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Last Post: 8/1/2014 9:43:29 AM - Followers: 1103 - Board type: Free - Posts Today: 13
 





(Majority-Owned Susidiary of BMSN)

Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (OTCBB: 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 andPhase I/ II clinical trials.

Stem Cell Medicine

 

"Our business model is to acquire and form companies around
undervalued assets identified froma highly focused analysis of issued
patents in regenerative medicinethat have demonstrated proof of 
concept"


 

Dr. Ichim is one of the leading authorities in the
world on stem cell bi
ology.

"A STEM CELL INCUBATOR COMPANY"

With an emphasis on stem cell regenerative medicine





 

Our Business Model | Regen BioPharma
                             

our business model 

Regen BioPharma has assessed over 20,000 stem cell related issued patents, narrowed down to 2000 patents with commercial applicability, and further identified 30 patents available for licensing. The company seeks to inlicense, take the product to, and through clinical safety and efficacy "signal" and spin out technologies.

 



 

Our Approach | Regen BioPharma

 

            

      REGEN BIOPHARMA AVOIDS WASTE OF "ONE PRODUCT/ONE INFRASTRUCTURE" APPROACH

      In the "Conventional Model", stem cell companies are started with one basic technology, infrastructure is developed around that                       technology, then if the technology fails, significant resources are lost that have been used in the product-specific development
 

             Conventional Model
conventional model

             Regen BioPharma Model
regen model







Operational Plan
 

Month 1-2: Assembly of Team:
Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization. -DONE
 
Month 1-4: Inlicensing of Intellectual Property:
The Company having already assessed over 20,000 issued patents and havingcompiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses onissued patents that have already passed preclinical studies but are not under clinical development. -DONE
 
Month 3-6: Interaction with Regulatory Agencies:
Regen intends to develop data packages for each of the technologies andinitiate interaction with Regulatory Agencies such as the FDA for initiation of trials.-DONE
 
Month 6-18: Clinical Implementation:
Regen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy.  NEXT UP
 
Month 18-24: Exit:
It is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.
 
 



"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."


 





Regen BioPharma Pipeline

 
HemaXellerate I™ FDA FILING
[Regen BioPharma filed an Investigational New Drug (IND) Application on February 5th, 2013.  Regen BioPharma has received approval from the FDA for the clinical protocol and the product manufacturing information for HemaXellerate I.  On May 9, 2014 Regen BioPharma submitted clarification on animal safety studies that the FDA requested with review anticipated within 30 days.]

HemaXellerate I is a cellular therapy designed to heal damaged bone marrow. HemaXellarate I utilizes a collection of cells harvested from the patient’s own adipose (fat) tissue to repair damaged bone marrow and stimulate production of blood cells . The initial application of HemaXellerate I will be the treatment of severe aplastic anemia, a rare and serious condition in which the bone marrow fails to make enough blood cells: red blood cells, white blood cells, and platelets. In practice, the physician is shipped a kit, which is used to collect adipose tissue. The tissue is sent to a processing facility, and a standardized cellular product is delivered in a ready-to-use manner for administration into the patient intravenously.

**The Company intends to seek Orphan Drug Designation under the Orphan Drug Act of 1983 from the US Food and Drug Administration for HemaXellerate I**

 
dCellVax™
[Regen BioPharma is currently in the preclinical stage of development for dCellVax and plans to file an Investigational New Drug Application in August 2014]

The dCellVax therapeutic product is based on extracting blood from patients, growing a specialized type of immune cell from the blood called the "dendritic cell" and then subsequently genetically modifying the dendritic cell to become resistant to cancer's immune suppressive activity. It is known that cancer modifies the immune system by producing proteins which result in immune suppression. One such protein which cancer stimulates is an enzyme, indolamine 2,3 deoxygenase (IDO), which cancer turns on in dendritic cells. While dendritic cells are usually immune stimulators, dendritic cells found in cancer patients suppress the immune system as a result of expressing IDO.

The dCellVax therapeutic product uses patents that Regen BioPharma has in-licensed from Dr. Wei-Ping Min coupled with patents in-licensed from Benitec BioPharma.  By utilizing methods covered in both of these patents Regen BioPharma hopes to develop an immune-based, non-toxic cancer treatment initially targeting breast cancer.

HemaXellerate II™
[Regen BioPharma is currently in the preclinical stage of development for HemaXellerate II]

HemaXellerate II is intended to be a universal donor endothelial cell based therapeutic and is intended to be manufactured by obtaining cells from a part of the placenta called the “vascular lobules”. The cells are processed and utilized for the purpose of stimulating bone marrow hematopoetic stem cell repair and proliferation. The mechanism of action for HemaXellerate II is similar to HemaXellerate I whereby the harvested and processed cells would produce growth factors which would mediate the therapeutic effects of the product.

 



Managent Team | Regen BioPharma
 


David R. Koos, PhD, DBA

Chairman and Chief Executive Officer

David Koos is the Founder, Chairman & CEO of Entest BioMedical Inc. Dr. Koos has over 26 years of investment banking and venture capital experience with a primary focus on fully reporting medical and biotechnology ventures. He holds a Ph.D. degree in Sociology and a Doctor of Business Administration in Finance. Additionally, he has authored or co-authored several peer reviewed journal articles primarily on biotechnology related subjects.




Thomas E. Ichim, PhD

Chief Scientific Officer and Board Member

Dr. Ichim is a seasoned biotechnology entrepreneur with a track record of scientific excellence. He has founded/co-founded several companies including Medvax Pharma Corp, ToleroTech Inc, bioRASI, and OncoMune LLC. Dr. Ichim is a member of Vendevia Group, an innovative venture development organization focused on optimization of value in biotechnology ventures. He is scientific advisor to Orcrist Bio, Entest, and MBVaX. To date he has published 91 peer-reviewed articles and is co-editor of the textbook “RNA Interference: From Bench to Clinical Translation”. Ichim is an ad-hoc editor and sits on several editorial boards. Ichim is inventor on over 30 patents and patent applications. CV

 



Advisory Board | Regen BioPharma



Weiping Min, M.D.

Dr. Min is Associate Professor, Department of Surgery at the University of Western Ontario. His clinical research is focused on using siRNA to inhibit disease modalities, including cancer and organ rejection. He earned graduate and medical degrees from Nanchang University Medical School and the Ph.D. degree from Kyushu University.



David James Graham White, M.D., Ph.D.

Dr. White is a member of the Surgery and Immunology faculty of The Schulic School of Medicine, University of Western Ontario. He is one of the leading experts on using regenerative medicine transplant procedures to treat pancreatic conditions, including diabetes. He is also the Chief Scientific Officer of Sernova Corp and was formerly a Therapeutic Area Head for Novartis. He received the B.Sc. degree from the University of Surrey and the M.D. and Ph.D. degrees from Cambridge University.

David A. Suhy, PhD

Dr Suhy has a long-term interest in development of shRNA based therapeutics to treat human diseases. He is in the unique position of seeing of directing the research of a RNAi-based therapeutic from its earliest inception until it reaches clinical trials. Development of a shRNA therapeutic against the Hepatitis C virus (HCV) was initiated at Avocel in 2003. Financial constraints caused the company to shutter research operations in 2006.Upon raising venture capital, Tacere Therapeutics acquired the rights to the HCV family of drugs and brought back Dr. Suhy to head the program. Partnered with Pfizer shortly thereafter, this drug is their first foray into gene therapy-based approaches and is the first shRNA program partnered with a large pharma. Given Pfizer’s lack of experience in both areas, Dr. Suhy has played a pivotal role in its development as Tacere has continued to lead the research efforts for advancement of this product into the clinic and has stood side-by-side with Pfizer through all of the regulatory agency meetings.





 

Current Business Partners | Regen BioPharma

 
                                                                
                                         
   

 


 


 

                        News and Recent Press Releases:
 

05/12/2014 12:30 Regen Biopharma, a Majority Owned Subsidiary of Bio-Matrix Scientific Group, Provides Update on HemaXellerate I(TM) IND...
03/06/2014 14:53 Bio-Matrix Scientific Group Inc. Announces Dividend Record Date to Receive Shares in Subsidiary, Regen BioPharma, Inc.
12/11/2013 09:35 Regen BioPharma Announces HemaXellerate I (TM) Efficacy Data in Animal Model of Aplastic Anemia

10/31/2013 11:35 Bio-Matrix Scientific Group's Regen BioPharma Retains Cook General Biotechnology for Contract Manufacturing of HemaXellerate I
10/09/2013 15:11 Bio-Matrix Scientific Group Inc. Announces 20 Million Share Regen BioPharma Dividend to Be Paid to Shareholders
09/26/2013 08:00 Bio-Matrix Scientific Group's Subisidiary Regen BioPharma Enters Into Preclinical Trials Agreement for HemaXellerate I..
09/25/2013 08:30 Bio-Matrix Scientific Group's Subsidiary Regen BioPharma Announces dCellVax Breast Cancer Immunotherapeutic Product
09/17/2013 10:06 Bio-Matrix Scientific Group Recruits RNA Interference Pioneer Dr. David Suhy to Regen BioPharma Inc.'s Scientific Advisor Board
08/16/2013 13:47 Bio-Matrix Scientific Group Discusses Regen BioPharma's Cancer Immunotherapy Program
08/08/2013 09:47 Regen BioPharma Inc. Licenses Cancer Gene Silencing Technology From Benitec BioPharma
07/31/2013 14:36 Bio-Matrix Scientific Group Provides Update on Its Regen BioPharma's HemaXellerate I (TM) Clinical Program
06/07/2013 08:30 Bio-Matrix Scientific Group's Regen BioPharma Submits Response to FDA Questions Regarding HemaXellerate Clinical Program
05/06/2013 08:30 Bio-Matrix Scientific Group's Regen BioPharma Acquires Cancer Vaccine Technology With Initial Focus on Breast Cancer
04/04/2013 16:09 Bio-Matrix Scientific Group's Regen BioPharma Provides Update on Preclinical and Clinical Development
03/18/2013 09:57 Regen BioPharma Receives IND # From FDA for HemaXellerate
02/26/2013 10:12 Bio-Matrix Scientific Group's Regen BioPharma Executes LOI to Acquire Issued US Patent Covering Cancer Gene-Silencing...
02/05/2013 10:35 Regen BioPharma Files Investigational New Drug (IND) Application With FDA on HemaXellerate I (TM) Stem Cell Drug For Aplastic...
01/24/2013 14:53 Regen BioPharma Peer-Reviewed Publication Provides Preclinical Support for HemaXellerate (TM) Bone Marrow Failure Product




  


























 


 
 
 
(Majority-Owned Susidiary of BMSN)

Overview

Entest BioMedical Inc.(OTCQB: ENTB) develops immuno-therapeutic treatments that address illnesses and maladies in both veterinary and human medicine.  Of specific interest to us are immunological vaccines for oncology (cancer vaccines) and veterinary clinic acquisitions.  The basis for the majority of our approaches is underpinned by leveraging the body's own reparative / immunological mechanisms - as opposed to using toxic chemicals.

Areas of Focus
 
Currently, Entest is focused on significant therapeutic therapies that show promise for the development of under-served market niches with potential high demand.

 


BMSN Transfer Agent:
Securities Transfer Corporation

2591 Dallas Parkway Suite 102

Frisco, Texas 75034

Phone - 469-633-0101

FAX 469-633-0088

 
PostSubject
#139335  Sticky Note BMSN FOLKS (READ HERE: DD).... PetePham 07/14/14 11:51:06 PM
#136931  Sticky Note BMSN*Valuation(s), FDA, & Orphan Drug Thoughts… cazual 06/18/14 10:19:05 AM
#134995  Sticky Note Please stay on topic. The only topic to IH Admin [Dan] 06/03/14 05:06:37 PM
#133857  Sticky Note Excellent Find by NEW4THIS: Dr V 05/23/14 07:56:10 AM
#132160  Sticky Note Updated BMSN/Regen BioPharma Timeline for IND Approval According The PoPo 05/12/14 03:01:43 PM
#140333   Koo wants the short sale interest sup105 08/01/14 09:43:29 AM
#140332   ~ BMSN = Chart = Downtrend Continues!! :-( 1-eye-jack 08/01/14 09:41:03 AM
#140330  Restored ~ BMSN = ZZZZzzzzz~ :-( News Tomorrow? 1-eye-jack 08/01/14 09:18:58 AM
#140329   Agree. Keep the eye on the prize. Bare1 08/01/14 08:56:18 AM
#140328   No, it's good....we are in great shape time Crabby1212 08/01/14 08:49:20 AM
#140327   link showing short action on our BMSN: rverboatgambler 08/01/14 08:30:19 AM
#140326   Or should I just say, "Welcome to Pennyland" Kbro13 08/01/14 08:25:33 AM
#140325   3 massive PR's in 7 months really doesn't Kbro13 08/01/14 08:19:13 AM
#140324   Ive been here nearly 2 years, this is manjensen 08/01/14 05:11:31 AM
#140323   I hope so... BDIY 08/01/14 05:01:02 AM
#140322   BMSN stock upward trend will continue JACK all PetePham 08/01/14 02:21:47 AM
#140320   In minutes it will be the 1st of Atstacksfor2 07/31/14 11:49:01 PM
#140319   I don't agree with any of that. But, kfox 07/31/14 10:18:37 PM
#140318   Your opinion as well as mine are as jayreese 07/31/14 09:29:06 PM
#140315   I was one of them. Completely expected Kbro13 07/31/14 08:38:41 PM
#140312   I know this has nothing to do with Atstacksfor2 07/31/14 07:51:12 PM
#140309   BMSN AND it sister company both are in stockchaser64 07/31/14 06:56:02 PM
#140307   Sideways trend before the news. BM$N will see luke37 07/31/14 06:13:45 PM
#140306   BMSN STOCK downward trend will continue JACK all stockchaser64 07/31/14 05:55:49 PM
#140305   haha. Yeah I believe some said that the Beek 07/31/14 05:15:29 PM
#140304   ~ BMSN = Yes,, you arRre CorRrect, $ir! ;-) 1-eye-jack 07/31/14 04:25:56 PM
#140303   Interesting month here without PR. Kbro13 07/31/14 04:13:38 PM
#140302   I know the feeling Beek, but I have rverboatgambler 07/31/14 04:10:43 PM
#140301   Yes it's a strong sell Atstacksfor2 07/31/14 04:06:38 PM
#140300   BMSN STOCK GOING no were sir tomorrow could stockchaser64 07/31/14 04:02:32 PM
#140299   Another month gone by and another disappointment. the Beek 07/31/14 03:59:41 PM
#140293   Clever, but no. I told you I'm the Beek 07/31/14 02:44:20 PM
#140292   The BMSN board (bored) rhyming game. LaddyMan 07/31/14 02:17:00 PM
#140291   How is the south beach party list looking? the Beek 07/31/14 02:06:17 PM
#140290   To answer your question, yes I want a the Beek 07/31/14 01:55:52 PM
#140289   BMSN-Ya think he wants this to get FDA ON-Fire 07/31/14 01:34:56 PM
#140288   BMSN YEP jack look like you call it stockchaser64 07/31/14 01:30:31 PM
#140287   Bingo....he didn't do that to lose. BMSN Crabby1212 07/31/14 01:10:55 PM
#140286   So, you want a fluff PR and waste kfox 07/31/14 01:10:12 PM
#140285   BMSN 52 WEEK LOW WAS .0011 and the stockchaser64 07/31/14 01:05:13 PM
#140283   BMSN STOCK JACK going into the .000 range stockchaser64 07/31/14 12:49:15 PM
#140282   My only post of the day. belgiumsui 07/31/14 12:45:08 PM
#140281   BMSN stock jack this article sum it up stockchaser64 07/31/14 12:36:46 PM
#140279   BMSN STOCK CHARTS pointing lower jack this stock stockchaser64 07/31/14 12:24:46 PM
#140278   Even with FDA news pending, this ohmyohmy 07/31/14 11:52:38 AM
#140277   First 300k, now another 500k @0,0025 ita-elios 07/31/14 11:43:18 AM
#140276   I don't any more DD than this. http://www.secform4.com/insider-trading/1079282 Lahori 07/31/14 11:40:32 AM
#140275   don't forget:FDA approval could be ANY day now! rverboatgambler 07/31/14 11:37:16 AM
#140272   As far as I can tell, the FDA Canadian Trader 07/31/14 11:33:12 AM
#140268   Oh forget FDA approval. They have dragged the Beek 07/31/14 11:23:37 AM
#140267   ~ BMSN = 0.0024 -0.0001 (-4.00%)LOD..so..farRr! :-( 1-eye-jack 07/31/14 11:23:32 AM
#140266   I have yelled from the mountaintop for ever Angry Goat 07/31/14 11:20:02 AM
#140265   Koosday - Newsday !!!! ADVFN_franknstein 07/31/14 11:03:23 AM
#140263   TheBeek:) I thought I saw you ohmyohmy 07/31/14 10:52:03 AM
#140262   I'll use a soup nazi line to answer the Beek 07/31/14 10:42:25 AM
PostSubject