Welcome!

News Feed Item

Regen BioPharma, a Majority Owned Subsidiary of Bio-Matrix Scientific Group, Provides Update on HemaXellerate I(TM) IND for Treatment of Drug Resistant Aplastic Anemia

Company Passes Manufacturing and Clinical Reviewers, Clarification of Safety Studies Requested by FDA

SAN DIEGO, CA -- (Marketwired) -- 05/12/14 -- Regen BioPharma Inc., a majority owned subsidiary of Bio-Matrix Scientific Group Inc. (PINKSHEETS: BMSN), announced today an update on its IND # 15376 for use of HemaXellerate I™ in treatment of patients with drug refractory aplastic anemia.

On March 6, 2014, Regen submitted a protocol modification, additional details on manufacturing, and new data to the FDA regarding therapeutic effects of HemaXellerate I™ in animal models of diseases similar to aplastic anemia in humans, as well as additional safety data.

The Company reports the FDA accepted the clinical protocol and the product manufacturing information provided, however, clarification on animal safety studies was requested.

"Given the HemaXellerate I™ product is derived from the patient's own fat tissue, and numerous key opinion leaders support clinical entry of our product, as demonstrated by our peer reviewed publication http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf., we are confident the safety studies the FDA requested clarification on can be addressed in a timely fashion," stated Thomas Ichim, Regen's Chief Scientific Officer and Board Member.

"The role of the FDA is to ensure the highest standards of safety for new products. We view the requested clarifications from the FDA in regards to safety studies as part of the normal process of FDA submission. Given that the HemaXellerate I™ possesses the potential to treat multiple conditions, we view the demonstration of safety as a fundamental step, which will position the Company to expand use of this 'stem cell drug' for multiple other indications," noted David Koos, the Company's Chairman & CEO. "Having passed the clinical trial protocol approval and the manufacturing approval, are major milestones for Regen."

On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.

About Regen BioPharma: Regen BioPharma, Inc., a majority owned subsidiary of Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN), is a biotechnology company focused on identifying undervalued regenerative medicine applications in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is focused on developing treatments for Aplastic Anemia and a gene silencing therapy for treating cancer. For more information refer to the company's website http://www.regenbiopharma.com/

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:

Bio-Matrix Scientific Group, Inc. and
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
619-702-1404
www.regenbiopharma.com

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
As Cybric's Chief Technology Officer, Mike D. Kail is responsible for the strategic vision and technical direction of the platform. Prior to founding Cybric, Mike was Yahoo's CIO and SVP of Infrastructure, where he led the IT and Data Center functions for the company. He has more than 24 years of IT Operations experience with a focus on highly-scalable architectures.
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
An edge gateway is an essential piece of infrastructure for large scale cloud-based services. In his session at 17th Cloud Expo, Mikey Cohen, Manager, Edge Gateway at Netflix, detailed the purpose, benefits and use cases for an edge gateway to provide security, traffic management and cloud cross region resiliency. He discussed how a gateway can be used to enhance continuous deployment and help testing of new service versions and get service insights and more. Philosophical and architectural ap...
DXWorldEXPO LLC announced today that Telecom Reseller has been named "Media Sponsor" of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Enterprises have taken advantage of IoT to achieve important revenue and cost advantages. What is less apparent is how incumbent enterprises operating at scale have, following success with IoT, built analytic, operations management and software development capabilities - ranging from autonomous vehicles to manageable robotics installations. They have embraced these capabilities as if they were Silicon Valley startups.
Wooed by the promise of faster innovation, lower TCO, and greater agility, businesses of every shape and size have embraced the cloud at every layer of the IT stack – from apps to file sharing to infrastructure. The typical organization currently uses more than a dozen sanctioned cloud apps and will shift more than half of all workloads to the cloud by 2018. Such cloud investments have delivered measurable benefits. But they’ve also resulted in some unintended side-effects: complexity and risk. ...
By 2021, 500 million sensors are set to be deployed worldwide, nearly 40x as many as exist today. In order to scale fast and keep pace with industry growth, the team at Unacast turned to the public cloud to build the world's largest location data platform with optimal scalability, minimal DevOps, and maximum flexibility. Drawing from his experience with the Google Cloud Platform, VP of Engineering Andreas Heim will speak to the architecture of Unacast's platform and developer-focused processes.
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
"I think DevOps is now a rambunctious teenager – it’s starting to get a mind of its own, wanting to get its own things but it still needs some adult supervision," explained Thomas Hooker, VP of marketing at CollabNet, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We are still a relatively small software house and we are focusing on certain industries like FinTech, med tech, energy and utilities. We help our customers with their digital transformation," noted Piotr Stawinski, Founder and CEO of EARP Integration, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Chris Matthieu is the President & CEO of Computes, inc. He brings 30 years of experience in development and launches of disruptive technologies to create new market opportunities as well as enhance enterprise product portfolios with emerging technologies. His most recent venture was Octoblu, a cross-protocol Internet of Things (IoT) mesh network platform, acquired by Citrix. Prior to co-founding Octoblu, Chris was founder of Nodester, an open-source Node.JS PaaS which was acquired by AppFog and ...
The Founder of NostaLab and a member of the Google Health Advisory Board, John is a unique combination of strategic thinker, marketer and entrepreneur. His career was built on the "science of advertising" combining strategy, creativity and marketing for industry-leading results. Combined with his ability to communicate complicated scientific concepts in a way that consumers and scientists alike can appreciate, John is a sought-after speaker for conferences on the forefront of healthcare science,...
"We focus on SAP workloads because they are among the most powerful but somewhat challenging workloads out there to take into public cloud," explained Swen Conrad, CEO of Ocean9, Inc., in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"The Striim platform is a full end-to-end streaming integration and analytics platform that is middleware that covers a lot of different use cases," explained Steve Wilkes, Founder and CTO at Striim, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...