Stemedica Completes Pre-IND Meeting with the FDA for Ischemic Tolerant Neural Stem Cells (itNSC)

(Source: January 24 2012; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigational New Drug) application to evaluate the safety and efficacy of Stemedica's cGMP manufactured ischemic tolerant allogeneic neural stem cells (adult human) for spinal cord injury.

The proposed initial clinical trial will be a Phase I/IIa for safety and dose escalation using ischemic tolerant adult allogeneic itNSCs administered via lumbar puncture to patients with spinal cord injury and paralysis. The proposed trial will take place at medical centers within the United States.

“We appreciate the guidance and help we obtained in our FDA discussions. We are using this information to fine-tune our IND submission,” said Lev Verkh, Ph.D., Chief Regulatory & Clinical Development Officer at Stemedica.

Nikolai Tankovich, M.D., Ph.D., Stemedica’s President and Chief Medical Officer pointed out the significance of Stemedica’s itNSCs and their relevance to the research and translational medicine communities, “Stemedica has been able to achieve a number of breakthroughs in the manufacture of neural stem cells. The first involves differentiation; more than 80 percent of our stem cells differentiate into functional neurons. We have also proven in vivo that our itNSCs not only migrate, but also engraft and then demonstrate action potential. In other words, they are capable of carrying critical electrical signals.”

Stemedica’s itNSCs are derived from a single tissue source and expanded under environmentally deprived conditions. Expansion under these conditions enables the cells to function more effectively in areas of tissue damage. Using the Company’s proprietary expansion techniques, an estimated 150,000 treatment doses of 100 million stem cells per dose can be derived from this single tissue source. Furthermore Stemedica itNSCs undergo only four passages for the final product, eliminating the problems associated with contamination and mutations. In order to achieve adequate number of cells for clinical applications, most companies must complete 10 or more passages. The Company has a filed a patent application for its ischemic tolerant neural stem cells.

Maynard Howe, Ph.D., Chief Executive Officer of Stemedica noted that, “Stemedica is the only company that owns the entire manufacturing process through commercialization for multiple cells, including ischemic tolerant mescenchymal and neural stem cells. We manufacture our cells under government license and set the highest standards for purity, safety, and batch to batch consistency.” The itNSCs are manufactured in licensed facilities in San Diego, California and in Lausanne, Switzerland.

The Company’s cGMP produced stem cells are available for sale to researchers and hospitals conducting clinical trials.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The Company is currently conducting clinical trials for stroke under US IND using ischemic tolerant mesenchymal (itMSC) stem cells. Regulatory pathways for spinal cord injury, diabetic retinopathy, acute myocardial infarct, acute respiratory distress syndrome and wound repair are also underway. Stemedica is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica Perspective On Geron's Departure From The Stem Cell Industry

(November 23 2011; Stemedica Cell Technologies, Inc.)

The Geron Corporation, a biopharmaceutical company that was developing cell therapy products from differentiated human embryonic stem cells for multiple indications, recently announced that they have decided to exit the stem cell industry citing financial reasons and what is perceived to be a very long regulatory pathway for its embryonic stem cell technology

There are many opinions on how this news will impact the stem cell industry. Please read our response below.

Geron Exits Stem Cell Industry: Stemedica Response

Stemedica Neural Stem Cells Successful in Preclinical Study of Spinal Cord Injury

San Diego, CA (Source: November 14 2011; Stemedica Cell Technologies, Inc.)

Transplanted neural stem cells (NSCs) developed by Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development were successful in treating rats with spinal cord injury (SCI). The research conducted by Ivan Cheng, M.D., Assistant Professor in the Department of Orthopedic Surgery, Stanford University School of Medicine, was presented at the North American Spine Society Annual Meeting in Chicago, IL on November 2, 2011. Dr. Cheng’s paper was entitled Functional Assessment of Acute Local Versus Distal Transplantation of Human Neural Stem Cells Following Spinal Cord Injury. The data represent a significant finding in the field of spinal cord research.

Twenty-four subjects underwent a controlled injury at the T10 (thoracic) level, rendering them paraplegic. Experimental subjects received either an injection of Stemedica’s ischemic tolerant human NSCs adjacent to the site of injury (local injection), or an intrathecal injection (lumbar puncture) of NSCs distal to the site of injury. Control subjects received an injection of control media alone either local or distal to the site of injury. Subjects were assessed following injury and then weekly for six weeks.

According to Dr. Cheng, "The acute transplantation of NSCs into the rat’s injured spinal cord lead to significant functional recovery. This occurred whether the cells were injected either locally or distally. This preclinical research holds promise for patients in that we may be able to inject Stemedica NSCs through a traditional lumbar puncture in the acute phase after their injury."

Stemedica's ischemic tolerant neural stem cells were developed by Alex Kharazi, M.D., Ph.D., Chief Technology Officer at Stemedica and were made available to leading medical institutions for preclinical research. Dr. Kharazi notes that "Dr. Cheng's data in rats support our internal research. We have successfully transplanted NCSs into chicken embryonic brain and demonstrated that our NSCs engraft, migrate and differentiate into a variety of neural and glial cells."

An Investigational New Drug (IND) application for NSC use in human clinical trials is currently being prepared for submission to the Food and Drug Administration for initiation of clinical trials in Q1, 2012. The NSCs are the second product to be released by the San Diego based company. Ischemic tolerant mesenchymal stem cells are currently in a Phase I/IIa clinical trial for ischemic stroke at the University of California, San Diego School of Medicine.

Nikolai Tankovich, M.D., Ph.D., Stemedica's President and Chief Medical Officer, points to the significance of these findings, "This basic science research is encouraging for the more than 250,000 Americans who suffer from spinal cord injury, and the 11,000 who join their ranks each year. We look forward to the day when effective treatment for spinal cord injury can limit and help reverse the damage and suffering that these patients endure."

Maynard Howe, Ph.D., CEO of Stemedica noted that, "We anticipate continuing our collaboration with the researchers at Stanford University to advance a clinical trial path for patients with this debilitating condition."

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica Completed Enrollment In First Cohort Of Patients With Ischemic Stroke Utilizing Allogeneic Mesenchymal Stem Cells

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that its specially formulated ischemic adult allogeneic mesenchymal stem cells have been successfully used to treat the first cohort of patients in an ischemic stroke study conducted at the University of California, San Diego (UCSD). A total of 35 patients will be enrolled in the clinical trial entitled: “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.”

Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented: “All patients in the first cohort received an initial dose of adult allogeneic stem cells and no product related adverse events were reported. An Independent Data Safety Monitoring Board (DSMB) reviewed the safety data for the subjects including adverse events, laboratory data and vital signs and based on that review, the DSMB unanimously voted for the study to proceed to the next dose.”

The Principle Investigator Michael Levy, MD, PhD, FACS, Chief of Pediatric Neurosurgery at Children's Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego (UCSD) commented that “he is pleased with the safety profile demonstrated in this initial phase of the study and is looking forward to completing Cohorts 2 and 3 given the promising results to date.”

Patients in this study have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.

Information on enrolling in the study can be found at http://clinicaltrials.gov/ct2/results?term=stemedica.

More than 800,000 Americans suffer a stroke annually and according to the American Heart Association, stroke is the fourth leading cause of death - costing an estimated $73.7 billion in 2010 for stroke-related medical costs and disability.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trial for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stem Cell Partnership In Lebanon Announced

Amni BioScience, SAL (“AMNI”) announced today the formal signing of a long-term agreement with Clinique Du Levant Société Médicale SAL (“LEVANT”) in Beirut, Lebanon. This agreement will initiate a wide array of therapies involving the use of adult stem cell products as manufactured by Stemedica Cell Technologies under FDA (United States Federal Drug Administration) approval.

In order to maximize the rapidly expanding research and clinical application opportunities available within the fields of restorative and regenerative medicine, AMNI and LEVANT plan on playing a critical role in the full evolution of the most advanced regenerative-based therapies and services. “We’re honored to be working with a facility with the kind of outstanding leadership as LEVANT”, said Amni BioScience President Mr. Sam Alkhass. “Together, we plan on becoming a world leader in the fields of restorative and regenerative medicine.”

The agreement between AMNI and LEVANT calls for the pro-active implementation of clinical trials using allogeneic adult stem cells as manufactured by Stemedica Cell Technologies, Inc., San Diego, California (“STEMEDICA”) as well as their wholly-owned, Swiss-based subsidiary, Stemedica International. Stemedica is licensed to manufacture allogeneic adult stem cells under cGMP manufacturing practices and is regarded as a world leader in the development and manufacture of allogeneic adult stem cells. “We’re excited about the relationship that our exclusive Middle East Distributor, Amni, has agreed to with LEVANT”, said Dr. Nikolai Tankovich, Chairman of Stemedica International and President, Chief Medical Officer of Stemedica International’s parent firm, Stemedica Cell Technologies, Inc. “We look forward to developing a long and mutually-beneficial working relationship between Stemedica International, which services our Middle East operations, and partnership with LEVANT.”

Stemedica’s product line will be imported into Lebanon by Benta Pharmaceutical, (“BENTA”) the Nation’s leading Pharmaceutical Manufacturing Company. “We’re pleased to be joining Amni BioScience and Stemedica as we work together to bring the regenerative powers of allogeneic adult stem cells to Lebanon and the Middle East”, said Mr. Bernard Tannoury, Chairman of Benta. “Together we will bring the safest and most clinically advanced allogeneic adult stem cells to the region for the betterment of patients and the economy alike.”

Once all importation requirements have been met, Amni BioScience will work closely with the medial leadership of LEVANT to implement a “Clinical Trial to Commercial Pathway” strategy for one or more medical indications. According to AMNI’s Chief Medical Officer, Dr. Jean Pierre SAAB, “We’re working closely with the Ministry of Health in Lebanon, Scientific Societies and Lebanese Order of Physicians, to establish regulatory guidelines that protect patients and create the highest levels of safety and efficacy. We’re committed to helping establish “The Gold Standard” in safety and clinical trial advancements of stem cells here in Lebanon and throughout the Middle East.”

Clinique Du Levant Société Médicale SAL is regarded as one of the most prestigious medical facilities in the Middle East and is recognized for its advanced medical treatment in numerous medical categories. “We’re delighted to be working with Amni BioScience leadership and look forward to building our relationship and service offerings into the regional leader for restorative and regenerative health care. We believe our relationship with the stem cell movement is an excellent addition to the many advanced and basic medical offerings of our facility”, said Dr.Antoine Maalouf, Chairman of LEVANT.

About Amni BioScience SAL
Our vision is to build Amni into a medical powerhouse in the region through the promotion of the most advanced medical services and technologies available in the Middle East. We are bringing this vision into reality through a comprehensive series of representation, ownership and acquisition positions with a select number of targeted corporate partners and properties.
http://www.amnibioscience.com

About Clinique Du Levant Société Médicale SAL
The mission of Clinique Du Levant Société Médicale is to provide the highest quality of care and service for all people, while preserving quality of life, by attracting and supporting physicians of the highest character and greatest skill. LEVANT provides world class medical care, continual education, through highly specialized physicians, and dedicated staff. LEVANT is located in Beirut, Lebanon.
http://www.lacliniquedulevant.com

About Stemedica and Stemedica International
Stemedica Cell Technologies is a world leader in the manufacture of allogeneic adults stem cells. The company’s headquarters and primary manufacturing facility is located in San Diego, California. Based in Lausanne, Switzerland, Stemedica International is a wholly-owned subsidiary of Stemedica Cell Technologies, Inc. Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for preclinical and human clinical trials. Stemedica is headquartered in San Diego, California.
http://www.stemedica.com

Stemedica Receives Approval From UCSD To Initiate Ischemic Stroke Study With Adult Allogeneic Stem Cells

(Source: February 17 2011; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development announced today that it has received IRB approval from the University of California, San Diego (UCSD) to initiate a Stemedica clinical study entitled, “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke”. This study will enroll approximately 35 subjects with a clinical diagnosis of ischemic stroke. These patients have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.

Michael Levy, MD, PhD, FACS Chief of Pediatric Neurosurgery at Children's Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego is the principal investigator of the study. Dr. Levy looks forward to enrolling patients, and reinforces the importance of clinical stem cell research. “This is an important step forward in translational medicine. This study may help pave the way for a new therapeutic category of treatment for ischemic stroke.”

Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented, “We are pleased and delighted to be working with UCSD and Dr. Levy. We believe that progressing rapidly down the regulatory pathway may eventually provide treatment options for the 800,000 Americans who suffer a stroke each year.” According to the American Heart Association, stroke is the fourth leading cause of death, costing an estimated $73.7 billion in 2010 for stroke-related medical cost and disability.

The safety of stem cell treatment is of paramount concern to all stake holders in this emerging industry. Nikolai Tankovich, MD, PhD, President of Stemedica, highlights the Company’s relentless attention to this area. “As a cGMP government-licensed manufacturer of adult stem cells, we have also received an investigational new drug (IND) approval from the FDA for this clinical trial. Very few companies have this unique dual capacity. Our cells have gone through rigorous testing to make certain they are free from infectious agents and are not tumorigenic.”

Maynard Howe, PhD, Vice Chairman and CEO of Stemedica notes, “The medical and scientific community has much work to do in the prevention and treatment of stroke. Too many patients and family members have to cope with the aftermath of this disease. It is our hope that stem cell treatment may eventually ease the burden faced by patients and caregivers as well as curtail the extensive healthcare and rehabilitation costs.”

Information on enrolling in the study can be found at http://clinicaltrials.gov/ct2/results?term=stemedica.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica Announces the Appointment of Dr. César Amescua Garcia as Medical and Regulatory Affairs Director – Latin America

Stemedica Cell Technologies, Inc., a leader in allogeneic adult stem cell manufacturing, research and development announced today the appointment of César Amescua, MD as Medical and Regulatory Affairs Director for Latin America. Dr. Amescua will be responsible for liaison with regulatory agencies in Latin America regarding approvals of Stemedica’s stem cell products for use in clinical (human) trials which follow the criteria required by the FDA in the United States.

Dr. Amescua is a member of the senior medical leadership at Grupo Angeles, one of the largest health care providers in all of Latin America. He is also President of the Mexican Association for the Study and Treatment of Pain. “I am excited and proud to be working with Stemedica. The company is a leader in the stem cell manufacturing field, and is bringing innovative technology to countries around the world. Latin America holds great promise for Stemedica’s products and services as Latin America seeks to address the epidemic of degenerative diseases and conditions that are bankrupting health care systems around the world.”

Dr. Lev Verkh, Stemedica’s Chief Regulatory and Clinical Development Officer, commented, “We’re pleased and delighted to have Dr. Amescua joining our team at Stemedica. His medical leadership and his regulatory expertise will be critical in establishing clinical trials throughout Latin America using Stemedica stem cell products.”

“With the rapid advancement of the clinical application and development of adult stem cell therapy around the world, the addition of Dr. Amescua’s medical leadership and regulatory expertise is critical in establishing extensive clinical trials for our products,” said Dr. Nikolai Tankovich, Stemedica’s President and Chief Medical Officer.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com