$RGBP

New Post Public Reply Private Reply Replies (0) Message Board
//Desmond//
$RGBP NEWS

http://www.prnewswire.com/news-releases/regen...39361.html

Regen BioPharma Submits Application to FDA for Orphan Drug Designation for its HemaXellerate Product

PR Newswire

SAN DIEGO, January 26, 2016


SAN DIEGO, January 26, 2016 /PRNewswire/ --

Regen BioPharma, Inc., (OTCBB: RGBP) and (PINK: RGBP) announced today submission to the Food and Drug Administration (FDA) of an application requesting Orphan Drug status for the use of HemaXellerate for the treatment of aplastic anemia.

"Because HemaXellerate is a personalized cell therapy product aimed at addressing an unmet medical need, we are hopeful that the FDA will grant it orphan status," said David Koos, Ph.D., Chairman and CEO of Regen BioPharma.

HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method so as to induce a biological response in the patient that heals damaged bone marrow and restores ability of the body to generate healthy blood cells. The FDA recently cleared Regen to perform phase I clinical trials using HemaXellerate in aplastic anemia patients.

Having an Orphan Drug designation for HemaXellerate is important as it will allow for:
•Annual grant funding to defray the cost of clinical testing
•Tax credits for the costs of clinical research
•Assistance in clinical research study design
•Seven-year period of exclusive marketing after an orphan drug is approved
•Waiver of Prescription Drug User Fee Act (PDUFA) filing fees

"Should HemaXellerate be fortunate enough to be designated an Orphan Drug, we will take advantage of the rich resources the National Institutes of Health provides in assisting development of such drugs to get HemaXellerate to market as quickly as possible," said Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen BioPharma.

About Regen BioPharma, Inc.

Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.

Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

Contact:
Regen BioPharma Inc.

David R. Koos, PhD
Chairman & Chief Executive Officer
+1-619-702-1404 Phone
+1-619-330-2328 Fax
David.koos@regenbiopharma.com

The Dorsee Company
Debra Dorsee
+1-858-229-6082
Debbie@thedorseecompany.com

http://www.regenbiopharma.com
http://www.regenbiopharmainc.com
david.koos@regenbiopharma.com

Twitter: Regen BioPharma News: https://twitter.com/KoosRegen


SOURCE Regen BioPharma Inc.

Trade and Invest for Your Retirement All in One Place with E*TRADE.

Read More: http://investorshangout.com/post/view?id=3505...z3yMK3AQzF
All of my posts are honest, opinion based statements from due diligence performed by myself.
Scroll down for more posts ▼

Top 10 Most Recent News Articles

See's Candies Data Breach Spurs Legal Scrutiny

Updated Category News Views 10

Data Breach Hits See's Candies Hard Amidst Ransomware Attack Alright, folks, here's a not-so-sweet tale to kick off your day — See's Candies has found itself in a bit of a pickle. A ransomware attack, the nasty kind that makes you double-check your locks and your passwords, has reportedly exposed the personal data of its customers and employees. We're talking names,...

Continue Reading
DUVA ONE Sleep Earbuds: Real-Time Innovation Debuts

Updated Category News Views 0

While You Dream, DUVA ONE Works Here's the scoop: DUVA just took sleep tech to another level with their DUVA ONE earbuds launched at Berlin's IFA 2026. These aren't just any earbuds; they're engineered to actually do something while you're sleeping. DUVA ONE senses what’s happening during your snooze session and adjusts right on the fly. The Night Patrol: In-Ear and...

Continue Reading
Ice-Rock Avalanches: Future Risks and Urgent Lessons

Updated Category News Views 1

Mounting Threats in Mountain Chains That nightmare on August 26 at Mount Langtang Lirung in Nepal—where an ice-rock avalanche triggered a catastrophic mudslide—brought a harsh reminder that these mountains are cracking wide open. With 31 dead and over 500 souls still unaccounted for, it's a chilling warning about how vulnerable high-altitude regions have become. A...

Continue Reading
China Hour Expands Chinese Media Footprint in Africa

Updated Category News Views 3

An Ambitious Cross-Continental Media Play The airwaves are getting a new twist. This time, it's a blend of cultures, as China Hour makes an entrance in South Africa. That's right, folks—Jiangsu Broadcasting Corporation (JSBC) has set up camp alongside the South African Broadcasting Corporation (SABC), pushing a big media wave across the continent. If you've been...

Continue Reading
Auto Maintenance: Key Tips for Long-Term Vehicle Health

Updated Category News Views 3

Beating Breakdown Blues: Preventative Maintenance Insights You ever look under the hood and wonder what's ticking away? Cars ain't just about turning keys and hitting gas—there's a beating heart under all that metal and rubber. That's what HelloNation's serving us here, with David Mantz and his kid, David Mantz Jr., lifting the lid on preventative maintenance. These...

Continue Reading
Softcare Facilitates Standards Delegation Visit to Senegal

Updated Category News Views 1

Ever seen a whole nation's hygiene industry getting a deep dive from not just one, but three major standards bodies? That's what just went down in Senegal. Softcare opened its doors wide to folks from the Senegalese Association for Standardization (ASN), the International Organization for Standardization (ISO), and the Swedish Institute for Standards (SIS). This was no...

Continue Reading
MERACH Unveils W60 Plus: A Game Changer for Home Fitness

Updated Category News Views 1

MERACH's Ambitious Leap into European Markets Walking is one of life's simple pleasures, but it's not always convenient in our work-from-home driven world. That's where MERACH's UltraWalk W60 Plus comes in, dropping anchor in Europe like a brand new ship with all the bells and whistles. What makes this walking pad different, you ask? It's designed to become a natural...

Continue Reading
Creality Rolls Out K3, SPARKX i8 at IFA 2026

Updated Category News Views 4

Creality Struts Its Stuff at IFA 2026 You wouldn't guess 3D printing had anything left to dazzle us with, but Creality has sure put those notions to rest at the IFA 2026 in Berlin. They're rolling out the big guns with fresh tech that pushes both efficiency and sustainability—two big buzzwords these days—and ties a neat little bow on their innovative streak....

Continue Reading
Roborock Fuels Market Surge with 27.6% Revenue Boost

Updated Category News Views 1

Roborock's Rocket-Like Ascent in Global Markets Call me impressed, but Roborock is really hitting its stride. The company's been on a tear, pulling in RMB 10.084 billion during the first half of 2026—a remarkable 27.6% bump from last year. Not just content with the revenue surge, they also saw net profits jump 45.6%, making it pretty clear that they're not just playing...

Continue Reading
Mermaid Folklore Meets Revolution in New Short Film

Updated Category News Views 2

A Sea Haunting Like No Other Ever feel like history's forgotten tales deserve a fresh spin? Well, this one's shaking it up! Hoyt Dwyer, an Atlanta filmmaker, flips the script on a lesser-known bit from the American Revolution. Yeah, we're talking about Hessian soldiers and sirens here. Just hang on to your hats because this ain't your typical historical retelling. A...

Continue Reading

Top 5 Most Recently Viewed Articles

What Are the Five Foundations of Personal Finance?

Updated Category Personal Finance Views 117

Many adults report having high financial literacy, but survey results often show that actual scores on basic financial literacy questions are only around 50%, revealing a gap between perceived and tested knowledge. This disparity shows up when individuals navigate their first salary or experience rising household expenses. So, what are the five foundations of personal...

Continue Reading
Rivian Faces Challenges with Production Forecast Cut

Updated Category News Views 193

Rivian recently announced a significant adjustment to its full-year production forecast, revealing challenges that impacted its vehicle delivery capabilities. The company encountered a shortage of critical parts necessary for its R1 SUV, R1T pickups, and delivery vans. This shortage has been acute particularly since the third quarter. Stock Price Reactions: A Bearish...

Continue Reading
Euroseas Ltd. Expands Fleet with Charter Enhancement Details

Updated Category News Views 120

Euroseas Ltd. Enhances Fleet with New Charter for M/V Jonathan P Euroseas Ltd. (NASDAQ: ESEA) has recently made a significant announcement regarding its operational strategy. The company has secured a new time charter contract for the feeder containership M/V Jonathan P, originally built in 2006. This charter is set for a minimum duration of 11 months, with the...

Continue Reading
International Petroleum Corporation Plans New Bond Issuance

Updated Category News Views 198

Investor Meetings Announcement International Petroleum Corporation (IPC or the Corporation) is gearing up to arrange fixed income investor meetings as it plans for a new issuance of rated senior unsecured bonds. This initiative aims to refinance its existing outstanding bond, presenting an exciting opportunity for investors. Bond Issuance Details IPC has partnered with...

Continue Reading
Rob D'Alessandro Takes Charge as President at Meritus Gas

Updated Category News Views 182

Rob D'Alessandro Appointed Meritus Gas Partners President In an important development for Meritus Gas Partners LP, Rob D'Alessandro has been named President and Chief Operating Officer (COO). This strategic appointment aims to bolster the company’s leadership as it embarks on its next phase of growth. D'Alessandro, who has been a crucial figure in Meritus as Vice...

Continue Reading