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Damn, you got me! :-p Happy April Fool's Day!
Awesome stuff GM, thanks for sharing! :)
$ RGBP $
The Orphan application has the best chance of success now - after the FDA has already approved the initiation of their Phase I clinical trial. The orphan designation assists with clinical development (i.e., funding, tax credits) and post-clinical market protection, so it's fair to see the application at this stage when it's known that they'll be pursuing clinical trials.
$ RGBP $
SUMMARY OF HEMAXELLERATE PROGRESS (UPDATED JAN 2016):
Jan 24, 2013 - Pre-clinical proof of concept and plan to file IND.
http://ih.advfn.com/p.php?pid=nmona&article=55986712
Feb 5, 2013 - Announcement that IND was filed.
http://ih.advfn.com/p.php?pid=nmona&article=56150687
Mar 18, 2013 - Regen receives IND# from FDA.
http://ih.advfn.com/p.php?pid=nmona&article=56788567
Apr 4, 2013 - FDA will send a letter outlining items which must be addressed prior to initiating clinical trials.
http://ih.advfn.com/p.php?pid=nmona&article=57035344
Jun 6, 2013 - Regen responds to FDA questions (including new data).
http://ih.advfn.com/p.php?pid=nmona&article=57897013
Jul 31, 2013 - Regen in second round of discussion with FDA on a new set of FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=58628844
Sept 26, 2013 - Agreement for pre-clinical animal trials with WP Min to address FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=59372541
Oct 31, 2013 - Cook General Biotechnology to continue producing clinical grade HemaXellerate for pre-clinial and clinical studies.
http://ih.advfn.com/p.php?pid=nmona&article=59847939
Dec 11, 2013 - Update on WP Min work regarding pre-clinical animal studies
http://ih.advfn.com/p.php?pid=nmona&article=60352616
May 12, 2014 - FDA accepted the clinical protocol and the product manufacturing information; clarification on animal safety studies was requested.
http://ih.advfn.com/p.php?pid=nmona&article=62167863
Sept 10, 2014 - Regen to submit additional safety data from a GLP-certified lab prior to initiating clinical trials.
http://www.marketwired.com/press-release/regen-biopharma-provides-update-on-hemaxellerate-ind-progress-after-conference-call-otcbb-rgbp-1945965.htm
Oct 6, 2014 - Experimental protocol submitted to FDA regarding proposed pre-clinical experiments; follow-up from previous PR.
http://www.marketwired.com/press-release/regen-biopharma-submits-experimental-protocol-fda-hemaxellerate-aplastic-anemia-trial-otcbb-rgbp-1954889.htm
Oct 14, 2014 - Dr. Amit Patel Joins Scientific Advisory Board, has experience in over 17 FDA trials; will assist Regen with HemaXellerate and dCellVax.
http://www.marketwired.com/press-release/cell-therapy-expert-dr-amit-patel-joins-regen-biopharma-inc-scientific-advisory-board-otcbb-rgbp-1957807.htm
Jan 14, 2015 - Progress update for 2015; FDA is reviewing protocols for HemaXellerate GLP safety study.
http://www.marketwired.com/press-release/regen-biopharma-inc-provides-update-on-companys-progress-areas-specialization-2015-otcbb-rgbp-1982809.htm
Mar 17, 2015 - Regen received final comments and authorization from the FDA to proceed with the GLP safety study; clinical trial anticipated to begin once GLP data is reviewed by the FDA.
http://www.marketwired.com/press-release/regen-receives-green-light-from-fda-proceed-with-glp-safety-study-support-its-hemaxellerate-otcbb-rgbp-2001028.htm
Apr 7, 2015 - Thomas Ichim will present a poster entitled "HEMAXELLERATE I™, AUTOLOGOUS ADIPOSE STROMAL VASCULAR FRACTION CELLS, FOR SEVERE APLASTIC ANEMIA" at the 13th International Symposium on Myelodysplastic Syndromes. RGBP also has two other presentations scheduled for this symposium.
http://www.marketwired.com/press-release/regen-biopharma-inc-present-multiple-presentations-13th-international-symposium-on-myelodysplastic-otcbb-rgbp-2007259.htm
Apr 13, 2015 - Selection process of potential GLP labs (for HemaXellerate safety study) narrowed down to two candidates.
http://www.marketwired.com/press-release/regen-biopharma-narrows-selection-cro-candidates-hemaxellerate-glp-safety-studies-requested-2008917.htm
Apr 22, 2015 - Regen selects Charles River Laboratories to carry out the GLP safety study for HemaXellerate. Expected to be last phase of experimentation before clinical trials can begin.
http://www.marketwired.com/press-release/regen-biopharma-inc-engages-charles-river-laboratories-initiate-fda-requested-study-otcbb-rgbp-2012279.htm
Sept 25, 2015 - Regen receives audited draft report from Charles River showing no adverse effects in 10X dose of HemaXellerate in animal safety study. Expected 10-patient clinical trial forthcoming.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-announces-positive-results-from-glp-safety-study-for-hemaxellerate-529494211.html
Nov 17, 2015 - Regen submits response (including GLP preclinical toxicology data from CRL) to the FDA. Expecting FDA clearance to begin HemaXellerate clinical trial.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-submits-response-to-fda-questions-on-hemaxellerate-investigational-new-drug-application-550996231.html
** FDA APPROVAL!!! **
Dec 15, 2015 - Regen BioPharma Receives FDA Clearance to Initiate Clinical Trial of HemaXellerate.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-receives-fda-clearance-to-initiate-clinical-trial-of-hemaxellerate-562342421.html
Jan 13, 2016 - Open Letter from Harry Lander; Regen will likely partner with a Contract Research Organization (CRO) for Phase I clinical trial of HemaXellerate, and expects to begin by Q3 2016. Expects FDA to grant Orphan Drug Status.
http://www.prnewswire.com/news-releases/regen-biopharma-president-harry-lander-provides-open-letter-to-shareholders-on-companys-progress-and-developments-565124901.html
Jan 26, 2016 - Application to FDA for Orphan Drug Designation of HemaXellerate.
http://www.prnewswire.com/news-releases/regen-biopharma-submits-application-to-fda-for-orphan-drug-designation-for-its-hemaxellerate-product-566539361.html
** All dates listed above refer to the date of the linked PR **
$ RGBP $
That's absolutely not a problem. Keep in mind that to start a Phase I clinical trial they need real human people who will be treated using HemaXellerate. It's not at all surprising that they'd need several months to lock that down, including a location.
$ RGBP $
SUMMARY OF HEMAXELLERATE PROGRESS (UPDATED JAN 2016):
Jan 24, 2013 - Pre-clinical proof of concept and plan to file IND.
http://ih.advfn.com/p.php?pid=nmona&article=55986712
Feb 5, 2013 - Announcement that IND was filed.
http://ih.advfn.com/p.php?pid=nmona&article=56150687
Mar 18, 2013 - Regen receives IND# from FDA.
http://ih.advfn.com/p.php?pid=nmona&article=56788567
Apr 4, 2013 - FDA will send a letter outlining items which must be addressed prior to initiating clinical trials.
http://ih.advfn.com/p.php?pid=nmona&article=57035344
Jun 6, 2013 - Regen responds to FDA questions (including new data).
http://ih.advfn.com/p.php?pid=nmona&article=57897013
Jul 31, 2013 - Regen in second round of discussion with FDA on a new set of FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=58628844
Sept 26, 2013 - Agreement for pre-clinical animal trials with WP Min to address FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=59372541
Oct 31, 2013 - Cook General Biotechnology to continue producing clinical grade HemaXellerate for pre-clinial and clinical studies.
http://ih.advfn.com/p.php?pid=nmona&article=59847939
Dec 11, 2013 - Update on WP Min work regarding pre-clinical animal studies
http://ih.advfn.com/p.php?pid=nmona&article=60352616
May 12, 2014 - FDA accepted the clinical protocol and the product manufacturing information; clarification on animal safety studies was requested.
http://ih.advfn.com/p.php?pid=nmona&article=62167863
Sept 10, 2014 - Regen to submit additional safety data from a GLP-certified lab prior to initiating clinical trials.
http://www.marketwired.com/press-release/regen-biopharma-provides-update-on-hemaxellerate-ind-progress-after-conference-call-otcbb-rgbp-1945965.htm
Oct 6, 2014 - Experimental protocol submitted to FDA regarding proposed pre-clinical experiments; follow-up from previous PR.
http://www.marketwired.com/press-release/regen-biopharma-submits-experimental-protocol-fda-hemaxellerate-aplastic-anemia-trial-otcbb-rgbp-1954889.htm
Oct 14, 2014 - Dr. Amit Patel Joins Scientific Advisory Board, has experience in over 17 FDA trials; will assist Regen with HemaXellerate and dCellVax.
http://www.marketwired.com/press-release/cell-therapy-expert-dr-amit-patel-joins-regen-biopharma-inc-scientific-advisory-board-otcbb-rgbp-1957807.htm
Jan 14, 2015 - Progress update for 2015; FDA is reviewing protocols for HemaXellerate GLP safety study.
http://www.marketwired.com/press-release/regen-biopharma-inc-provides-update-on-companys-progress-areas-specialization-2015-otcbb-rgbp-1982809.htm
Mar 17, 2015 - Regen received final comments and authorization from the FDA to proceed with the GLP safety study; clinical trial anticipated to begin once GLP data is reviewed by the FDA.
http://www.marketwired.com/press-release/regen-receives-green-light-from-fda-proceed-with-glp-safety-study-support-its-hemaxellerate-otcbb-rgbp-2001028.htm
Apr 7, 2015 - Thomas Ichim will present a poster entitled "HEMAXELLERATE I™, AUTOLOGOUS ADIPOSE STROMAL VASCULAR FRACTION CELLS, FOR SEVERE APLASTIC ANEMIA" at the 13th International Symposium on Myelodysplastic Syndromes. RGBP also has two other presentations scheduled for this symposium.
http://www.marketwired.com/press-release/regen-biopharma-inc-present-multiple-presentations-13th-international-symposium-on-myelodysplastic-otcbb-rgbp-2007259.htm
Apr 13, 2015 - Selection process of potential GLP labs (for HemaXellerate safety study) narrowed down to two candidates.
http://www.marketwired.com/press-release/regen-biopharma-narrows-selection-cro-candidates-hemaxellerate-glp-safety-studies-requested-2008917.htm
Apr 22, 2015 - Regen selects Charles River Laboratories to carry out the GLP safety study for HemaXellerate. Expected to be last phase of experimentation before clinical trials can begin.
http://www.marketwired.com/press-release/regen-biopharma-inc-engages-charles-river-laboratories-initiate-fda-requested-study-otcbb-rgbp-2012279.htm
Sept 25, 2015 - Regen receives audited draft report from Charles River showing no adverse effects in 10X dose of HemaXellerate in animal safety study. Expected 10-patient clinical trial forthcoming.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-announces-positive-results-from-glp-safety-study-for-hemaxellerate-529494211.html
Nov 17, 2015 - Regen submits response (including GLP preclinical toxicology data from CRL) to the FDA. Expecting FDA clearance to begin HemaXellerate clinical trial.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-submits-response-to-fda-questions-on-hemaxellerate-investigational-new-drug-application-550996231.html
** FDA APPROVAL!!! **
Dec 15, 2015 - Regen BioPharma Receives FDA Clearance to Initiate Clinical Trial of HemaXellerate
http://www.prnewswire.com/news-releases/regen-biopharma-inc-receives-fda-clearance-to-initiate-clinical-trial-of-hemaxellerate-562342421.html
Jan 13, 2016 - Open Letter from Harry Lander; Regen will likely partner with a Contract Research Organization (CRO) for Phase I clinical trial of HemaXellerate, and expects to begin by Q3 2016. Expects FDA to grant Orphan Drug Status.
http://www.prnewswire.com/news-releases/regen-biopharma-president-harry-lander-provides-open-letter-to-shareholders-on-companys-progress-and-developments-565124901.html
** All dates listed above refer to the date of the linked PR **
$ RGBP $
Big year-end move happening right now! :)
$ RGBP $
Nice 8-K today! RGBP 12 Days of Xmas!!
$ RGBP $
Give it some time man! Hasn't even been open for an hour; word will spread in due time.
$ RGBP $
Hi Meach, could you please replace sticky 20095 with post 21467
$ Go RGBP ! $
SUMMARY OF HEMAXELLERATE PROGRESS (UPDATED DEC 2015):
Jan 24, 2013 - Pre-clinical proof of concept and plan to file IND.
http://ih.advfn.com/p.php?pid=nmona&article=55986712
Feb 5, 2013 - Announcement that IND was filed.
http://ih.advfn.com/p.php?pid=nmona&article=56150687
Mar 18, 2013 - Regen receives IND# from FDA.
http://ih.advfn.com/p.php?pid=nmona&article=56788567
Apr 4, 2013 - FDA will send a letter outlining items which must be addressed prior to initiating clinical trials.
http://ih.advfn.com/p.php?pid=nmona&article=57035344
Jun 6, 2013 - Regen responds to FDA questions (including new data).
http://ih.advfn.com/p.php?pid=nmona&article=57897013
Jul 31, 2013 - Regen in second round of discussion with FDA on a new set of FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=58628844
Sept 26, 2013 - Agreement for pre-clinical animal trials with WP Min to address FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=59372541
Oct 31, 2013 - Cook General Biotechnology to continue producing clinical grade HemaXellerate for pre-clinial and clinical studies.
http://ih.advfn.com/p.php?pid=nmona&article=59847939
Dec 11, 2013 - Update on WP Min work regarding pre-clinical animal studies
http://ih.advfn.com/p.php?pid=nmona&article=60352616
May 12, 2014 - FDA accepted the clinical protocol and the product manufacturing information; clarification on animal safety studies was requested.
http://ih.advfn.com/p.php?pid=nmona&article=62167863
Sept 10, 2014 - Regen to submit additional safety data from a GLP-certified lab prior to initiating clinical trials.
http://www.marketwired.com/press-release/regen-biopharma-provides-update-on-hemaxellerate-ind-progress-after-conference-call-otcbb-rgbp-1945965.htm
Oct 6, 2014 - Experimental protocol submitted to FDA regarding proposed pre-clinical experiments; follow-up from previous PR.
http://www.marketwired.com/press-release/regen-biopharma-submits-experimental-protocol-fda-hemaxellerate-aplastic-anemia-trial-otcbb-rgbp-1954889.htm
Oct 14, 2014 - Dr. Amit Patel Joins Scientific Advisory Board, has experience in over 17 FDA trials; will assist Regen with HemaXellerate and dCellVax.
http://www.marketwired.com/press-release/cell-therapy-expert-dr-amit-patel-joins-regen-biopharma-inc-scientific-advisory-board-otcbb-rgbp-1957807.htm
Jan 14, 2015 - Progress update for 2015; FDA is reviewing protocols for HemaXellerate GLP safety study.
http://www.marketwired.com/press-release/regen-biopharma-inc-provides-update-on-companys-progress-areas-specialization-2015-otcbb-rgbp-1982809.htm
Mar 17, 2015 - Regen received final comments and authorization from the FDA to proceed with the GLP safety study; clinical trial anticipated to begin once GLP data is reviewed by the FDA.
http://www.marketwired.com/press-release/regen-receives-green-light-from-fda-proceed-with-glp-safety-study-support-its-hemaxellerate-otcbb-rgbp-2001028.htm
Apr 7, 2015 - Thomas Ichim will present a poster entitled "HEMAXELLERATE I™, AUTOLOGOUS ADIPOSE STROMAL VASCULAR FRACTION CELLS, FOR SEVERE APLASTIC ANEMIA" at the 13th International Symposium on Myelodysplastic Syndromes. RGBP also has two other presentations scheduled for this symposium.
http://www.marketwired.com/press-release/regen-biopharma-inc-present-multiple-presentations-13th-international-symposium-on-myelodysplastic-otcbb-rgbp-2007259.htm
Apr 13, 2015 - Selection process of potential GLP labs (for HemaXellerate safety study) narrowed down to two candidates.
http://www.marketwired.com/press-release/regen-biopharma-narrows-selection-cro-candidates-hemaxellerate-glp-safety-studies-requested-2008917.htm
Apr 22, 2015 - Regen selects Charles River Laboratories to carry out the GLP safety study for HemaXellerate. Expected to be last phase of experimentation before clinical trials can begin.
http://www.marketwired.com/press-release/regen-biopharma-inc-engages-charles-river-laboratories-initiate-fda-requested-study-otcbb-rgbp-2012279.htm
Sept 25, 2015 - Regen receives audited draft report from Charles River showing no adverse effects in 10X dose of HemaXellerate in animal safety study. Expected 10-patient clinical trial forthcoming.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-announces-positive-results-from-glp-safety-study-for-hemaxellerate-529494211.html
Nov 17, 2015 - Regen submits response (including GLP preclinical toxicology data from CRL) to the FDA. Expecting FDA clearance to begin HemaXellerate clinical trial.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-submits-response-to-fda-questions-on-hemaxellerate-investigational-new-drug-application-550996231.html
** FDA APPROVAL!!! **
Dec 15, 2015 - Regen BioPharma Receives FDA Clearance to Initiate Clinical Trial of HemaXellerate
http://www.prnewswire.com/news-releases/regen-biopharma-inc-receives-fda-clearance-to-initiate-clinical-trial-of-hemaxellerate-562342421.html
** All dates listed above refer to the date of the linked PR **
$ RGBP $
APPROVAL!!! Congrats to everyone who held during the long road to approval!
$ RGBP $
It was at the bottom, in the letter to Jonathan Baell regarding the Scientific Advisory Board. So might not carry too much meaning, but it's something. Here's the full section:
August 4, 2015
Dear Jonathan
This letter is a follow up to our previous discussion about the Scientific Advisory Board for Regen BioPharma, Inc. The function of the Scientific Advisory Board is to review research directions that Regen BioPharma, Inc. may undertake, determining those projects which may lead to future developments/advancements in the field of stem cell therapy. Other areas may be pursued as well, with advice from this advisory board.
You will receive 100,000 shares of Regen Biopharma, Series A Preferred Stock.Regen’s common stock currently trades on the OTC Bulletin Board. The Company anticipates obtaining a stock symbol for the Series A preferred in the near future. The 100,000 shares of Biopharma, Series A Preferred shares are consideration for participating in telephonic calls/conference calls and serving on Regen BioPharma, Inc.’s Scientific Advisory Board. Under this SAB agreement ,the frequency and timing of such calls will be approximately one call every month
Additionally, this agreement may be renewed by mutual consent each year on its anniversary date for a maximum of 2 additional years. The compensation on renewal will be another payment of 100,000 Series A preferred stock in Regen on each anniversary that this contract is renewed by the Company.
It is anticipated that members of the Scientific Advisory Board will potentially serve as primary research consultants to the Company as such projects are undertaken. Compensation for such projects will be negotiated separately on a case-by-case basis between the Company and the consultant.
Thank You for your consideration.
David R. Koos
Chairman and CEO
P.S.: Please sign this letter in your acceptance and fax back to me at 619-330-2328. Any usage of your name in any press releases will be submitted to you for review and comment before being released to the public.
"The Company anticipates obtaining a stock symbol for the Series A preferred in the near future."
From the Nov 24, 2015 8-k
http://ih.advfn.com/p.php?pid=nmona&article=69458566&symbol=RGBP
$ RGBP $
EOD trades under 3k shares don't cut down trees...
Besides, assuming the data package satisfies the FDA, we'll know of approval by Mid December if not earlier. In the case of approval, whoever cut down this tree today is going to be planting a lot more in the future (if that makes any sense; I don't speak Lumberjack!).
$ RGBP $
Hi Meach, would you be able to replace sticky 18107 with post 20095 ? :)
Mods, replace sticky 18107 with post 20095 please :)
That sounds like a fair guess! Glad to see an update on this one today. Now that there is positive preclinical GLP toxicity data, I won't know what to think if this gets held up again! Hoping for approval.
$ RGBP $
SUMMARY OF HEMAXELLERATE PROGRESS (UPDATED NOV 2015):
Jan 24, 2013 - Pre-clinical proof of concept and plan to file IND.
http://ih.advfn.com/p.php?pid=nmona&article=55986712
Feb 5, 2013 - Announcement that IND was filed.
http://ih.advfn.com/p.php?pid=nmona&article=56150687
Mar 18, 2013 - Regen receives IND# from FDA.
http://ih.advfn.com/p.php?pid=nmona&article=56788567
Apr 4, 2013 - FDA will send a letter outlining items which must be addressed prior to initiating clinical trials.
http://ih.advfn.com/p.php?pid=nmona&article=57035344
Jun 6, 2013 - Regen responds to FDA questions (including new data).
http://ih.advfn.com/p.php?pid=nmona&article=57897013
Jul 31, 2013 - Regen in second round of discussion with FDA on a new set of FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=58628844
Sept 26, 2013 - Agreement for pre-clinical animal trials with WP Min to address FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=59372541
Oct 31, 2013 - Cook General Biotechnology to continue producing clinical grade HemaXellerate for pre-clinial and clinical studies.
http://ih.advfn.com/p.php?pid=nmona&article=59847939
Dec 11, 2013 - Update on WP Min work regarding pre-clinical animal studies
http://ih.advfn.com/p.php?pid=nmona&article=60352616
May 12, 2014 - FDA accepted the clinical protocol and the product manufacturing information; clarification on animal safety studies was requested.
http://ih.advfn.com/p.php?pid=nmona&article=62167863
Sept 10, 2014 - Regen to submit additional safety data from a GLP-certified lab prior to initiating clinical trials.
http://www.marketwired.com/press-release/regen-biopharma-provides-update-on-hemaxellerate-ind-progress-after-conference-call-otcbb-rgbp-1945965.htm
Oct 6, 2014 - Experimental protocol submitted to FDA regarding proposed pre-clinical experiments; follow-up from previous PR.
http://www.marketwired.com/press-release/regen-biopharma-submits-experimental-protocol-fda-hemaxellerate-aplastic-anemia-trial-otcbb-rgbp-1954889.htm
Oct 14, 2014 - Dr. Amit Patel Joins Scientific Advisory Board, has experience in over 17 FDA trials; will assist Regen with HemaXellerate and dCellVax.
http://www.marketwired.com/press-release/cell-therapy-expert-dr-amit-patel-joins-regen-biopharma-inc-scientific-advisory-board-otcbb-rgbp-1957807.htm
Jan 14, 2015 - Progress update for 2015; FDA is reviewing protocols for HemaXellerate GLP safety study.
http://www.marketwired.com/press-release/regen-biopharma-inc-provides-update-on-companys-progress-areas-specialization-2015-otcbb-rgbp-1982809.htm
Mar 17, 2015 - Regen received final comments and authorization from the FDA to proceed with the GLP safety study; clinical trial anticipated to begin once GLP data is reviewed by the FDA.
http://www.marketwired.com/press-release/regen-receives-green-light-from-fda-proceed-with-glp-safety-study-support-its-hemaxellerate-otcbb-rgbp-2001028.htm
Apr 7, 2015 - Thomas Ichim will present a poster entitled "HEMAXELLERATE I™, AUTOLOGOUS ADIPOSE STROMAL VASCULAR FRACTION CELLS, FOR SEVERE APLASTIC ANEMIA" at the 13th International Symposium on Myelodysplastic Syndromes. RGBP also has two other presentations scheduled for this symposium.
http://www.marketwired.com/press-release/regen-biopharma-inc-present-multiple-presentations-13th-international-symposium-on-myelodysplastic-otcbb-rgbp-2007259.htm
Apr 13, 2015 - Selection process of potential GLP labs (for HemaXellerate safety study) narrowed down to two candidates.
http://www.marketwired.com/press-release/regen-biopharma-narrows-selection-cro-candidates-hemaxellerate-glp-safety-studies-requested-2008917.htm
Apr 22, 2015 - Regen selects Charles River Laboratories to carry out the GLP safety study for HemaXellerate. Expected to be last phase of experimentation before clinical trials can begin.
http://www.marketwired.com/press-release/regen-biopharma-inc-engages-charles-river-laboratories-initiate-fda-requested-study-otcbb-rgbp-2012279.htm
Sept 25, 2015 - Regen receives audited draft report from Charles River showing no adverse effects in 10X dose of HemaXellerate in animal safety study. Expected 10-patient clinical trial forthcoming.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-announces-positive-results-from-glp-safety-study-for-hemaxellerate-529494211.html
Nov 17, 2015 - Regen submits response (including GLP preclinical toxicology data from CRL) to the FDA. Expecting FDA clearance to begin HemaXellerate clinical trial.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-submits-response-to-fda-questions-on-hemaxellerate-investigational-new-drug-application-550996231.html
** All dates listed above refer to the date of the linked PR **
$ RGBP $
What's the opposite of "TIMBER", and please yell that in addition every time someone hits the ask on this low volume/large spread day?
$ RGBP $
Fantastic find NEW! Setting up for another IND I'd guess.
$ RGBP $
SUMMARY OF HEMAXELLERATE PROGRESS (UPDATED SEPT 2015):
Jan 24, 2013 - Pre-clinical proof of concept and plan to file IND.
http://ih.advfn.com/p.php?pid=nmona&article=55986712
Feb 5, 2013 - Announcement that IND was filed.
http://ih.advfn.com/p.php?pid=nmona&article=56150687
Mar 18, 2013 - Regen receives IND# from FDA.
http://ih.advfn.com/p.php?pid=nmona&article=56788567
Apr 4, 2013 - FDA will send a letter outlining items which must be addressed prior to initiating clinical trials.
http://ih.advfn.com/p.php?pid=nmona&article=57035344
Jun 6, 2013 - Regen responds to FDA questions (including new data).
http://ih.advfn.com/p.php?pid=nmona&article=57897013
Jul 31, 2013 - Regen in second round of discussion with FDA on a new set of FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=58628844
Sept 26, 2013 - Agreement for pre-clinical animal trials with WP Min to address FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=59372541
Oct 31, 2013 - Cook General Biotechnology to continue producing clinical grade HemaXellerate for pre-clinial and clinical studies.
http://ih.advfn.com/p.php?pid=nmona&article=59847939
Dec 11, 2013 - Update on WP Min work regarding pre-clinical animal studies
http://ih.advfn.com/p.php?pid=nmona&article=60352616
May 12, 2014 - FDA accepted the clinical protocol and the product manufacturing information; clarification on animal safety studies was requested.
http://ih.advfn.com/p.php?pid=nmona&article=62167863
Sept 10, 2014 - Regen to submit additional safety data from a GLP-certified lab prior to initiating clinical trials.
http://www.marketwired.com/press-release/regen-biopharma-provides-update-on-hemaxellerate-ind-progress-after-conference-call-otcbb-rgbp-1945965.htm
Oct 6, 2014 - Experimental protocol submitted to FDA regarding proposed pre-clinical experiments; follow-up from previous PR.
http://www.marketwired.com/press-release/regen-biopharma-submits-experimental-protocol-fda-hemaxellerate-aplastic-anemia-trial-otcbb-rgbp-1954889.htm
Oct 14, 2014 - Dr. Amit Patel Joins Scientific Advisory Board, has experience in over 17 FDA trials; will assist Regen with HemaXellerate and dCellVax.
http://www.marketwired.com/press-release/cell-therapy-expert-dr-amit-patel-joins-regen-biopharma-inc-scientific-advisory-board-otcbb-rgbp-1957807.htm
Jan 14, 2015 - Progress update for 2015; FDA is reviewing protocols for HemaXellerate GLP safety study.
http://www.marketwired.com/press-release/regen-biopharma-inc-provides-update-on-companys-progress-areas-specialization-2015-otcbb-rgbp-1982809.htm
Mar 17, 2015 - Regen received final comments and authorization from the FDA to proceed with the GLP safety study; clinical trial anticipated to begin once GLP data is reviewed by the FDA.
http://www.marketwired.com/press-release/regen-receives-green-light-from-fda-proceed-with-glp-safety-study-support-its-hemaxellerate-otcbb-rgbp-2001028.htm
Apr 7, 2015 - Thomas Ichim will present a poster entitled "HEMAXELLERATE I™, AUTOLOGOUS ADIPOSE STROMAL VASCULAR FRACTION CELLS, FOR SEVERE APLASTIC ANEMIA" at the 13th International Symposium on Myelodysplastic Syndromes. RGBP also has two other presentations scheduled for this symposium.
http://www.marketwired.com/press-release/regen-biopharma-inc-present-multiple-presentations-13th-international-symposium-on-myelodysplastic-otcbb-rgbp-2007259.htm
Apr 13, 2015 - Selection process of potential GLP labs (for HemaXellerate safety study) narrowed down to two candidates.
http://www.marketwired.com/press-release/regen-biopharma-narrows-selection-cro-candidates-hemaxellerate-glp-safety-studies-requested-2008917.htm
Apr 22, 2015 - Regen selects Charles River Laboratories to carry out the GLP safety study for HemaXellerate. Expected to be last phase of experimentation before clinical trials can begin.
http://www.marketwired.com/press-release/regen-biopharma-inc-engages-charles-river-laboratories-initiate-fda-requested-study-otcbb-rgbp-2012279.htm
Sept 25, 2015 - Regen receives audited draft report from Charles River showing no adverse effects in 10X dose of HemaXellerate in animal safety study. Expected 10-patient clinical trial forthcoming.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-announces-positive-results-from-glp-safety-study-for-hemaxellerate-529494211.html
** All dates listed above refer to the date of the linked PR **
$ RGBP $
Yeah I've been slacking on that for the past few updates. I've been waiting for something big like this news item. If I have time later I'll post an updated version!
$ RGBP $
Great news here today! With the FDA having previously cleared the manufacturing and clinical protocols, the GLP-certified safety study was the last hurdle on the path to clinical trials. Looking forward to the FDA response this time!
$ RGBP $
Looking good today! September is a week away, hoping for some nice HemaXellerate news!
$ RGBP $
I'm pleased with today's update. Glad to know some kind of a timeframe has been posted about the GLP study. At this point, it's better that things are done carefully and correctly rather than rushed. This really seems like it will be that final hurdle, seeing them finally reach clinical trials would be quite the milestone.
Taking time away from the board has been useful for sitting through the lulls. Good luck to everyone here; looking forward to future developments!
Good job on the accurate prediction 3 months ago btw!
Cheers,
CT
Nice find!! Here's a link showing RGBP's license from Benitec:
5. CANCER VACCINES with Regen Biopharma
Status
In August 2013, Benitec granted a license to US based Regen BioPharma Inc. (Regen), a subsidiary of the Bio-Matrix Scientific Group, to use ddRNAi technology for the development of cancer vaccines.
Benitec's licence to Regen covers the application of ddRNAi to silence indoleamine 2,3 - dioxygenase (IDO) in dendritic cells. IDO is associated with immune-suppression and is over-expressed in cancer. Regen has produced pre-clinical evidence that modification of these cells using ddRNAi targeting the silencing of IDO should significantly enhance their efficacy as anti-cancer vaccine agents.
http://www.benitec.com/pipeline/licensed-programs-detail
Thanks for posting GM, this is great news for Christine Ichim's work with the retinoic acid and NR2F6. Hopefully that's progressing well enough to need expert input. And IND is certainly gonna come through down the road!
$ RGBP $
RGBP obtained the following IP for Ebola:
IP DESCRIPTION: Immune Modulation by TLR Activation for Treatment of Filovirus Infections Including Ebola
PATENT NUMBER: 62085636
APPLICATION DATE: 12/15/2014
PRIORITY DATE: 11/30/2014
http://regenbiopharma.com/intellectual-property.html
Nice post! Today's PR is also effectively an update about the progress of the dCellVax IND, which they stated they are responding to FDA questions. In my opinion, the IND process of dCellVax will be delayed (but for good reason); these added developments and IP will make it even more effective and worthy of clinical pursuit!
As you said, HemaXellerate GLP is making progress in the meantime, in addition to further in-house pursuits with their new lab space. The trading swings and gaps of RGBP have been irritating to follow recently, so I've decided to lay low and wait the few months for more developments to materialize before evaluating any kind of PPS or trends. Looking good though!
Cheers and GLTA!
$ RGBP $
Strange trading here recently, although I guess not entirely unexpected (historically) when things have been quiet otherwise. The low volume represents such a small minority of the total shares that this is inconsequential in the long run. We know that CRL is working on the safety study at the moment and we should hear about that sometime this summer*, along with any other progress on dCellVax or the NR2F6 work.
(* - I'm unsure of exactly how long is expected or necessary for the test, although I'd wager at least 3-6 months from start to finish)
$ RGBP $
Most will admit that Regen's (i.e., Koos') inexperience has definitely shown over the course of HemaXellerate's lifetime. Lucky for us, the FDA seems to be holding their hand through a lot of this. As far as I can tell, there is no "3 strikes and you're out" policy, so as long as Regen is willing to make the necessary corrections (even if that requires a bit of backtracking), it has a good chance of getting approval, even if it will be 2+ years at that point.
I also have to imagine this process has been quite the learning experience for them, and it's clear that the company is the most structured and capable it's ever been.
$ RGBP $
And let's keep in mind that HemaXellerate isn't some foreign compound introduced into the patient; it is custom developed from the endothelial cells of that exact patient's own fatty (adipose) tissue. While I'm certainly no expert, this process sounds safer than injecting some stock drug into the patient.
Bottom line - I'm fairly confident that the safety study is highly reproducible to what was seen already. Hoping to see an announcement of the safety study timeline and/or progress within the next couple weeks/months.
$ RGBP $
It was actually in my post, here you go:
Oral Presentation 2 Abstract: C.Ichim - NR2F6 (EAR-2) IS A NOVEL LEUKEMIA AND MDS ONCOGENE, OVER-EXPRESSED IN PATIENTS, THAT INHIBITS HEMATOPOIETIC DIFFERENTIATION AND BLOCKS ERYTHROPOIETIC DIFFERENTIATION AT THE PROERYTHROCYTE STAGE
OR07 Oral Session
MDS and the aging stem cell: Abstracts
01-May-2015 11:00 12:00
Expecting to see 10-Q by May 8th, 2015. Based on recent PR frequency, probably something early next week as well ahead of the 10-Q.
$ RGBP $
Today was Christine Ichim's presentation about the NR2F6 work, presented at the 13th International Symposium on Myelodysplastic Syndromes.
Oral Presentation 2 Abstract: C.Ichim - NR2F6 (EAR-2) IS A NOVEL LEUKEMIA AND MDS ONCOGENE, OVER-EXPRESSED IN PATIENTS, THAT INHIBITS HEMATOPOIETIC DIFFERENTIATION AND BLOCKS ERYTHROPOIETIC DIFFERENTIATION AT THE PROERYTHROCYTE STAGE
OR07 Oral Session
MDS and the aging stem cell: Abstracts
01-May-2015 11:00 12:00
Abstract:
NR2F6 (EAR-2) IS A NOVEL LEUKEMIA AND MDS ONCOGENE, OVER-EXPRESSED IN PATIENTS, THAT INHIBITS HEMATOPOIETIC DIFFERENTIATION AND BLOCKS ERYTHROPOIETIC DIFFERENTIATION AT THE PROERYTHROCYTE STAGE
The hierarchical organization of leukemia suggests that discovery of the genes that encode for maintenance of the undifferentiated state of leukemia stem cells will have important clinical relevance. Using a novel single-cell approach that gave unprecedented sample purity, we identified NR2F6 (EAR-2), as a gene associated with leukemia cells that retain the ability to divide. We validated that patients with leukemia and MDS expressed higher levels of NR2F6 mRNA than healthy bone marrow, and showed that silencing of NR2F6 induced differentiation and apoptosis of a human leukemia cell line. Here we studied the roles of NR2F6 in normal hematopoiesis and in the pathogenesis of MDS and acute myelogenous leukemia (AML).
In vitro, primary bone marrow cells engineered to overexpress NR2F6 undergo a block of differentiation, but have greatly extended proliferative ability in colony assays. Overexpression of NR2F6 profoundly impaired differentiation along multiple hematopoietic lineages including the erythroid lineage. NR2F6 over-expressing bone marrow cells formed 40% fewer BFU-E colonies, but had greatly extended replating capacity in colony assays. While knockdown of NR2F6 increased the number of cells produced per BFU-E colony 300%.
In vivo, overexpression of NR2F6 in a chimeric mouse model leads to a condition that resembles MDS with hypercellular bone marrow, increased blasts, abnormal localization of immature progenitors, morphological dysplasia of the erythroid lineage and a competitive advantage over wild-type cells, that eventually leads to AML in a subset of the mice.
Normal mice transplanted with bone marrow cells from the NR2F6 chimeric mice undergo an expansion of the stem cell compartment in the transplanted mice. This observation was confirmed ex vivo: overexpression of NR2F6 maintained hematopoietic stem cells in culture, while silencing of NR2F6 induces profound differentiation of hematopoietic stem cells. Transplanted animals also developed a rapidly fatal leukemia characterized by pancytopenia, enlargement of the spleen, and infiltration of blasts into the spleen, liver and peripheral blood. Leukemic cells had an erythroblastic morphology and immunophenotype. We further observed an increase of erythroblasts in the bone marrow of preleukemia animals cells, suggesting that over-expression of NR2F6 blocks erythroid differentiation at the erythroblast stage. Mechanistically, we show that DNA binding is necessary for NR2F6 function, and that NR2F6 functions in an HDAC-dependent manner, regulating expression genes involved in erythroid differentiation.
These data establish that NR2F6 is a novel oncogene that controls hematopoietic cell fate decisions and is an ideal target for differentiation therapy of acute leukemia and MDS.
Co-authors
C. Ichim1, D. Dervovic2, D. Koos1, T. Ichim1, R. Wells3.
1Molecular Therapeutics, Regen BioPharma Inc., San Diego, USA.
2Immunology, University of Toronto, Toronto, Canada.
3Department of Medical Oncology/Hematology Odette Cancer Center, University of Toronto and Sunnybrook Health Sciences Center, Toronto, Canada.
http://mds.kenes.com
REMINDER: This week RGBP will be at the 13th International Symposium on Myelodysplastic Syndromes held in Washington DC from April 29th - May 2nd, 2015.
Between Christine Ichim and Thomas Ichim there will be a total of three presentations:
(1) April 30th - C.Ichim - TECHNIQUE FOR ESTABLISHMENT OF LONG TERM IN VITRO CULTURES OF PRIMARY MDS CELLS (Oral Presentation)
(link to the abstract)
(2) April 30th - T.Ichim - HEMAXELLERATE I™, AUTOLOGOUS ADIPOSE STROMAL VASCULAR FRACTION CELLS, FOR SEVERE APLASTIC ANEMIA (Poster Presentation)
(link to the abstract)
(3) May 1st - C.Ichim - NR2F6 (EAR-2) IS A NOVEL LEUKEMIA AND MDS ONCOGENE, OVER-EXPRESSED IN PATIENTS, THAT INHIBITS HEMATOPOIETIC DIFFERENTIATION AND BLOCKS ERYTHROPOIETIC DIFFERENTIATION AT THE PROERYTHROCYTE STAGE (Oral Presentation)
(link to the abstract)
Link to the announcement PR (released April 7th, 2015): http://www.marketwired.com/press-release/regen-biopharma-inc-present-multiple-presentations-13th-international-symposium-on-myelodysplastic-otcbb-rgbp-2007259.htm
Symposium website: http://mds.kenes.com/
$ RGBP $
Great post CV, that's the proper way to digest these light PRs. My big takeaway was also the development milestones for the NR2F6 work, which sounds like it's further along than I was guessing last week. And as you said, we'll see if anything develops from the "interest" depending on how significant, and from what sources.
$ RGBP $
Nice post, Mando! Couldn't agree more
$ RGBP $
I think the "announcement of milestones" was not meant to be as cryptic as it was made out to be on the board. I think this information is already contained within the PR and the presentation abstract.
From the PR:
"Using this technique, researches showed that retinoic acid was able to activate the assay at supra-physiological concentrations, acting as a "hit". "The role of retinoids as agents of differentiation in embryology, stem cell biology and the maturation of blood cells has been well established. That retinoic acid can bind to our gene, albeit at super-physiological concentrations, is exciting because it validates our initial observation that our target gene functions to inhibit differentiation and to maintain cancer cells in a stem cell state. It validates the hypothesis that by turning off our gene using a small molecule like retinoic acid, we can target specifically the cancer stem cells to mature," said Dr. Christine Ichim."
http://www.marketwired.com/press-release/regen-biopharma-inc-announces-small-molecule-drug-discovery-milestones-american-association-otcbb-rgbp-2008056.htm
"Retinoic acid and its analogues have long been studied in the context of chemoprevention and differentiation therapy based on their anti-proliferative, pro-apoptotic, and ability to induce differentiation. We have now commenced the search for a high affinity small molecular inhibitor of NR2F6 activity by screening commercially available libraries that contain compounds with similar chemical structure to retinoic acid using the luciferase-based assay developed here."
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=d159ef6b-e47f-402a-9a14-1c3bbdff5bfb&cKey=711f053f-2ff6-4320-849c-62b885a1fb6f&mKey=%7b19573A54-AE8F-4E00-9C23-BD6D62268424%7d