SAN DIEGO, CA–(Marketwire – Mar 22, 2013) – Medistem Inc. ( PINKSHEETS : MEDS ) announced today it published an update on its RECOVER-ERC congestive heart failure Phase II clinical trial in a peer-reviewed journal (link to paper http://www.translational-medicine.com/content/pdf/1479-5876-11-56.pdf). The publication reports safety of its proprietary stem cell population, termed “Endometrial Regenerative Cells” (ERC), as well as data supporting the patent-pending 30 minute catheter-based retrograde delivery technique through which the stem cells are administered.

“To date, all stem cell trials in the cardiac space use bone marrow and adipose tissue sources. Unlike the painful and highly invasive process of collecting bone marrow and adipose stem cells, our collection processes involves extraction of a small amount of menstrual blood from young healthy donors. In our FDA-cleared manufacturing protocol, one donor generates 20,000 doses,” said Alan Lewis, Ph.D., Chief Executive Officer of Medistem. “ERC are administered without tissue matching or the requirement for immune suppressive drugs. Our product is delivered to the point-of-care as a cryogenically preserved allogeneic therapy that is ready to use, without need for end user manipulation. This feature could make it practical for clinicians to efficiently deliver stem cell therapy to large numbers of heart failure patients.”

“This is the first time that the minimally-invasive catheter-based retrograde delivery technique has been used in the context of a ‘universal donor’ stem cell,” said Amit N. Patel, M.D., Director of Cardiovascular Regenerative Medicine at the University of Utah and the senior author of this publication. “The delivery technique used in the current study can be widely performed by any licensed interventional cardiologist with minimal training. This is in contrast to other stem cell delivery techniques that require extensive user training and complex equipment that is not readily available.”

The RECOVER-ERC trial is a 60 patient, double-blind, placebo controlled study in which patients with congestive heart failure are divided into 3 groups, which receive ERC in a dose escalating manner of 50, 100,and 200 million cells. Main efficacy endpoints are at 6 months after treatment with safety endpoints assessed up to one year.

To date, 17 patients have been treated with no treatment associated adverse events reported. The Principle Investigator is Leo Bockeria, M.D., Chairman of the Bakoulev Center and Academician of the Russian Academy of Science. The Bakoulev Center is Russia’s premier institute for cardiovascular surgery and cardiology. Every year the Backulev Center performs approximately 30,000 procedures including 7,000 open heart surgeries and more than 12,000 angioplasties.

Amit Patel, M.D., is the International Principle Investigator for the trial and was the first physician to administer stem cells into the human heart.

Safety oversight for the trial is performed by the independent Data Safety Monitoring Board (DSMB) which is chaired by Warren Sherman, M.D., Director of Cardiac Cell-Based Endovascular Therapies at Columbia University.

“To my knowledge Medistem is the only company in the history of cell therapy to take a cell from discovery to FDA clearance and clinical trials in the span of 4 years,” said Dr. Chiplin. “I believe Medistem has an outstanding management team and have watched with great interest the company’s evolution. I believe the company is well positioned to transform the stem cell industry and I look forward to helping shape the company’s future as a member of the board.”

Dr. Chiplin has broad-based experience in the life science and technology industries in both leadership and investment roles. Prior to Polynoma, Dr. Chiplin was founding CEO of Arana Therapeutics, a new generation antibody developer and a board member of Domantis, Inc., prior to the acquisition of these companies by Cephalon ($329 million) and GSK ($458 million), respectively. Prior to founding Arana, Dr. Chiplin was Managing Director of U.K. based ITI Life Sciences investment Fund. Dr. Chiplin holds Pharmacy and Doctoral degrees from the University of Nottingham, UK.

“We are delighted to have John join our board. The combination of scientific and business acumen, as well as practical knowledge of biotherapeutic development that John possesses is an extremely rare combination,” said Alan Lewis, Ph.D., CEO of Medistem. “John has been involved in several successful exits, we are looking forward to synergizing with his talents at optimizing the value of our universal donor stem cell product.”

2012 was marked by significant progress in the development of the Endometrial Regenerative Cell (ERC), our new universal donor “stem cell drug.” Most significantly, we initiated a double blind, placebo controlled clinical study in patients with end stage heart failure, in which ERC were administered via the Medistem’s patent-pending minimally invasive procedure. The clinical trial comprises three escalating doses of ERC with cohorts of 20 patients per dose. To date 14 patients have been treated with no adverse effects, thus demonstrating feasibility of the administration procedure, as well as safety of the cells. Because it is a double blind study, efficacy will not be known until the trial is completed. The clinical trial is being conducted at the Backulev Center for Cardiovascular Surgery in Moscow, Russia, by Academician Leo Bockeria. The company also initiated a 15 patient critical limb ischemia trial in China in collaboration with Shanghai Jia Fu Medical Apparatus Inc. To date two patients have been treated. The trial is based on the Medistem critical limb ischemia study that has been cleared by the FDA.

In addition, we licensed from Yale University the world-wide rights for a patent application using ERC to treat Type 1 diabetes. We also initiated a program in type 1 diabetes, with the goal of filing an Investigational New Drug application before the end of 2013 to allow for clinical trial initiation.

In 2012, researchers at the National Institutes of Health (NIH) independently verified and published a peer reviewed article confirming ERC possess a markedly higher expression of genes associated with new blood vessel formation and stem cell potency compared to bone marrow mesenchymal stem cells. The publication may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-207.pdf

In addition, our intellectual property was further enhanced with the issuance of patent #8,241,621 covering the use of fat derived stem cells for treatment of autoimmune conditions such as rheumatoid arthritis, type 1 diabetes, and multiple sclerosis. We have also filed 2 patent applications covering the use of ERC for radiation protection and treatment of traumatic brain injury.

Also, in collaboration with several corporate and academic institutions we published a total of 7 peer reviewed papers in 2012 on collaborative breakthroughs we made in the areas of hepatitis, cancer, and prevention of transplant rejection.

Additionally, this year we added two new advisory board members including Gene Ray, Ph.D., and Alexander Gershman, M.D., Ph.D. Dr. Ray was founder of the Titan Corporation, where he served as CEO and a director of the corporation since the company’s inception in 1981. In 2011, Titan Corporation was acquired by L-3 Communications for $2.6 billion. Dr. Gershman is one of the first surgeons in the world to apply the method of laparoscopic surgery and robotic-assisted surgery to urology. He currently holds several hospital appointments, including: Director of Institute of Advanced Urology at the Cedars-Sinai Medical Center; Director of Urologic Laparoscopy in the Division of Urology, and Harbor-UCLA Medical Center.

Finally, this year marked a major transition in the leadership of the company. I was appointed to the position of CEO on October 26 and Dr. Thomas Ichim transitioned to the position of President and Chief Scientific Officer. Dr. Ichim has done an outstanding job leading the company for the past four years and I look forward to working closely with him at commercializing the ERC product.

In 2013 our objective will be to meet the following milestones:

• Return to “fully reporting” status and listing on the OTCBB
• Appointment of at least one new board member
• Initiation of the FDA cleared critical limb ischemia trial in the USA
• Completing enrollment in the RECOVER-ERC double blind cardiac trial
• Filing an IND for type 1 diabetes.

I want to end by thanking our loyal shareholders for their continued support as Medistem continues on its mission to generate the first practical “stem cell medicine.”

Sincerely Yours,

Dr. Alan Lewis
Chief Executive Officer
Medistem Inc.

SAN DIEGO, CA–(Marketwire – Nov 19, 2012) – Medistem ( PINKSHEETS : MEDS ) announced today appointment of Alexander Gershman, MD, Ph.D to the company’s Scientific Advisory Board. Dr. Gershman is an internationally-renowned opinion leader in urological surgery having pioneered numerous minimally invasive procedures using laparoscopic techniques.

“The future of regenerative medicine lies not only in having the best stem cell product, but also being able to practically deliver it in a manner that can be integrated into existing medical practice,” said Dr. Alan Lewis, CEO of Medistem. “Through working with respected physicians such as Dr. Gershman, our aim is to develop novel delivery methods so that our cellular product can be utilized in numerous disciplines.”

Medistem is currently running a Phase II clinical trial in heart failure patients using its Endometrial Regenerative Cell (ERC) product delivered through a 30-minute minimally invasive patent pending procedure. The company seeks to develop similar minimally invasive procedures for the field of urology in collaboration with Dr. Gershman.

“It is obvious that stem cell medicine is the future of medicine. Although great strides have occurred in clinical entry of stem cells, a major hurdle to commercialization is practical implementation,” said Dr. Gershman. “I commend Medistem for having discovered what appears to be the most potent blood vessel generating stem cell, the ERC, as well as having the foresight to think practically about optimum methods of delivery.”

Dr. Gershman is one of the first surgeons in the world to apply the method of laparoscopic surgery and robotic-assisted surgery to urology. He currently holds numerous hospital appointments, including the following: Director of Institute of Advanced Urology at the Cedars-Sinai Medical Center; Director of Urologic Laparoscopy in the Division of Urology, Harbor-UCLA Medical Center; Head of Endourology Division, Department of Surgery, VA Greater Los Angeles Healthcare System; Attending Surgeon, Laparoscopic Renal Transplant Surgery, St. Mary Medical Center; Attending Surgeon at the Cedars-Sinai Medical Center; and Attending Surgeon at the Harbor-UCLA Medical Center.

SAN DIEGO–(BUSINESS WIRE)–

Medistem announced today Dr. Alan Lewis, the recently appointed CEO of Medistem, will be presenting at the Stem Cells on the Mesa meeting. The company will discuss its ongoing programs at creating effective treatments for cardiovascular diseases using the Endometrial Regenerative Cell (ERC), a stem cell derived from menstrual blood.

“The lining of the uterus is unique in its ability to create large numbers of new blood vessels monthly. We found that the cells responsible for creation of new blood vessels, the ER, are shed into the menstrual blood. The ERC have now been cleared by the FDA for clinical trials,” said Dr. Lewis. “Currently we are pursuing clinical trials in patients with heart failure and critical limb ischemia, an advanced form of peripheral artery disease. In both of these conditions we anticipate the production of new blood vessels will lead to therapeutic responses.”

The NIH has recently published that Medistem’s ERC possess a unique genetic profile associated with stimulation of new blood vessel growth. The paper may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-207.pdf

“We are excited about the commercialization potential of these cells, given that one donor can generated 20,000 treatment doses,” said Thomas Ichim, President and Chief Scientific Officer of Medistem.

Medistem’s presentation will be at 5:30 PM, Monday, October 29th, 2012, Location: Sanford Consortium, 2880 Torrey Pines Scenic Drive, La Jolla, CA.

The 2012 Stem Cell Meeting on the Mesa is aimed at bringing together senior members of the business development and scientific research communities in regenerative medicine to advance stem cell science into cures for debilitating diseases and injuries. The meeting features a nationally recognized Scientific Symposium attended by more than 600 leading scientists and researchers alongside the regenerative medicine industry’s premier annual Investor and Partnering.

Medistem Inc. (PINKSHEETS: MEDS) announced today a peer-reviewed publication led by NIH scientists demonstrating that the company’s Endometrial Regenerative Cells (ERC) possess a unique genetic signature associated with production of new blood vessels (angiogenesis).

“The demonstration by an independent group that ERC possess a unique gene signature compared to other stem cells, and that the gene signature is associated with production of new blood vessels, is a strong validation for our programs,” said Dr. Thomas Ichim, President and CSO of Medistem. “These data support original publications by our group and others that have demonstrated ERC appear to be nature’s regenerative powerhouse for production of new blood vessels.”

According to the publication, the gene encoding aldehyde dehydrogenase, a marker of stem cell potency, was expressed 39.5-fold higher in ERC as compared to bone marrow mesenchymal stem cells (MSC). Additionally, genes associated with production of new blood vessels such as MMP-3, angiopoietin, and PDGF, were expressed 29-fold, 13-fold, and 26-fold higher in ERC as compared to bone marrow MSC, respectively.

“Currently the majority of scientific effort in development of stem cell therapeutics is associated with bone marrow stem cells. While bone marrow stem cells have many excellent properties, the stem cells we are clinically developing are derived from the endometrium. This is the only part of the body that renews itself every month by producing new blood vessels. The findings today that the ERC stem cell appears to have a gene signature that is different than bone marrow, further supports our hypothesis that the ERC is a unique cell that acts as the natural angiogenic ‘repair cell’ of the body,” said Dr. Amit Patel, Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah.

Currently Dr. Patel is the International Investigator for the RECOVER-ERC Phase II clinical trial which involves administration of ERC into patients with heart failure via a novel 30 minute delivery process. Heart failure and critical limb ischemia, which are Medistem’s 2 clinical programs, have both been demonstrated to benefit from stimulation of new blood vessel production. Medistem has received clearance from the FDA to perform clinical trials in critical limb ischemia.

The publication may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-207.pdf

SAN DIEGO–(BUSINESS WIRE)–

Medistem Inc. (PINKSHEETS: MEDS) announced today appointment of Dr. Alan Lewis to the position of Chief Executive Officer and Member of the Board. Since January, Dr. Lewis has been functioning in the capacity of Scientific Advisory Board Member for Medistem.

“We are enthusiastic that Dr. Lewis is taking the helm to help accelerate clinical development of the Endometrial Regenerative Cell (ERC) universal donor stem cell product, which is already in Phase I and Phase II studies for critical limb ischemia and congestive heart failure, respectively,” said Dr. Vladimir Bogin, Chairman of Medistem. “Dr. Thomas Ichim is assuming the role as the company’s President and Chief Scientific Officer.”

Dr. Lewis spent 15 years at the pharmaceutical company Wyeth-Ayerst, where he was Vice President of Research, leading translational research efforts in diabetes, CNS, cardiovascular, inflammatory, allergy and bone metabolism diseases. He subsequently became CEO of Signal Pharmaceuticals, a drug development company that he successfully merged with Celgene. He became CEO of Novocell Inc (Viacyte) and subsequently served as CEO of the Juvenile Diabetes Research Foundation, the largest research funding body for diabetes. Most recently he was CEO of Ambit Biosciences. He currently serves on the board of BioMarin (BMRN) and a number of private biotechnology companies.

“To date the Medistem team has demonstrated remarkable accomplishments by taking a stem cell from discovery to FDA clearance in the short span of 4 years, thus positioning the company as having the longest patent life among clinical-stage stem cell companies,” said Dr. Lewis. “In contrast to other types of stem cells, Medistem’s ERC appears to be the most potent at stimulating production of new blood vessels. In addition, ERC’s proven ability to differentiate into multiple tissue types has a potential to treat numerous indications.”

Medistem has licensed intellectual property from Yale University related to using ERC to treat Type 1 Diabetes, which the company plans to develop into its third area of clinical trials.

RuiYi, a San Diego-Shanghai drug discovery company, has obtained world-wide rights to an IL-6 mAb from ArGEN-X, a Dutch firm. The molecule is being developed as a potential treatment for cancer and inflammatory diseases. RuiYi’s operations are in Shanghai’s Zhangjiang Hi-Tech Park, while its management offices are in San Diego. RuiYi focuses its expertise on biologic drugs, using them to target G protein coupled receptors.

Vital Therapies, a San Diego company that is developing a device to treat liver failure, has closed a $16 million capital round from its existing investors, the first of a planned $76 million multi-stage commitment. Last year, Vital Therapies raised $2 million from Jilin Aodong Medicine (SHE: 000623) and was slated to receive an additional $25 million in six months if Vital Therapies was successful in obtaining SFDA approval of its device. The approval was not secured.

Sanofi (NYSE: SNY) and Sinopharm (China State Institute of Pharmaceutical Industry) signed a MOU in Shanghai to conduct joint research into rare diseases (see story). Although details haven’t been released, the collaboration will apparently survey the incidence of rare diseases in China, then seek to understand causes and find treatments. In 2011, Sanofi paid $20 billion to acquire US-based Genzyme, a specialist in rare diseases.

MediStem (MEDS.PK) of San Diego formed a stem cell collaboration with Superview Biotechnology Co., a subsidiary of Yinhuan Holding (see story). The two companies will use MediStem’s proprietary stem cell lines to screen monoclonal antibodies. Their goal will be to assess whether antibodies can modulate the activity of stem cells that already exist in the body. The companies will evaluate various candidates jointly, as well as apply for grants and share research data.

Trials and Approvals

A China National Biotech Group (CNBG) vaccine for Japanese encephalitis is about to be the first vaccine from China approved for use by the World Health Organization (WHO). Once the vaccine is awarded “prequalification status,” NGOs such as the Global Alliance for Vaccines and Immunization (GAVI) can purchase it for distribution in less-developed areas as the world. The Chengdu Institute, one of China Biotech’s subsidiaries, developed and produces the vaccine.

CRO/CMO News

QPS Holdings, an international CRO based in the US, has opened an office in Beijing from which it will offer clinical-stage services. The new office will be part of QPS Qualitix, a QPS majority-owned subsidiary that already has facilities in Taiwan and India. According to QPS Qualitix, it has been operating in China through partners. Building on that experience, it will offer customized plans to clients who seek China approval of their products.

Medistem Inc (Pink Sheets:MEDS) announced today the initiation of a collaboration with Superview Biotechnology Co. Ltd, a subsidiary of Yinhuan Holding Co from Yixing, China. The joint work will be aimed at using proprietary stem cell lines developed by Medistem for screening of monoclonal antibodies for therapeutic activity in the area of regenerative medicine. As part of the collaboration, the two companies will evaluate various candidates jointly, as well as apply for grants and share research data.

“To date, the majority of stem cell companies are focusing on the stem cell itself being a product. By collaborating with Superview Biotechnology, we aim to assess the feasibility of developing antibodies that can modulate the activity of stem cells that already exist in the body,” said Thomas Ichim, CEO of Medistem. “This approach not only provides methods of activating stem cells but also allows for the development of stem cell adjuvant therapies that could be used to resurrect stem cell candidates that failed in clinical trials.”

Superview Biotechnology has developed proprietary methods of rapidly generating monoclonal antibodies to esoteric protein targets. Medistem has a history of success in the area of stem cells, being the only company to take a stem cell product from discovery to FDA clearance in the short span of 4 years.

“One of the significant driving forces behind our company is to develop innovative targets for our monoclonal antibodies. Although monoclonal antibodies have generated sales of billions of dollars in areas ranging from rheumatoid arthritis, to cancer, to preventing blindness, we feel that the potential of this therapeutic tool is only beginning to be recognized,” said Jiong Wu, CEO of Superview Biotechnology. “Our opinion is that the barriers to entry for monoclonal antibody-based therapies modulating endogenous stem cells is lower than stem cell based therapies. We are eager to work with the Medistem team at exploring this hypothesis.”

A joint grant is expected to be filed with the National Natural Science Foundation of China to support part of the proposed collaboration by end of October, 2012.

SAN DIEGO–(BUSINESS WIRE)–

Medistem Inc (Pink Sheets:MEDS), a clinical stage adult stem cell company, today announced that its CEO Dr. Thomas Ichim will attend and present at BIOX; Noble Financial Capital Markets’ Life Sciences Exposition to be held at the University of Connecticut, Stamford Campus on September, 24^th at 9 AM.

Following the event, a high-definition video webcast of Medistem’s presentation and a copy of the presentation materials will be available on the Company’s web site www.medisteminc.com, or through the Noble Financial websites: www.noblefcm.com, or www.nobleresearch.com/BioExposition.htm. You will require a Microsoft SilverLight viewer (a free download from the presentation link) to participate. The webcast will be archived on www.medisteminc.com for 90 days following the event.

A short video describing Medistem and its new universal donor stem cell product, the Endometrial Regenerative Cell (ERC) can be found at http://youtu.be/uoX8TPNquXY.

About Medistem

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. Currently the company is running clinical trials for these two indications.

About Noble Financial

Noble Financial Capital Markets was established in 1984 and is an equity research driven, full-service, investment banking boutique focused on life sciences, technology and media, emerging growth, companies. The company has offices in New York, Boston, New Jersey, Los Angeles, and Boca Raton, FL. In addition to non-deal road shows and sector-specific conferences throughout the year, Noble Financial hosts its large format annual equity conference in January in South Florida featuring 150 presenting companies from across North America and total attendance of close to 600. For more information: www.noblefcm.com