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Last Post: 7/25/2014 8:03:27 AM - Followers: 1101 - Board type: Free - Posts Today: 7
 





(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
#139953   BMSN; is a super freak, super freak, it's lab40 07/25/14 08:03:26 AM
#139952   So true, even Jim Cramer said no one 02tampabay 07/25/14 04:48:47 AM
#139951   Chart looks good BDIY 07/25/14 04:36:43 AM
#139950   maybe he would rather keep control of the rverboatgambler 07/25/14 12:49:55 AM
#139949   Patience is the key and don't forget that PetePham 07/25/14 12:24:08 AM
#139948   Question is if that all comes to fruition OINGO BOINGO 07/25/14 12:20:21 AM
#139947   Like your thoughts here FINALY some one that inventor1 07/25/14 12:10:25 AM
#139946   I think he has one eye write them Angry Goat 07/24/14 11:42:03 PM
#139945   Thank you. At least you do know Peacefulwendy 07/24/14 11:13:44 PM
#139944   Stockchaser, the best of your posts is, you sante1 07/24/14 11:04:48 PM
#139943   did you not hear? It's around the corner. Angry Goat 07/24/14 10:46:16 PM
#139942   BMSN $$$$ Great DD! Thank you! cazual 07/24/14 10:43:10 PM
#139941   BMSN news will come together and yes...crabby dance Crabby1212 07/24/14 10:42:46 PM
#139940   BMSN $$$$ FDA Approval could be granted any cazual 07/24/14 10:41:46 PM
#139939   No. I think I will keep venting. the Beek 07/24/14 10:39:15 PM
#139938   BMSN-BMSN will visit Penny land soon!! Soon you ON-Fire 07/24/14 10:35:08 PM
#139937   OMG. It's like listening to teenage girls bitching kfox 07/24/14 10:34:53 PM
#139936   Oh what a nice fairy tale that you've the Beek 07/24/14 10:12:31 PM
#139935   Apparently the had a disagreement with a distributor FD2you 07/24/14 10:06:21 PM
#139934   Do you know what happened? Why the Peacefulwendy 07/24/14 09:53:31 PM
#139933   Let me present an alternative view to the LaddyMan 07/24/14 09:10:46 PM
#139932   Maybe you should have sent a dozen donuts instead. Natureboy1 07/24/14 09:04:29 PM
#139931   Sure could. Let's just hope it doesn't. FD2you 07/24/14 08:56:28 PM
#139930   That could easily happen here. IMO the Beek 07/24/14 08:55:13 PM
#139929   I'm still holding spinoff shares from about four FD2you 07/24/14 07:26:54 PM
#139928   I got filled at .0026 yesterday end of day. Abomb1357 07/24/14 06:46:24 PM
#139927   Good question. Abomb1357 07/24/14 06:44:58 PM
#139926   Thanks Crabby. Kbro13 07/24/14 05:41:38 PM
#139925   Is there a deadline on when they have Luck Of The Irish 07/24/14 05:23:10 PM
#139924   With ya Kbro, still...I've just been quiet lately....it's coming. BMSN Crabby1212 07/24/14 05:17:13 PM
#139923   50/50 chance here approved or not approved but Atstacksfor2 07/24/14 05:04:24 PM
#139922   Kbro, Wishful thinking, but ohmyohmy 07/24/14 04:22:03 PM
#139921   You know what I would love to see? Kbro13 07/24/14 04:16:50 PM
#139920   The beek, real cool man, real cool. ohmyohmy 07/24/14 04:00:18 PM
#139919   Another fantastic day here today of silence and the Beek 07/24/14 03:58:34 PM
#139918   you can take em at .0035 ohmyohmy 07/24/14 03:58:18 PM
#139917   All of you negative posters please sell me big loser 3 07/24/14 03:55:26 PM
#139916   BMSN STOCK charts are stuck and stockchaser64 07/24/14 03:49:27 PM
#139915   Dr. Sag has been invited by Regen Biopharma NEW4THIS 07/24/14 03:48:33 PM
#139914   It's time to hear what's happening with Regen. the Beek 07/24/14 03:47:06 PM
#139913   The problem with Koos that he overpays himself Atstacksfor2 07/24/14 03:45:51 PM
#139912   Value of regen shares is one thing. Another ADVFN_franknstein 07/24/14 03:36:58 PM
#139911   I have always been a realist about this the Beek 07/24/14 03:34:00 PM
#139910   The longer it takes the worse it looks. Atstacksfor2 07/24/14 03:33:41 PM
#139909   BMSN STOCK GOING no where so what stockchaser64 07/24/14 03:27:23 PM
#139908   you my friend are correct!!!!!......:) PARker1703 07/24/14 03:26:02 PM
#139907   Another terrible week gone by because you know wynston76 07/24/14 03:19:06 PM
#139906   ...for those who own regen shares and still NEW4THIS 07/24/14 03:17:18 PM
#139905   were you not just pumping this stock a PARker1703 07/24/14 03:11:33 PM
#139904   There is no point of knocking KOOS ohmyohmy 07/24/14 02:58:04 PM
PostSubject