Category Archives: Cell Medicine

June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.

"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."

With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.

"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.

"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.

In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.

Pixuvri is currently available in the EU through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

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Cell Therapeutics Appoints New Chief Medical Officer

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.

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

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed

LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models.

"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies."

Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials.

Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments.

"The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues," adds Jyothikumar. "As a result, market prices for various products may be affected."

Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies," cautions Jyothikumar. "Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics."

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New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan

13 June 2012 Last updated at 08:31 ET

Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize.

His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body.

Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine.

He was joint-winner with Linus Torvalds, who created a new open source operating system for computers.

This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award.

My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases.

The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki.

Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit humanity in the future.

"The innovations of both this year's winners embody that principle.

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Stem cell scientist wins award

13 June 2012 Last updated at 08:31 ET

Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize.

His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body.

Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine.

He was joint-winner with Linus Torvalds, who created a new open source operating system for computers.

This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award.

My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases.

The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki.

Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit humanity in the future.

"The innovations of both this year's winners embody that principle.

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Stem cell scientist wins award

Public release date: 11-Jun-2012 [ | E-mail | Share ]

Contact: Kim Irwin kirwin@mednet.ucla.edu 310-206-2805 University of California - Los Angeles Health Sciences

UCLA stem cell scientists purified a subset of stem cells found in fat tissue and made from them bone that was formed faster and was of higher quality than bone grown using traditional methods, a finding that may one day eliminate the need for painful bone grafts that use material taken from the patient during invasive procedures.

Adipose, or fat, tissue is thought to be an ideal source of cells called mesenchymal stem cells - capable of developing into bone, cartilage, muscle and other tissues - because they are plentiful and easily attained through procedures such as liposuction, said Dr. Chia Soo, vice chair for research at UCLA Plastic and Reconstructive Surgery. The co-senior authors on the project, Soo and Bruno Pault, are members of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

Traditionally, cells taken from fat had to be cultured for weeks to isolate the stem cells which could become bone, and their expansion increases risk of infection and genetic instability. A fresh, non-cultured cell composition called stromal vascular fraction (SVF) also is used to grow bone. However, SVF cells taken from adipose tissue are a highly heterogeneous population that includes cells that aren't capable of becoming bone.

Pault and Soo's team used a cell sorting machine to isolate and purify human perivascular stem cells (hPSC) from adipose tissue and showed that those cells worked far better than SVF cells in creating bone. They also showed that a growth factor called NELL-1, discovered by Dr. Kang Ting of the UCLA School of Dentistry, enhanced the bone formation in their animal model.

"People have shown that culture-derived cells could grow bone, but these are a fresh cell population and we didn't have to go through the culture process, which can take weeks," Soo said. "The best bone graft is still your own bone, but that is in limited supply and sometimes not of good quality. What we show here is a faster and better way to create bone that could have clinical applications."

The study appears June 11, 2012 in the early online edition of the peer-reviewed journal Stem Cells Translational Medicine, a new journal that seeks to bridge stem cell research and clinical trials.

In the animal model, Soo and Pault's team put the hPSCs with NELL-1 in a muscle pouch, a place where bone is not normally grown. They then used X-rays to determine that the cells did indeed become bone.

"The purified human hPSCs formed significantly more bone in comparison to the SVF by all parameters," Soo said. "And these cells are plentiful enough that patients with not much excess body fat can donate their own fat tissue."

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A better way to grow bone: Fresh, purified fat stem cells grow bone faster and better

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.

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

BACKGROUND: Tooth loss, although often associated with a diet high in sugar, has been a problem for as long as mankind has existed. Before the widespread use of refined sugar in food, tooth loss was often a result of disease and malnutrition, although dietary practices also contributed to the problem. Several studies have documented the negative aspects of not having teeth or dentures including impaired nutritional intake, lower self-confidence and self-esteem and reduced quality of life. The three most common tooth replacement options are dental implants, fixed bridges and removable appliances. (Source: perio.org)

STEM CELLS: Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell. (Source: The National Institutes of Health resource for stem cell research)

CLONING TEETH: Nova Southeastern Universitys dental researchers at the College of Dental Medicine are growing and harvesting human dental stem cells in the lab. The cells normally grow in flat layers of single cells in Petri dishes. To get them to form a 3-D tissue structure, researchers seed the cells on tissue engineering scaffolds made from the same polymer material as bio-resorbable surgical sutures. The scaffolds function like those you see around buildings under construction. They provide mechanical support and control the size and shape of a tissue. Once the stem cells are seeded on the scaffolds, researchers add growth factors to signal to the stem cells what type of tissue to grow. The combination of dental stem cells, tissue engineering scaffolds and growth factors allows researchers to engineer new tooth tissues. NSU scientists are working, similar tooth research labs, to create fully functional replacement teeth.

Dental researchers have been successful at regenerating teeth in the laboratory and in animals. They have developed a stem cell therapy for growing new teeth following root canal treatment, and also for replanting teeth that have been knocked out of the mouth. In NSUs technique for regenerating teeth, the pre-clinical trial subjects were able to eat and chew normally. No current studies have examined the ability of animals to eat using completely regenerated teeth because no one has yet regenerated all the teeth in an animal. In NSUs technique, the soft tissue, or pulp, inside teeth was removed and regenerated. The monkey subjects were able to use their teeth normally to eat and chew.

NSU is in the process of patenting a "regeneration kit" that will allow dentists to deliver stem cell therapies to replace dead tissue inside a tooth. In addition, several companies are collecting baby teeth to harvest stem cells through dental offices. The stem cells are being stored for future regenerative therapies, including growing new teeth or growing other replacement organs. (Source: NSU, Sun Sentinel)

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Cloning Teeth: Medicine’s Next Big Thing?

SAN DIEGO, CA--(Marketwire -06/07/12)- Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) announced today that its wholly owned subsidiary Regen BioPharma, Inc. has executed an exclusive option agreement which grants Regen BioPharma an option to license Patent #6,821,513 which patents methods of stimulating blood production in patients with deficient stem cells. The patent, as well as data licensed with the patent, covers methods of stimulating the bone marrow to generate new blood cells. The patent and option agreement are disclosed in the Company's most recent 8K filed with the US Securities and Exchange Commission on June 6, 2012.

"The technology has broad applicability to help cancer patients recover faster following chemotherapy, as well as for recipients of bone marrow and cord blood transplants. Currently, new blood cell production is stimulated by expensive drugs such as Neupogen and Neulasta which replicate the body's growth factors but can cause side effects and rely upon the diminished recuperative powers of an immune compromised patient," stated J. Christopher Mizer, President of Regen BioPharma.

David Koos, Chairman & CEO of Bio-Matrix Scientific Group, added, "We are excited to get this therapy into the clinic. Based on peer-reviewed published animal data, it has the potential to restore immune function faster and more effectively than the existing standard of care."

The licensed technology covers the use of a naturally-occurring cell type for stimulation of bone marrow stem cells. By utilizing cells as opposed to drugs, Regen BioPharma believes it possesses a substantial advantage to existing approaches in terms of safety and economics of production. Currently the market for growth factors that stimulate blood making stem cells is more than $4.84 billion per year (www.wikinvest.com/stock/Amgen).

About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) is a biotechnology company focused on the development of regenerative medicine therapies and tools. The Company is focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to cardiovascular, hematology, oncology and other indications.

Through Its wholly owned subsidiary, Regen BioPharma, it is the Company's goal to develop translational medicine platforms for the rapid commercialization of stem cell therapies. The Company is looking to use these translational medicine platforms to advance intellectual property licensed from entities, institutions and universities that show promise towards fulfilling the Company's goal of increased quality of life.

Disclaimer

This news release may contain forward-looking statements. 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 statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

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Bio-Matrix Scientific Group's Regen BioPharma Subsidiary Executes Option Agreement to License Stem Cell Intellectual ...

SAN DIEGO, CA--(Marketwire -06/07/12)- Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) announced today that its wholly owned subsidiary Regen BioPharma, Inc. has executed an exclusive option agreement which grants Regen BioPharma an option to license Patent #6,821,513 which patents methods of stimulating blood production in patients with deficient stem cells. The patent, as well as data licensed with the patent, covers methods of stimulating the bone marrow to generate new blood cells. The patent and option agreement are disclosed in the Company's most recent 8K filed with the US Securities and Exchange Commission on June 6, 2012.

"The technology has broad applicability to help cancer patients recover faster following chemotherapy, as well as for recipients of bone marrow and cord blood transplants. Currently, new blood cell production is stimulated by expensive drugs such as Neupogen and Neulasta which replicate the body's growth factors but can cause side effects and rely upon the diminished recuperative powers of an immune compromised patient," stated J. Christopher Mizer, President of Regen BioPharma.

David Koos, Chairman & CEO of Bio-Matrix Scientific Group, added, "We are excited to get this therapy into the clinic. Based on peer-reviewed published animal data, it has the potential to restore immune function faster and more effectively than the existing standard of care."

The licensed technology covers the use of a naturally-occurring cell type for stimulation of bone marrow stem cells. By utilizing cells as opposed to drugs, Regen BioPharma believes it possesses a substantial advantage to existing approaches in terms of safety and economics of production. Currently the market for growth factors that stimulate blood making stem cells is more than $4.84 billion per year (www.wikinvest.com/stock/Amgen).

About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) is a biotechnology company focused on the development of regenerative medicine therapies and tools. The Company is focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to cardiovascular, hematology, oncology and other indications.

Through Its wholly owned subsidiary, Regen BioPharma, it is the Company's goal to develop translational medicine platforms for the rapid commercialization of stem cell therapies. The Company is looking to use these translational medicine platforms to advance intellectual property licensed from entities, institutions and universities that show promise towards fulfilling the Company's goal of increased quality of life.

Disclaimer

This news release may contain forward-looking statements. 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 statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

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Bio-Matrix Scientific Group's Regen BioPharma Subsidiary Executes Option Agreement to License Stem Cell Intellectual ...