powered St. Louis Rams offense to a Super Bowl victory and collected MVP honors along the way. Over the ensuing decade, Warner captained two other teams to the Super Bowl, registered another MVP season and threw for more than 200 career touchdowns. In 12 NFL seasons, Warner was selected to 4 Pro Bowl teams among his numerous accolades. He was enshrined in the NFL Hall of Fame in 2017.

Steve Mariucci
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Mariucci is a former National Football League head coach. He coached for the San Francisco 49ers and most recently for the Detroit Lions. Mariucci was born and raised in Iron Mountain, Michigan, and was a three-time All-America (Division II) quarterback at Northern Michigan University (NMU) in Marquette. On NFL Sundays, Steve Mariucci appears on NFL Network's Emmy-nominated NFL GameDay Morning, joining fellow analysts to discuss the upcoming games four hours prior to kickoff. Additionally, Mariucci provides on-location analysis for NFL Network's coverage of the Super Bowl, NFL Scouting Combine and NFL Draft. In April 2009, Mariucci was recognized for his work as an NFL Network analyst with his first Sports Emmy nomination in the Outstanding Sports Personality – Studio Analyst category.

Mark Rypien
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Mark Rypien is a former professional football quarterback who has played for some of the best NFL teams as a Washington Redskin. Born in Alberta, Canada, Mark moved to the United States at the age of 3 and was an athletic kid. He was a star athlete in school, playing basketball, baseball, and football. Following his high school graduation, he chose football and enrolled into the Washington State University on a football scholarship. He was selected by the Washington Redskins in the 1986 NFL Draft. In his stellar NFL career, he appeared in 104 games and had 115 touchdowns with 88 interceptions and 18,473 passing yards. Mark Rypien has a multitude of achievements throughout his NFL career. He is a 2 time Super Bowl champion (XXII,XXVI), a Super Bowl MVP (XXVI) in addition to being elected to the Pro Bowl two times.

David Ross
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David Wade Ross (born March 19, 1977) is an American professional baseball manager for the Chicago Cubs and former catcher for numerous teams in Major League Baseball (MLB). He played for 15 years in MLB. Ross played college baseball for Auburn University and the University of Florida and participated in two College World Series. He started his major league career playing for the Los Angeles Dodgers in 2002 and also played for the Pittsburgh Pirates, San Diego Padres, Cincinnati Reds, Boston Red Sox, Atlanta Braves, and Chicago Cubs. Ross had two World Series wins with the Boston Red Sox in 2013 and the Chicago Cubs in 2016. The Cubs named him their manager prior to the 2020 season.

Abby Wambach
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Abby Wambach was born in Rochester, NY and is a decorated American association football (soccer) player who was one of the sport’s leading forwards. She helped the U.S. Women’s National Team (USWNT) win two Olympic gold medals (2004 and 2012) and a World Cup (2015). In 2012 she was named Women’s Player of the Year by the Fédération Internationale de Football Association (FIFA). Wambach made her first appearance for the USWNT in 2001. Wambach started nine times for the USWNT in 2003, including all five U.S. matches in the FIFA Women’s World Cup, where the United States finished third. She was named U.S. Soccer’s Female Athlete of the Year, a feat she achieved again in 2004, 2007, 2010, 2011, and 2013.

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Media for Concussion Drug

Brett Favre speaks about Prevacus and his experience with concussions during and after his Football career:

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Odyssey Group plans to develop a neurosteroid (PRV-001) for various brain maladies (leutodystrophies). Initial focus is on a disease called Nieman Picks Type C, a rare brain disorder in children that is always fatal. This is considered an “orphan indication” by the FDA and therefore has special considerations for the FDA approval process.

Niemann Pick Type-C Disease

  • Niemann-Pick Type C disease (NPC) is an autosomal recessive, lysosomal storage disorder characterized by accumulation of cholesterol and gangliosides in the brain and liver
  • NPC is a rare (estimated US prevalence of 1:150,000) neurodegenerative disorder. Prevalence is 5X higher with Arabian decent
  • Children with NPC demonstrate neurological dysfunction with cerebellar ataxia, dysarthria, seizures, visual palsy, motor impairment, dysphagia, psychotic episodes, and progressive dementia
  • There is no effective treatment for NPC and it is a lethal disorder

PRV-001 MECHANISM

PRV-001 TOXICOLOGY

  • PRV-001 binds to the Pregnane X Receptor (PXR)
    • The PXR is an intracellular receptor found in neurons, glia and the endothelium of the blood brain-barrier
    • Binding of PRV-001 to the PXR activates multiple gene response elements promoting transcription of anti-inflammatories (CD55), anti-oxidants (gluthione s-transferase) and efflux channels (P-Glycoprotein) for toxins and fluid.
    • Further PRV-001 promotes neuronal growth and differentiation
  • PRV-001 is not a GABAergic compound, no fatigue
  • Acute and sub-acute dose ranging studies were executed in rats and dogs – SC, IN, IV routes
    • MTD (IV) = 38 mg/kg
    • Signs of toxicity were limited to vehicle
  • 14-Day GLP toxicology in rats and dogs
    • Rat: MTD = 46 mg/kg
    • Dog: MTD = 46 mg/kg
    • No drug-related effects noted in hematology, blood chemistry, BW, FC, or histopathology (except for slight nasal turbinate irritation)

PRV-001 SUMMARY

PRV-001 – a First-in-Class Neurosteroid for the treatment of Niemann Pick Type-C Disease
  • IP covers methods of preparation and methods of use
  • Few competing products currently in human trials
  • Pre-clinical efficacy underway
  • No drug-related toxicity observed
  • Nasal formulation finalization in progress