header logo image


Page 53«..1020..52535455..»

Archive for the ‘Regenerative Medicine’ Category

Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for …

Thursday, June 14th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

Excerpt from:
Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for ...

Read More...

Biostem U.S., Corporation Engages Acropolis Agency to Assist in Implementing Its International Marketing Plan

Saturday, June 9th, 2012

CLEARWATER, FL--(Marketwire -06/08/12)- Biostem U.S., Corporation, (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, today reported that it has engaged Acropolis Inc. http://www.acropolisinc.com, a full-service advertising agency located in Orlando, Florida, to lend their expertise in brand building, marketing, and advertising development and placement.

Biostem Chief Executive Officer Dwight Brunoehler stated, "After several months of interviewing prospective agencies, we have come to the conclusion that Acropolis is the one to assist us in executing our plans. Their notable work in multiple media areas is impressive, to say the least. Their client list including The University of Florida, Arby's Restaurants, and the City of Orlando, speaks for itself."

Acropolis Principal, Scott Major, said, "This is a great fit for Acropolis. Our entire team loves the Biostem business approach in the incredible field of regenerative medicine. The hair re-growth field in which we will be marketing the Biostem technology is enormous. We are pleased to be a part of Biostem's expansion."

About Biostem U.S. CorporationBiostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S., Corporation is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

For further information, contact Fox Communications Group at 310-974-6821, or view the Biostem website at http://www.biostemus.com.

The rest is here:
Biostem U.S., Corporation Engages Acropolis Agency to Assist in Implementing Its International Marketing Plan

Read More...

Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in …

Thursday, June 7th, 2012

SAN DIEGO, CA--(Marketwire -06/06/12)-

Bio-Matrix Scientific Group (BMSN) (BMSN) announced today that its Regen BioPharma unit has appointed three internationally renowned regenerative medicine experts to its Scientific Advisory Board (SAB). The new SAB members appointed are David White, M.D., PhD; Wei-Ping Min, M.D., PhD and Vlad Bogin, M.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 PhD degrees from Cambridge University.

Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.

Dr. Bogin is the President and CEO of Cromos Pharma, a contract research organization that specializes in biopharmaceutical clinical outsourcing. He was formerly the Director of Boehringer Ingelheim in charge of the phase IV program for Dabigatran Etexilate. He studied at the Yale University School of Medicine and the University of Rochester School of Medicine and Dentistry.

Regen BioPharma has also entered into a Letter of Intent with Clinartis LLC, a global contract research organization (CRO). Clinartis is a full service global CRO serving pharmaceutical, biotech and medical device companies to support Phase I - IV drug and device clinical trials in the US and Europe.

The SAB and Clinartis will assist the Company in its acquisition of intellectual property related to stem cells, translation of the intellectual property into treatments, and optimizing the value of these new therapies.

"The potential of regenerative medicine products is significant," says Christopher Mizer, the President of Regen BioPharma. "We believe that strategic collaborative relationships between Regen BioPharma, our SAB and Clinartis will facilitate our efforts to create value from that potential by developing proprietary, life sciences technologies and demonstrating their clinical utility."

"Our strong SAB has scientific and regulatory expertise, coupled with Clinartis' access to world-class researchers and investigators will be very instrumental for accelerated commercialization of the cutting-edge biotechnology research on which Regen BioPharma is focused," according to Bio-Matrix Scientific Group's Chairman & CEO David Koos.

About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:

See the article here:
Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in ...

Read More...

AuxoCell Laboratories Licenses Umbilical Cord Tissue Stem Cell Service to Brazil’s CordVida

Thursday, June 7th, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Leading stem cell therapeutic and regenerative medicine company, AuxoCell Laboratories, Inc., today announced an agreement with CordVida, a Brazilian stem cell cryopreservation company, which will allow CordVida to expand its services. Families who select CordVida to store umbilical cord blood will now have the opportunity to bank stem cells from an additional source cord tissue. With this agreement, AuxoCell broadens its international reach to South America.

At AuxoCell, we are pleased by the opportunity to provide this groundbreaking technology to families around the globe, said Rouzbeh R. Taghizadeh, PhD, Chief Scientific Officer of AuxoCell Laboratories, Inc. CordVida is Brazils premier cord blood bank and adheres to the highest quality standards. It is for that reason that we have selected them as our exclusive partner in Brazil.

Cord tissue has an abundant source of mesenchymal stem cells (MSCs). Currently, there is a significant amount of research underway focused on mesenchymal stem cells extracted from cord tissue. MSCs are rapidly becoming the leading stem cell in regenerative medicine studies, and MSCs from a variety of sources are in use in over 150 clinical trials. The AuxoCell cord tissue technology represents the gold standard in the industry, as its technology prepares stem cells that are ready for immediate use, if needed.

CordVida is excited to be the first company in Brazil to offer storage of multiple kinds of stem cells, says Roberto Waddington, CEO for CordVida. Considering the enormous therapeutic prospects of cord tissue derived MSCs, our clients in the future will now rely on a much wider array of potential therapeutic applications.We are proud that AuxoCell selected CordVidaas its exclusive technology partner for all of Brazil.

Banking umbilical cord tissue stem cells offers clients a chance to reap the benefits of research that is being conducted on MSCs. Additionally, AuxoCells own studies have shown that a combination of cord tissue mesenchymal stem cells derived using AuxoCells validated processing SOPs and hematapoietic stem cells (HSCs) from the cord blood enhances the engraftment of the cord blood HSCs.

About AuxoCell

AuxoCell Laboratories, Inc. (AuxoCell) is a leading stem cell therapeutic and regenerative medicine company located in Massachusetts. AuxoCell's primary research focus is to develop the enormous therapeutic potential of the primitive stem cells found in the Wharton's Jelly of the human umbilical cord. With exclusive patent rights and proprietary processing protocols, AuxoCell is uniquely situated to offer the very best in cord tissue stem cell banking. Through strategic partnerships with both private and public cord blood banks, stem cell centers, and research laboratories around the world, AuxoCell strives every day to bring novel stem cell therapies from the bench to the bedside. Additional information is available through HYPERLINK http://www.auxocell.com or at (617) 610-9000.

About CordVida

Founded in 2004, CordVida is the premier stem cell cryopreservation company in Brazil with 10.000 umbilical cord blood units stored. It is the cord blood bank of choice for key doctors in Brazil. Committed to the highest global quality standards, CordVida has been AABB accredited since 2008. Half of the transplants made in Brazil using private cord blood units have been made with units stored in CordVida.

View post:
AuxoCell Laboratories Licenses Umbilical Cord Tissue Stem Cell Service to Brazil’s CordVida

Read More...

Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications

Saturday, June 2nd, 2012

CLEARWATER, FL--(Marketwire -06/01/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine science sector, has made its Scientific and Medical Board of Advisors publications available on the company website, http://www.biostemus.com.

Chief Executive Officer Dwight Brunoehler stated, "The company is very proud of the many contributions its SAMBA members have made, and continue to make, to the medical community. As their publications and credentials show, this is a very prestigious and influential group. Having worked with them in past projects and now at Biostem, I know them all to be active participants in the development and guidance of the company's objectives. Their diversified areas of expertise and backgrounds are already playing a major role in assisting the company as it moves forward into the expanding field of regenerative medicine."

About Biostem U.S., Corporation Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S., Corporation is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group 310-974-6821.

Excerpt from:
Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications

Read More...

Bioheart and Ageless Regenerative Partner to Advance Stem Cell Field With New Laboratory Training Program on June 23 …

Tuesday, May 29th, 2012

SUNRISE, Fla., May 29, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRT.OB - News) announced today that it will offer another laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine, on Saturday/Sunday June 23-24, 2012. Attendees will participate in hands on, in depth training in laboratory practices in stem cell science at Bioheart, Inc.'s corporate headquarters and clean room in Sunrise, Florida. The course was designed for Laboratory technicians, Students, Physicians and Physician Assistants.

"Attendees will graduate from this one-of-a-kind course with an extensive understanding of stem cell science laboratory practices," said Kristin Comella, Chief Scientific Officer, Bioheart, Inc. "Previous attendees described the course as incredibly well orchestrated providing comprehensive know how for laboratory start up."

An emerging field with tremendous opportunities, adult stem cell research has been shown to regenerate and repair injured or diseased structures via the release of bioactive tissue growth factors and cytokines. This is the second time that The Ageless Regenerative Institute has partnered with Bioheart, Inc. to provide hands-on training in a stem cell laboratory. This course provides instruction regarding how to grow stem cells and perform quality control testing in an actual cGMP facility following FDA regulations.

The course goals and objectives include reviewing stem cell types and characteristics; learning cell culture including plating, trypsinization and harvesting, and cryopreservation; learning quality control tests including cell count, viability, flow cytometry, endotoxin, mycoplasma, sterility; and learning and performing cGMP functions including clean room maintenance, gowning and environmental monitoring.

For information on costs and to register, visit http://www.agelessregen.com or email: info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Excerpt from:
Bioheart and Ageless Regenerative Partner to Advance Stem Cell Field With New Laboratory Training Program on June 23 ...

Read More...

Biostem U.S., Corporation Appoints Philip A. Lowry, MD as Chairman of Its Scientific and Medical Board of Advisors

Tuesday, May 29th, 2012

CLEARWATER, FL--(Marketwire -05/29/12)- Biostem U.S., Corporation, (HAIR.PK) (HAIR.PK) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, today announced that Philip A. Lowry, MD, has been appointed as the Chairman of its Scientific and Medical Board of Advisors (SAMBA).

According to Biostem CEO, Dwight Brunoehler, "As Chairman, Dr. Lowry will work with a team drawn from a cross-section of medical specialties. His combination of research, academic and community practice experience make him the perfect individual to coordinate and lead the outstanding group of physicians that makes up our SAMBA. As a group, The SAMBA will guide the company to maintain the highest ethical standards in every effort, while seeking and developing new cutting edge technology based on stem cell use. I am privileged to work with Dr. Lowry, once again."

Dr. Lowry stated, "Dwight is an innovative businessman with an eye on cutting-edge stem cell technology. His history in the industry speaks for itself. I like the plan at Biostem and look forward to working with everyone involved."

Dr. Philip A. Lowry received his undergraduate degree from Harvard College before going on to the Yale University School of Medicine. His completed his internal medicine residency at the University of Virginia then pursued fellowship training in hematology and oncology there as well. During fellowship training and subsequently at the University of Massachusetts, he worked in the laboratory of Dr. Peter Quesenberry working on in vitro and in vivo studies of mouse and human stem cell biology.

Dr. Lowry twice served on the faculty at the University of Massachusetts Medical Center from 1992-1996 and from 2004-2009 as an assistant and then associate clinical professor of medicine establishing the bone marrow/stem cell transplantation program there, serving as medical director of the Cryopreservation Lab supporting the transplant program, helping to develop a cord blood banking program, and teaching and coordinating the second year medical school course in hematology and oncology. Dr. Lowry additionally has ten years experience in the community practice of hematology and oncology. In 2010, Dr. Lowry became chief of hematology/oncology for the Guthrie Health System, a three-hospital tertiary care system serving northern Pennsylvania and southern New York State. He is charged with developing a cutting-edge cancer program that can project into a traditionally rural health care delivery system.

Dr. Lowry has also maintained a career-long interest in regenerative medicine springing from his research and practice experience in stem cell biology. His new role positions him to foster further development of that field. As part of a horizontally and vertically integrated multi-specialty team, he is closely allied with colleagues in cardiology, neurology/neurosurgery, and orthopedics among others with whom he hopes to stimulate the expansion of regenerative techniques.

About Biostem U.S., Corporation

Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell-related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group 310-974-6821.

Go here to see the original:
Biostem U.S., Corporation Appoints Philip A. Lowry, MD as Chairman of Its Scientific and Medical Board of Advisors

Read More...

Industry-sponsored cardiovascular cell therapies. Some metrics.

Sunday, May 27th, 2012

Tweet


Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.


The data to-date are admittedly confusing.  From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.


Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc. 


All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not.  We will not attempt to do so.


All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions.  So here it is:


Commercial:
Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication.  Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI).  The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.


Phase III or II/III:
There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials.  Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.

  • Baxter Therapeutics' Auto-CD34+ cells
  • Cytori
Two companies warrant particular mention at this stage as they appear to be in transition between phases II and III.

Cardio3 Biosciences initially designed a trial of their autologous C-Cure in heart failure secondary to ischemic cardiomyopathy to be a phase II/III trial enrolling 240 patients.  While the trial began in late 2008 and is still registered as active but no longer recruiting on ClinicalTrials.gov the entry has not been updated for almost a year.  

In 2010 the company announced that after enrolling 45 patients - of which 21 were in the treatment arm (24 in the control arm) - they decided to close the study to future enrollment and prepare for a phase III trial.  This decision was reportedly based on "very encouraging data". 

Dr. Christian Homsy, CEO of Cardio3 BioSciences provided the following guidance: “The highly promising data we report today build on the favourable safety profile we have observed through this Phase II trial and documents in patients our belief that we have with  C-Cure a product candidate with the potential to make a real difference in the treatment of heart failure... As noted in the company’s press release of 29 June 2010, with the Phase II stage completed and to allow for potential modifications to the trial protocol, Cardio3 BioSciences has not proceeded to Phase III recruitment into the trial but has continued to gather all data for the six month analysis. Through the Phase II trial, we gained significant  experience in working with a highly innovative stem cell therapy in a clinical setting, and we are using this acquired knowledge in the design of our planned Phase III programme."  The phase III trial of C-Cure is expected to commence in the second half of 2012.

Mesoblast has also announced with its strategic partner, Teva, that they are proceeding with plans to conduct a phase III study of its allogeneic cell therapy product, Revascor, in chronic heart failure.  Most anticipate this clinical trial application to be filed sometime in late 2012.


Phase I or II:
There are over 20 active, industry-sponsored earlier-stage trials (phase I, I/II or II) for cardiovascular-related conditions.  At least 5 of these are expected to have clinical readouts this year.   



Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  
























































http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

Industry-sponsored cardiovascular cell therapies. Some metrics.

Sunday, May 27th, 2012

Tweet


Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.


The data to-date are admittedly confusing.  From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.


Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc. 


All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not.  We will not attempt to do so.


All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions.  So here it is:


Commercial:
Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication.  Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI).  The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.


Phase III or II/III:
There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials.  Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.

  • Baxter Therapeutics' Auto-CD34+ cells
  • Cytori
Two companies warrant particular mention at this stage as they appear to be in transition between phases II and III.

Cardio3 Biosciences initially designed a trial of their autologous C-Cure in heart failure secondary to ischemic cardiomyopathy to be a phase II/III trial enrolling 240 patients.  While the trial began in late 2008 and is still registered as active but no longer recruiting on ClinicalTrials.gov the entry has not been updated for almost a year.  

In 2010 the company announced that after enrolling 45 patients - of which 21 were in the treatment arm (24 in the control arm) - they decided to close the study to future enrollment and prepare for a phase III trial.  This decision was reportedly based on "very encouraging data". 

Dr. Christian Homsy, CEO of Cardio3 BioSciences provided the following guidance: “The highly promising data we report today build on the favourable safety profile we have observed through this Phase II trial and documents in patients our belief that we have with  C-Cure a product candidate with the potential to make a real difference in the treatment of heart failure... As noted in the company’s press release of 29 June 2010, with the Phase II stage completed and to allow for potential modifications to the trial protocol, Cardio3 BioSciences has not proceeded to Phase III recruitment into the trial but has continued to gather all data for the six month analysis. Through the Phase II trial, we gained significant  experience in working with a highly innovative stem cell therapy in a clinical setting, and we are using this acquired knowledge in the design of our planned Phase III programme."  The phase III trial of C-Cure is expected to commence in the second half of 2012.

Mesoblast has also announced with its strategic partner, Teva, that they are proceeding with plans to conduct a phase III study of its allogeneic cell therapy product, Revascor, in chronic heart failure.  Most anticipate this clinical trial application to be filed sometime in late 2012.


Phase I or II:
There are over 20 active, industry-sponsored earlier-stage trials (phase I, I/II or II) for cardiovascular-related conditions.  At least 5 of these are expected to have clinical readouts this year.   



Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  
























































http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

State awards stem cell grants to medical researchers

Friday, May 25th, 2012

SACRAMENTO California's stem cell agency today approved two grants to UC Davis Health System researchers for their innovative work in regenerative medicine.

Kyriacos A. Athanasiou, distinguished professor of orthopaedic surgery and professor and chair of biomedical engineering, and the Child Family Professor of Engineering at UC Davis, is investigating the use of skin-derived stem cells to heal cartilage injuries and debilitating conditions of the knee such as osteoarthritis.

W. Douglas Boyd, professor of surgery, plans to further refine a novel approach to treating cardiovascular injuries suffered during a heart attack by using stem cells and a tissue-like scaffold to repair cardiac damage.

The pair received individual grants totaling approximately $6.6 million from the California Institute for Regenerative Medicine's (CIRM) governing board.

Athanasiou's and Boyd's multi-year grants were among the proposals submitted to CIRM for its third round of Early Translational Awards, which are intended to enable clinical therapies to be developed more rapidly.

"Both of these scientists are conducting exciting research that could have far-reaching implications in health care," said Jan Nolta, director of the UC Davis Institute for Regenerative Cures and the university's stem cell program director. "Dr. Athanasiou is bioengineering new cartilage that could have the same physiological integrity as the cartilage a person is born with. Dr. Boyd is developing a treatment that uses a paper-thin patch embedded with stem cells to harness their regenerative powers to repair damaged heart muscle."

Boyd, who's a pioneering cardiothoracic surgeon, pointed out in his CIRM proposal that heart disease is the nation's number-one cause of death and disability. An estimated 16.3 million Americans over the age of 20 suffer from coronary heart disease, which in 2007 accounted for an estimated 1 in 6 deaths in the U.S. Boyd plans to use bone-marrow derived stem cells -- known as mesenchymal stem cells -- in combination with a bioengineered framework known as an extracellular matrix, to regenerate damaged heart tissue, block heart disease and restore cardiac function, something currently not possible except in cases of a complete and very invasive heart transplant.

An expert in biomedical engineering, Athanasiou is focusing on developing a cellular therapy using stem cells created from an individual's own skin -- known as autologous skin-derived stem cells -- which have shown great promise in animal models. He plans to use the new funding to conduct extensive toxicology and durability tests to determine the technique's long-term safety and efficacy. Such tests are among the many steps needed to advance toward human clinical trials.

Cartilage is the slippery tissue that covers the ends of bones in joints, allowing bones to glide over each other and absorbing the shock of movement. Cartilage defects from injuries and lifelong wear and tear can eventually degenerate into osteoarthritis. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, osteoarthritis is the most common form of arthritis and affects an estimated 27 million Americans over the age of 25.

"For anyone suffering from osteoarthritis or other debilitating cartilage conditions, Dr. Athanasiou's goal of using stem cells to regenerate new tissue could have enormous quality-of-life and economic benefits," said Nolta, who is the recipient of a prior translational grant from CIRM to develop potential therapies for Huntington's disease . "Dr. Boyd's work is equally promising because he's using a bioengineered structure to encourage cardiac tissue repair, which could have important benefits in the treatment of heart disease."

Follow this link:
State awards stem cell grants to medical researchers

Read More...

Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London

Wednesday, May 23rd, 2012

ROCKVILLE, Md., May 21, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that Richard Garr, CEO and President, will present at the World Stem Cells & Regenerative Medicine Congress in London (http://www.terrapinn.com/2012/stemcells/index.stm) on Tuesday, May 22nd at 12:30 PM. Mr. Garr's presentation, "Stem Cell Applications for Neurodegenerative Disorders," will review Neuralstem's cellular therapy trial in ALS, its neurogenic small molecule trial in major depressive disorder (MDD), and provide an overview on plans to expand the cellular therapy program.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.

For more information, please visit http://www.neuralstem.com or connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2011 and the Form 10-Q for the period ended March 30, 2012.

See original here:
Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London

Read More...

IntelliCell BioSciences Announces Collaborative Agreement with the University of Florida on Stem Cell and Tissue …

Wednesday, May 23rd, 2012

NEW YORK, May 22, 2012 /PRNewswire/ --IntelliCell BioSciences, Inc.("Company") (SVFC.PK) announced today that it has entered a sponsored research agreement with the Institute for Cell Engineering and Regenerative Medicine (ICERM) at the University of Florida. A portion of the collaborative work will be to explore the physiological characteristics of the adult autologous vascular cells that are also referred to as stromal vascular fraction cells which form the basis of the IntelliCell product. The company also intends to explore combination therapies with patent pending bio-engineered products under development. The Company believes that the IntelliCell product is an efficient cellular delivery platform for a variety of therapeutic applications and will look to partner with technology developers.

Said Jon Dobson, Ph.D., Professor of biomedical engineering and biomaterials at the University of Florida, "We are pleased to be working with IntelliCell. Their technology is innovative and appears to hold promise for future regenerative medicine applications. The use of adult autologous (your own) stem cells to repair and regenerate tissues are of great interest to personalized medicine researchers." Professor Dobson is a leading researcher in bionanotechnology and nanomedicine applications and apart from regenerative medicine, his work also spans across fields as diverse as gene therapy, stem cell therapy and tumor targeting. He is also the Director of the newly formed Institute for Cell Engineering and Regenerative Medicine at the University of Florida.

Dr. Steven Victor, CEO of IntelliCell, added "This is a very exciting time for regenerative medicine companies. We are looking forward to long and productive research collaboration with the University of Florida and Professor Dobson. IntelliCell believes that important contributions for better medicine will result from research collaborations with our university research colleagues." Robert Sexauer, Executive Vice President, ICBS Research, stated that "we would like to take a thought leadership position by working closely with those at the vanguard of regenerative medicine development."

About IntelliCell BioSciences

IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using adult autologous vascular cells (SVC's) derived from the blood vessels in the adult adipose tissue. IntelliCell Biosciences has developed its own patent pending protocol to separate adult autologous vascular cells from adipose tissue without the use of enzymes. IntelliCell will also be seeking to develop technology licensing agreements with technology developers, universities, and international business entities.

About University of Florida

The University of Florida is one of the nation's largest public universities. A member of the Association of American Universities, UF receives more than $619 million annually in sponsored research funding. Through its research and other activities, UF contributes more than $8.76 billion a year to Florida's economy and has a total employment impact of more than 100,000 jobs statewide. http://www.ufl.edu.University of Florida Research: Working for Florida.

Forward-LookingStatements

Certain statements set forth in this press release constitute "forward-looking statements." Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning," "expect," "believe," "will likely," "should," "could," "would," "may" or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company's actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company's ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company's limited operating history, the limited financial resources, domestic or global economic conditions, activities of competitors and the presence of new or additional competition, and changes in Federal or State laws. More information about the potential factors that could affect the Company's business and financial results is included in the Company's filings, available via the United States Securities and Exchange Commission.

Contacts:

Read more:
IntelliCell BioSciences Announces Collaborative Agreement with the University of Florida on Stem Cell and Tissue ...

Read More...

UTHealth Pediatric Surgery Expands Regenerative Medicine Program

Wednesday, May 23rd, 2012

Newswise About 3 percent of the babies born in the United States have a birth defect. Children without a birth defect are also susceptible to injury or disease. At The University of Texas Health Science Center at Houston (UTHealth), regenerative medicine researchers are exploring innovative ways to treat these conditions.

The Department of Pediatric Surgery at the UTHealth Medical School operates a research program devoted to childhood conditions that is seeking to harness the bodys regenerative powers to repair malformed organs and to mitigate injury from illness or trauma. It is called the Childrens Regenerative Medicine Program.

Kevin Lally, M.D., chairman of the Department of Pediatric Surgery at the UTHealth Medical School and surgeon-in-chief at Children's Memorial Hermann Hospital, announced the recruitment of four stem cell scientists to the program. The researchers are associate professor Yong Li, M.D., Ph.D., and assistant professors Scott Olson, Ph.D., Fabio Triolo, M.Phil., D.d.R., Ph.D., and Pamela Wenzel, Ph.D.

We were able to recruit outstanding investigators thanks in part to the generous support of Mrs. Clare Glassell and Mrs. Evelyn Griffin, said Lally, who is the A.G. McNeese Chair in Pediatric Surgery and the Richard Andrassy, M.D., Endowed Distinguished Professor at UTHealth. Our program in regenerative medicine is committed to a collaborative environment in which clinicians work with basic researchers.

Lally has a special interest in the treatment of a potentially life-threatening condition known as congenital diaphragmatic hernia that occurs in as many as one in every 2,500 live births and is often treated surgically. The diaphragm is a muscle separating the chest cavity and belly and is important for breathing.

The core fundamental problem is infants born with structural problems that need to be repaired, said Lally, who believes doctors may be able to use stem cells to replace the diaphragm or repair defects in the abdominal wall.

Stem cells may also help children with traumatic brain injuries. Charles Cox Jr., M.D., professor of pediatric surgery, director of the Pediatric Trauma Program at the UTHealth Medical School/Childrens Memorial Hermann Hospital and The Childrens Fund Inc. Distinguished Professor in Pediatric Surgery, is leading clinical research on the use of these versatile cells to address this leading cause of death and lifelong disability among children.

Yong Li, M.D., Ph.D.

Li previously served as a tenure track assistant professor in the Stem Cell Research Center at Childrens Hospital of Pittsburgh, where his laboratory studied the regenerative power of newts and salamanders in the hope of applying this information to the care of people.

Newts are able to regenerate missing body parts including limbs, spine and heart. Li has studied growth factors that facilitate this regeneration process in some amphibians and how they could be used for stem cell population and tissue engineering.

Read more:
UTHealth Pediatric Surgery Expands Regenerative Medicine Program

Read More...

Cell-based Cancer Immunotherapies. Some metrics..

Sunday, May 20th, 2012

Tweet 


Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.



One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

Some Segment Metrics
As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:
Commercial:
  • Dendreon's Provenge
    • Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
    • Efficacy: prolongs survival
    • Markets: only the United States (approved April 2010)
    • Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
    • 2011 Revenue $290,000
    • Projected 2012 Revenue: ~$380,000

Phase III or II/III:

Phase II or I/II

  • 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
    • ~10 of these are expected to have readouts yet this year
    • Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
    • Expected enrollment of 3,500+
Investment:

The following are notable cash infusions into the sector for 2012 to-date:
  • Bellicum Pharmaceuticals.  $20M series B. 
  • CellMedica. $15M grant from CPRIT in Texas.
  • Argos Therapeutcs. $25M Series D.
  • Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  












http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

Cell-based Cancer Immunotherapies. Some metrics..

Sunday, May 20th, 2012

Tweet 


Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.



One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

Some Segment Metrics
As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:
Commercial:
  • Dendreon's Provenge
    • Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
    • Efficacy: prolongs survival
    • Markets: only the United States (approved April 2010)
    • Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
    • 2011 Revenue $290,000
    • Projected 2012 Revenue: ~$380,000

Phase III or II/III:

Phase II or I/II

  • 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
    • ~10 of these are expected to have readouts yet this year
    • Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
    • Expected enrollment of 3,500+
Investment:

The following are notable cash infusions into the sector for 2012 to-date:
  • Bellicum Pharmaceuticals.  $20M series B. 
  • CellMedica. $15M grant from CPRIT in Texas.
  • Argos Therapeutcs. $25M Series D.
  • Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  












http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Sunday, May 20th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.

Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD).

ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

About SMD, Dry AMD and Degenerative Diseases of the Retina

Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.

Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the dry form of AMD which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

See the original post here:
Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Read More...

Regenerative medicine company begins enrollment in critical limb ischemia trial

Thursday, May 17th, 2012

Regenerative medicine startup Juventas Therapeutics has begun enrollment in a phase 2a trial of critical limb ischemia patients.

The Cleveland-based company, which recently secured an important investment from Takeda Pharmaceuticals, is planning to enroll 48 patients and complete enrollment early next year, CEO Rahul Aras said.

Juventas technology, called JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

Critical limb ischemia (CLI) patients are enrolling at several U.S. hospitals, as well as three in India. CLI is a severe obstruction of the arteries that greatly decreases blood flow to the extremities.

Advertisement

CLI has become a very exciting clinical opportunity, Aras said. Its becoming a growing area of interest for a number of biotech and pharma companies.

Other companies pursuing CLI treatment include Aastrom Biosciences, Arteriocyte and Biomet.

Among the top advantages of Juventas CLI therapy is its simplicity and cost-effectiveness, Aras said. Patients can be injected with the companys therapeutic in an easy procedure at a physician office, and the approach doesnt require bone marrow aspiration to obtain patients own stem cells or complex cell processing as some competing therapeutics do.

Juventas also has a phase 2 trial underway to investigate its therapy with heart failure patients.

The company is expected to shortly announce a series B round of investment, which includes the funding from Takeda, that totals around $20 million or $25 million.

See the original post:
Regenerative medicine company begins enrollment in critical limb ischemia trial

Read More...

New Teva Representative Joins Mesoblast Board of Directors

Friday, May 11th, 2012

MELBOURNE, Australia, May 10, 2012 /PRNewswire/ -- Global regenerative medicine company Mesoblast Limited (MSB.AX) today announced the appointment of Dr Ben-Zion Weiner, Special Adviser to the CEO of Teva Pharmaceutical Industries Ltd, as a non-executive Director of Mesoblast, effective immediately.

Dr Weiner has been Teva's head of global research and development for over three decades, most recently as Chief R&D Officer and a member of the Teva Executive Committee. In this role, he has directly overseen all pharmaceutical R&D and innovative branded product pipeline development.

Dr Weiner has been responsible for the development of hundreds of generic products for the US, EU and other markets. In parallel, he has been responsible for the development and regulatory approval of Teva's innovative product portfolio. Dr Weiner has twice been the recipient of the Rothschild prize for innovation, including for the commercialization of Copaxone in the treatment of multiple sclerosis.

Dr Weiner said: "I am happy and proud to be a Board member of Mesoblast. I trust that stem cell technology is the future of medicine, and that Mesoblast is at the cutting edge of this exciting new field.

"I believe that Mesoblast's unique technology and professional execution capabilities have the potential to deliver multiple innovative biologic products across a broad range of clinical indications," added Dr Weiner.

Mesoblast Chairman, Mr Brian Jamieson, said: "Dr Weiner's extensive pharmaceutical industry experience and his current role as Special Adviser to the Teva CEO make him a very valuable and strategic addition to the Board. We also acknowledge the important contributions and insights provided by Teva's retiring board representative, Kevin Buchi, and wish him well.

"As Mesoblast expands its clinical product portfolio and approaches product commercialization, we will continue to broaden the mix of skills and international expertise of our Directors to ensure that the Board is in the best position to deliver maximal shareholder value."

About Mesoblast Mesoblast Limited (MSB.AX) is a world leader in commercialising biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). http://www.mesoblast.com

For further information, please contact: Julie Meldrum Corporate Communications Mesoblast Limited E: julie.meldrum@mesoblast.com

View original post here:
New Teva Representative Joins Mesoblast Board of Directors

Read More...

Regenerative medicine: Could the ways animals regenerate hair and feathers help restore human fingers and toes?

Friday, May 11th, 2012

ScienceDaily (May 10, 2012) This summer's action film, "The Amazing Spider-Man," is another match-up between the superhero and his nemesis the Lizard. Moviegoers and comic book fans alike will recall that the villain, AKA Dr. Curt Connors, was a surgeon who, after losing an arm, experimented with cell generation and reptilian DNA and was eventually able to grow back his missing limb.

The latest issue of the journal Physiology contains a review article that looks at possible routes that unlock cellular regeneration in general, and the principles by which hair and feathers regenerate themselves in particular.

The authors apply what is currently known about regenerative biology to the emerging field of regenerative medicine, which is being transformed from fantasy to reality.

Review Article

While the concept of regenerative medicine is relatively new, animals are well known to remake their hair and feathers regularly by normal regenerative physiological processes. In their review, the authors focus on (1) how extrafollicular environments can regulate hair and feather stem cell activities and (2) how different configurations of stem cells can shape organ forms in different body regions to fulfill changing physiological needs.

The review outlines previous research on the role of normal regeneration of hair and feathers throughout the lifespan of various birds and mammals. The researchers include what is currently known about the mechanism behind this re-growth, as well as what gaps still exist in the knowledge base and remain ripe for future research.

The review examines dozens of papers on normal "physiological regeneration" -- the re-growth that happens over the course of an animal's life and not in response to an injury. This regeneration takes place to accommodate different stages in an animal's life (e.g., replacing downy chick feathers with an adult chicken's, or replacing the fine facial hair of a young boy with the budding beard of an adolescent), or in response to various environmental conditions (e.g., cats shedding a thick winter coat in the summer heat but re-growing it when the seasons change again, or snowshoe hares switching from brown in the summer to white in the winter for camouflage).

These changes seem to respond both to internal cues such as physiology of the hair follicle itself, or external cues such as the environment, but the mechanisms behind these normal alterations are largely unknown. Stem cells inside the follicle prompt hair and feather regeneration, but researchers are still unsure how to guide those cells to form the shape, size, and orientation of these "skin appendages" so that controlled re-growth is possible. Additionally, scientists are still unsure how to re-grow hair on skin in people after severe injuries that lead to scar tissue.

Importance of the Findings

The reviewed studies suggest that while researchers are making headway in understanding how and why hair and feathers regenerate after normal loss or in response to different life stages, much still remains unknown. This missing knowledge could hold valuable clues to learning how to regenerate much more complicated and valuable structures after loss to injury, such as fingers and toes.

Read more from the original source:
Regenerative medicine: Could the ways animals regenerate hair and feathers help restore human fingers and toes?

Read More...

Another > $100M month for companies in the cell therapy space

Sunday, May 6th, 2012

Tweet 


Last month we reported here on this blog that March was more than a $100M month for companies in the stem cell and cell-based regenerative medicine space in terms of monies raised.  

What we missed was a $15M grant from Cancer Prevention and Research Institute of Texas (CPRIT) for UK-based CellMedica.  This pumps last month's total to just under $140M.

This month, according to our sources, betters even March's better numbers by coming in at just over $170M though that is largely on the back of one large deal in Asia.  Here's how the numbers break down.

Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S.  Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.  


Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant.  The application to proceed with this trial is currently under review by Health Canada.


Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".  


The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR.  We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that.  We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.


The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.


Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3.  The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.


Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture.  This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.


ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones. 


Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula.  This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.


..


So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.  


Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.


--Lee


p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.


http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

Page 53«..1020..52535455..»


2024 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick