Acquisition of Intellectual Property and Data Leads to Expansion of Medistem Therapeutic Pipeline
SAN DIEGO, CA, Mar 07, 2012 (MARKETWIRE via COMTEX) — Medistem Inc. (pinksheets:MEDS) and Yale University have signed an exclusive worldwide licensing agreement covering the generation of pancreatic islets from stem cells such as the Endometrial Regenerative Cell (ERC). These pancreatic islets have effectively treated diabetes in animal models.
Professor Hugh Taylor of Yale University, inventor of the technology, made international headlines in September 2011 when he published his findings in the peer-reviewed journal Molecular Therapy.
“Medistem is the first company to develop clinical-grade endometrial-derived stem cells and initiate trials in humans,” said Professor Taylor. “Since Medistem’s Endometrial Regenerative Cells are manufactured inexpensively, can be used as an ‘off the shelf’ product, and to date appear safe in human subjects, I am very excited to see diabetes added to the list of diseases that can potentially be treated with Medistem’s ERCs.”
Medistem is currently in two clinical trials with ERCs: One for critical limb ischemia and a second for congestive heart failure, both of which are complications of uncontrolled diabetes.
“Type 1 diabetes is a rapidly growing poorly-served market. There is great optimism that cell-based therapies can address not only pancreatic degeneration but also the underlying immunological causes,” said Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, the largest non-profit organization focused on development of new therapeutic approaches for this disease. “The ERC is the newest adult stem cell to enter clinical trials. Based on this unique source of cells, as well as their immune modulatory properties, we believe this work may be expanded into other autoimmune diseases.”
About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company’s lead product, the endometrial regenerative cell (ERC), is a “universal donor” stem cell being developed for critical limb ischemia and congestive heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf . ERC can be purchased for scientific use through Medistem’s collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells .
Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.
Monday, March 12, 2012
Wednesday, March 7, 2012
Medistem Inc. to Add Kidney and Lung Failure to Clinical Trials of Endometrial Regenerative Cells (ERC) Stem Cells in Russia
SAN DIEGO, CA and PORTLAND, OR, Mar 05, 2012 (MARKETWIRE via COMTEX) -- Medistem Inc. (pinksheets:MEDS), in partnership with its Russian licensee, ERCell, announced the signing of a letter of intent* to begin clinical trials using Medistem's Endometrial Regenerative Cells (ERC) stem cells for renal, lung and peripheral artery disease. Trials will be conducted in the S.M. Kirov Military Medical Academy in St. Petersburg, Russia. Under the agreement, Medistem, ERCell and the Academy will work together to a) Design and obtain approval for clinical trials; b) Provide training and execute the trials; and c) Identify opportunities for commercialization of the ERC product through existing military and governmental programs.
Under the license agreement, Medistem receives cash and royalty revenues from Russian developmental activities as well as all the data gathered from the trials. According to the agreement, work performed by ERCell will be conducted according to international "Good Clinical Practices" (GCP) so the data gathered can be used for Russian registration as well as to support US FDA submissions.
"At Medistem, our philosophy has always been to follow the data. We aim to be as aggressive as possible, to obtain as much data as possible, as quickly as possible," stated Thomas Ichim, CEO of Medistem. "We are especially optimistic about the possibility of obtaining human data in renal failure patients, something that we otherwise would not have pursued at this stage if it weren't for the support of the S.M. Kirov Military Medical Academy."
"As the Medistem licensee for Russia and CIS (Commonwealth of Independent States), ERCell is committed to advancing our programs using as many non-dilutive means as possible," said Tereza Ustimova, CEO of ERCell. "By partnering with the best institutes in the country, we are committed to making ERCell Russia's premiere universal donor adult stem cell company."
S.M. Kirov Military Medical Academy conducts research in the following areas: metabolic derangements of cardiovascular pathology, nanotechnologies in biology and medicine, stem cells as a basis for the treatment of internal organs and blood diseases, blood circulation, vegetative nervous system and high-tech methods of diagnosis and treatment.
"We are highly impressed by the fact that the Endometrial Regenerative Cell (ERC) is the newest stem cell product to enter clinical trials. By the higher growth factor production ability compared to other types of stem cells, we are very eager to begin clinical trials," said Oleg Nagobovich, M.D., Chief of the Research Center, S.M. Kirov Medical Military Academy. "We feel our work will complement the ongoing work at the Backulev Center addressing heart failure by Medistem/ERCell."
*Letter of intent issued by Ministry of Defense, dated 2/24/12, No. 411A/119
About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf . ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells .
Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.
Contact:
Thomas Ichim
Chief Executive Officer
Medistem Inc.
9255 Towne Centre Drive, Suite 450
San Diego, CA 92122
858 349 3617
858 642 0027
www.medisteminc.com twitter: @thomasichim
SOURCE: Medistem Inc.
Under the license agreement, Medistem receives cash and royalty revenues from Russian developmental activities as well as all the data gathered from the trials. According to the agreement, work performed by ERCell will be conducted according to international "Good Clinical Practices" (GCP) so the data gathered can be used for Russian registration as well as to support US FDA submissions.
"At Medistem, our philosophy has always been to follow the data. We aim to be as aggressive as possible, to obtain as much data as possible, as quickly as possible," stated Thomas Ichim, CEO of Medistem. "We are especially optimistic about the possibility of obtaining human data in renal failure patients, something that we otherwise would not have pursued at this stage if it weren't for the support of the S.M. Kirov Military Medical Academy."
"As the Medistem licensee for Russia and CIS (Commonwealth of Independent States), ERCell is committed to advancing our programs using as many non-dilutive means as possible," said Tereza Ustimova, CEO of ERCell. "By partnering with the best institutes in the country, we are committed to making ERCell Russia's premiere universal donor adult stem cell company."
S.M. Kirov Military Medical Academy conducts research in the following areas: metabolic derangements of cardiovascular pathology, nanotechnologies in biology and medicine, stem cells as a basis for the treatment of internal organs and blood diseases, blood circulation, vegetative nervous system and high-tech methods of diagnosis and treatment.
"We are highly impressed by the fact that the Endometrial Regenerative Cell (ERC) is the newest stem cell product to enter clinical trials. By the higher growth factor production ability compared to other types of stem cells, we are very eager to begin clinical trials," said Oleg Nagobovich, M.D., Chief of the Research Center, S.M. Kirov Medical Military Academy. "We feel our work will complement the ongoing work at the Backulev Center addressing heart failure by Medistem/ERCell."
*Letter of intent issued by Ministry of Defense, dated 2/24/12, No. 411A/119
About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf . ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells .
Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.
Contact:
Thomas Ichim
Chief Executive Officer
Medistem Inc.
9255 Towne Centre Drive, Suite 450
San Diego, CA 92122
858 349 3617
858 642 0027
www.medisteminc.com twitter: @thomasichim
SOURCE: Medistem Inc.
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