Stem Cell Clinic

Researchers' embryonic stem-cell advance decried as morally troubling

Washington

As Oregon scientists announced Wednesday they had successfully converted human skin cells into embryonic stem cells, the chairman of the U.S. bishops' Committee on Pro-Life Activities warned that the technique is morally troubling on many levels.

Scientists at the Oregon Health & Science University and the Oregon National Primate Research Center announced they had successfully reprogrammed human skin cells to become embryonic stem cells, which are capable of transforming into other types of cells that could replace those damaged by illness or injury.

Many news reports on the announcement referred to the research as human cloning, but the university's release and a full report on the work in Cell magazine carefully avoided the term, except to say taking the work in the direction of reproductive cloning is unlikely.

The Oregon research team developed the unfertilized embryonic cells to seven days' growth in a lab. Cardinal Sean O'Malley of Boston, who chairs the bishops' committee, said the process created and destroyed more than 120 human embryos, which the church considers human life that must be protected.

"Creating new human lives in the laboratory solely to destroy them is an abuse denounced even by many who do not share the Catholic Church's convictions on human life," O'Malley's statement said. He also decried the conditions to which the women who volunteered for the experiment were subjected to increase the number of eggs they produced, saying it "put their health and fertility at risk."

The researchers said their goal is to produce genetically matched stem cells for research and possible therapies, but O'Malley said the same goals can be achieved "by scientific advances that do not pose these grave moral wrongs."

Research using adult stem cells, or those derived after someone is born, as opposed to cells from embryos has provided promising possibilities for treating some illnesses or injuries. The reprogrammed stem cells can be used to replace damaged cells.

A statement from the university said the process announced Wednesday "is a variation of a commonly used method called somatic cell nuclear transfer. ... It involves transplanting the nucleus of one cell, containing an individual's DNA, into an egg cell that has had its genetic material removed. The unfertilized egg cell then develops and eventually produces stem cells."

Although the university's explanation of the breakthrough noted the research "does not involve the use of fertilized embryos, a topic that has been the source of a significant ethical debate," that doesn't address the Catholic church's moral objections.

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Researchers' embryonic stem-cell advance decried as morally troubling

Cytomedix to Present at the World Stem Cells & Regenerative Medicine Congress 2013

GAITHERSBURG, MD--(Marketwired - May 17, 2013) - Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Edward Field, the Company's Chief Operating Officer, has been invited to make a presentation on Partnering & Collaboration at the World Stem Cells & Regenerative Medicine Congress 2013, which will be held May 21-23, 2013 in London, United Kingdom.

Presentation Details

Time: Tuesday, May 21, 2013 @ 11:55am BST (6:55 am EST)

Track Title: Commercialisation through Collaboration: What Does Partnering In This Industry Actually Look Like?

Location: Victoria Park Plaza Hotel, London, UK

During the presentation, Mr. Field will highlight Cytomedix's two collaborations that are advancing clinical stage therapies.The first is a collaboration with the National Institute of Health (NIH) and the Cardiovascular Cell Therapy Research Network (CCTRN) for conduct of the PACE study, an 80 patient, double-blind, placebo-controlled clinical trial designed to look at the safety and efficacy of ALD-301 in peripheral artery disease patients diagnosed with intermittent claudication.This is the first ever randomized clinical trial to look at the benefits of autologous stem cell therapy in this indication.The second collaboration is with Duke University Medical Center, which is conducting a Phase 1 clinical study with ALD-451 in patients that have been treated for glioblastomas, which is the most aggressive form of brain cancer.This open-label study is designed to enroll up to 12 patients and is intended to demonstrate the safety and feasibility of ALD-451 when administered intravenously in patients with grade IV malignant glioma following surgery, radiation therapy and treatment with temozolomide.

About the World Stem Cells Regenerative Medicine Congress 2013The World Stem Cells & Regenerative Medicine Congress 2013 is Europe's largest and most senior conference for the stem cell research and regenerative medicine community.It is now in its 8th year. Topics covered will include streamlining clinical development, commercialising a stem cell-based therapy and exploiting alternative sources of funding. For more information please visit: http://www.terrapinn.com/2013/stemcells/index.stm.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDH") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor Statement - Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company's ability to successfully integrate the Aldagen acquisition, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2012, as amended to date, and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix to Present at the World Stem Cells & Regenerative Medicine Congress 2013

Stem-Cell-Based Strategy Boosts Immune System in Mice

UCSF Study Holds Promise for Treatment

Newswise Raising hopes for cell-based therapies, UC San Francisco researchers have created the first functioning human thymus tissue from embryonic stem cells, in the laboratory. The researchers showed that, in mice, the tissue can be used to foster the development of white blood cells the body needs to mount healthy immune responses and to prevent harmful autoimmune reactions.

The scientists who developed the thymus cells which caused the proliferation and maturation of functioning immune cells when transplanted said the achievement marks a significant step toward potential new treatments based on stem-cell and organ transplantation, as well as new therapies for type-1 diabetes and other autoimmune diseases, and for immunodeficiency diseases.

Starting with human embryonic stem cells, UCSF researchers led by Mark Anderson, MD, PhD, an immunologist, and Matthias Hebrok, PhD, a stem-cell researcher and the director of the UCSF Diabetes Center, used a unique combination of growth factors to shape the developmental trajectory of the cells, and eventually hit upon a formula that yielded functional thymus tissue.

The result, reported in the May 16, 2013 online edition of the journal Cell Stem Cell, is functioning tissue that nurtures the growth and development of the white blood cells known as T cells. T cells are a central immune cell population that responds to specific disease pathogens and also prevents the immune system from attacking the bodys own tissues.

The thymus might be a bit obscure to the layperson its a small gland at the top of the chest beneath the breastbone but it is in no way expendable, as individuals with defective thymus function succumb to infection early in life.

Given the invasive nature of cell therapy, which remains completely experimental, the first treatments using laboratory-derived thymus tissue would likely be studied in patients with fatal diseases for which there are no effective treatments, Anderson said. For example, one early treatment might be for the genetic disease DeGeorge syndrome, in which some newborns are born without a thymus gland and die in infancy.

However, a potentially greater impact may be in the area of tissue transplantation, a goal of the emerging field of stem-cell based therapies. Stem-cell-based therapies now are limited by the potential for the immune system to reject transplanted stem cells, Anderson said. For transplantation, stem cells might be coaxed down two developmental pathways simultaneously, to form both thymus tissue and a replacement organ. Transplantation of both might overcome the rejection barrier without the need for harmful immunosuppression, according to Anderson.

The thymus is an environment in which T cells mature, and where they also are instructed on the difference between self and non-self, Anderson said. Some T cells are prepared by the thymus to attack foreign invaders including transplants, while T cells that would attack our own tissues normally are eliminated in the thymus.

In the same vein, thymus tissue might one day be used to retrain the immune system in autoimmune diseases in which the immune system abnormally attacks self, thereby enhancing recognition and protecting from immune destruction.

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Stem-Cell-Based Strategy Boosts Immune System in Mice

Stem Cell Therapeutics to Begin Trading on the U.S. OTCQX Marketplace

TORONTO, ONTARIO--(Marketwired - May 16, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS), a biopharmaceutical company developing cancer stem cell-related technologies, today announced that the Company's stock will trade on OTCQX International under the symbol "SCTPF" starting May 20. OTCQX is the premier U.S. Over-The-Counter marketplace, allowing international companies increased access and exposure to the U.S. market.

Roth Capital Partners will be the market maker for Stem Cell Therapeutics' stock and will also serve as the Company's Principal American Liaison (PAL) on OTCQX, responsible for providing guidance on OTCQX requirements and U.S. securities laws. Roth Capital Partners is an investment banking firm dedicated to the small-cap public market and has been an innovator in this market since its inception in 1984.

"The U.S. capital markets are critically important in assuring viability of life sciences companies internationally and we undertake this step as part of a deliberate and long-term strategy," commented Stem Cell Therapeutics' Chairman David Allan. "The admission to the OTCQX is one of several undertakings that the company committed to complete this year. The acquisition of Trillium, the in-licensing of the tigecycline program and the recent completion of dosing in the interstitial cystitis trial are among the others."

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT), a Toronto-based biopharmaceutical company, is Canada's only public company dedicated to advancing cancer stem cell discoveries into novel and innovative cancer therapies. Building on over half a century of leading and groundbreaking Canadian stem cell research, the company is supported by established links to multiple Toronto academic institutes and oncology treatment centers that represent one of the world's most acclaimed cancer research hubs. SCT's lead clinical program, which targets a metabolic pathway in leukemia blasts and leukemic stem cells, is currently being evaluated in a multi-centre Phase I study in patients with relapsed or refractory Acute Myeloid Leukemia (AML). The Company also has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumors. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors. For more information, visit: http://www.stemcellthera.com

Caution Regarding Forward-Looking Information:

This press release may contain forward-looking statements, which reflect SCT's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include changing market conditions; the successful and timely completion of pre-clinical and clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development risks; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in SCT's ongoing quarterly and annual reporting. Except as required by applicable securities laws, SCT undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Stem Cell Therapeutics to Begin Trading on the U.S. OTCQX Marketplace

Cell Cure Neurosciences awarded $1.5m Chief Scientist grant

Stem cell company Cell Cure Neurosciences has been awarded a NIS 5.34 million (about $1.5 million) grant for 2013 from Israels Chief Scientist at the Ministry of the Economy (formerly Industry, Trade and Labor). The grant will help finance the development of OpRegen, a cell-based therapeutic product being developed by Cell Cure Neurosciences for the treatment of age-related macular degeneration. The company plans completing preclinical testing of OpRegen and filing an application to commence human clinical trials in 2014.

Cell Cure CEO Dr. Charles Irving said, "The dry form of age-related macular degeneration is one of the leading diseases of aging and is estimated to afflict over 7.3 million people in the US alone. We anticipate that OpRegen will make a real difference in the quality of life of the aging baby-boom generation in many industrialized countries, and hence it is a strategic investment for the world as a whole.

Cell Cure is developing therapeutic cells for the treatment of retinal and neural degenerative disease. Founded in 2005, the company's technology platform is based on manufacturing diverse cell products sourced from clinical grade human embryonic stem cells. In 2010, BioTime acquired a majority interest in Cell Cure and has made a subsequent direct investment by together with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Hadasit Bio Holdings Ltd. (TASE:HDST; Bulletin Board: HADSY).

Published by Globes [online], Israel business news - http://www.globes-online.com - on May 16, 2013

Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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Cell Cure Neurosciences awarded $1.5m Chief Scientist grant

Stem Cell Therapeutics Announces Completion of Dosing in Phase I Study of TTI-1612 in Patients With Interstitial …

TORONTO, ONTARIO--(Marketwired - May 16, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS), a biopharmaceutical company developing cancer stem cell-related technologies, today announced that its wholly owned subsidiary Trillium Therapeutics has completed dosing in its Phase I study of TTI-1612 in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The study was designed to assess the safety and tolerability of single ascending doses of TTI-1612 in IC/BPS patients. Pharmacokinetics and changes in disease symptoms were also evaluated. A total of 28 patients were enrolled at four urology clinics in Southern Ontario. Preliminary data indicate that the drug is well tolerated and exhibits a favourable pharmacokinetic profile. Full results are expected to be published at a later date.

IC/BPS, also known as Painful Bladder Syndrome, is a chronic, debilitating and poorly treated bladder disease affecting millions of people. The disease is believed to develop as a result of dysfunction in the protective epithelial layer lining the bladder. TTI-1612, a locally-delivered recombinant growth factor, is being developed to correct the dysfunction and restore the bladder epithelium to a normal, healthy state.

This urology program, acquired by Stem Cell Therapeutics through its recent merger with Trillium Therapeutics, targets an indication of high unmet need and represents a substantial market opportunity. However, with its current focus on oncology and cancer stem cells, the Company will now actively seek a development partner to conduct the next phase of the clinical development program.

"Completing dosing in this clinical study in a timely manner is a significant early milestone in the development of TTI-1612," commented Dr. Bob Uger, the Company's Chief Scientific Officer. "We are encouraged by our clinical experience to date with this drug, and believe we are setting the groundwork for a partner to move this program forward into Phase II testing."

About Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS):

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic bladder disease characterized by increased urinary urgency and/or frequency, nocturia (waking from sleep to urinate) and pelvic pain. These symptoms are often severe, and can impact both the physical and emotional health of patients. For many IC/BPS sufferers the disease adversely affects all major aspects of their lives, including social relationships, travel, leisure activities and employment. Once considered a rare disease, IC/BPS is now recognized as an increasingly common medical problem. Recently, a large epidemiological study found that 3.3 to 7.9 million women and 2 million men in the US alone suffer from IC symptoms. Current therapies often provide inadequate relief, and many IC/BPS patients report dissatisfaction with available treatment options. Since the current pipeline of new IC/BPS drugs is largely focused on analgesics and is unlikely to significantly alter the IC treatment landscape, novel and innovative approaches to treatment are needed.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT), a Toronto-based biopharmaceutical company, is Canada's only public company dedicated to advancing cancer stem cell discoveries into novel and innovative cancer therapies. Building on over half a century of leading and groundbreaking Canadian stem cell research, the company is supported by established links to multiple Toronto academic institutes and oncology treatment centers that represent one of the world's most acclaimed cancer research hubs. SCT's lead clinical program, which targets a metabolic pathway in leukemia blasts and leukemic stem cells, is currently being evaluated in a multi-centre Phase I study in patients with relapsed or refractory Acute Myeloid Leukemia (AML). The Company also has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumors. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors. For more information, visit: http://www.stemcellthera.com

Caution Regarding Forward-Looking Information:

This press release may contain forward-looking statements, which reflect SCT's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include changing market conditions; the successful and timely completion of pre-clinical and clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development risks; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in SCT's ongoing quarterly and annual reporting. Except as required by applicable securities laws, SCT undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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At actress's Geneva jewel auction, $3M for 1 gem

GENEVA (AP) Sotheby's auctioned off $78 million in jewels Tuesday night, fetching just under $3 million for a fancy yellow diamond belonging to actress Gina Lollobrigida that was once owned by a shah of Persia and she hoped would now bring more support for stem cell research.

The auction house said the diamond was a highlight in a collection of 23 jewels that the 85-year-old actress, who starred opposite Humphrey Bogart, Frank Sinatra and other top actors in the 1950s and 1960s, was selling partly to fund an international hospital for stem cell treatment.

Jewelry, watches and other luxury items are sold every spring by the big auction houses at Geneva's elegant lakefront hotels seemingly a world away from some European countries whose economies are shrinking as their governments enact often tough budget austerity measures to get a handle on their debts.

The 74.53-carat fancy yellow diamond that was sold off once belonged to Ahmad Shah Qajar, the shah of Persia from 1909 to 1925 and the last ruler of the Qajar dynasty. Its sale for $2,985,750 set both an auction record and a record price per carat an eye-popping $40,061 per carat for a fancy yellow diamond, according to a statement Sotheby's issued at the conclusion of the auction.

Sotheby's said eight bidders fought for Lollobrigida's natural pearl earrings, which finally sold for $2.39 million and set a new auction record for such an item.

Lollobrigida said after the auction that her jewels had brought her much pleasure for many years, and she only thought of selling them after seeing a little girl named Sofia suffering from a disorder that required stem cell treatment which she could not find in her native Italy.

"Selling my jewels to help raise awareness of stem cell therapy, which can cure so many illnesses, seems to me a wonderful use to which to put them," she said. "It is my hope that the Italian parliament will approve this ground-breaking treatment, so that children and adults in Italy should have free access to it without having to travel abroad at great expense."

David Bennett, chairman of Sotheby's Switzerland and its European and Middle East jewelry departments, said Lollobrigida's collection included some of the finest designs created by Bulgari in the 1950s and 1960s, and their sale reflects her generosity and humanitarian work.

Her jewels were just the top draw at an auction of hundreds of pieces that Sotheby's said brought in an estimated $78,229,556.

Among the other items auctioned off was Barcelona star Lionel Messi's Audemars Piguet No. 10 Royal Oak Chronograph wristwatch, which sold for $81,850 to raise money for the four-time FIFA player of the year's foundation.

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At actress's Geneva jewel auction, $3M for 1 gem

OncoMed Pharmaceuticals Initiates Phase 1b/2 Clinical Trial of Anti-Cancer Stem Cell Therapeutic OMP-59R5 (Anti-Notch2 …

REDWOOD CITY, Calif.--(BUSINESS WIRE)--

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced clinical progress with its Anti-Notch2/3 (OMP-59R5) product candidate, which will trigger an $8 million milestone payment from the companys strategic collaborator GlaxoSmithKline (GSK).

OncoMed has initiated a Phase 1b/2 clinical trial in its anti-Notch2/3 antibody (OMP-59R5) program. In the Phase 1b/2 PINNACLE trial (Phase 1b/2 INvestigation of anti-Notch Antibody therapy with Cisplatin and etoposide in small cell Lung carcinoma Efficacy and safety), Anti-Notch2/3 is being tested in combination with cisplatin and etoposide in first-line extensive-stage SCLC patients. Following a Phase 1b dose escalation and expansion phase, a randomized Phase 2 clinical trial will proceed in these patients to compare the efficacy of standard-of-care cisplatin and etoposide either with Anti-Notch2/3 or with placebo. The primary endpoint of the Phase 2 part of the trial will be progression-free survival (PFS) in the Anti-Notch2/3 arm compared to a placebo arm in patients who have a particular biomarker. Key secondary and exploratory endpoints include overall survival, response rate, and safety. Enrollment of patients in both the U.S. and Europe is planned.

Dr. Robert Jotte, Developmental Co-Chair for US Oncology Lung Committee and Medical Oncologist at Rocky Mountain Cancer Centers in Denver, CO and a Principal Investigator of PINNACLE, who treated the first patient on the study noted, It is exciting to bring a treatment like Anti-Notch2/3, with a novel anti-cancer stem cell mechanism, to patients with small cell lung cancer. This disease is an aggressive form of cancer where patients are in need of new treatment options. We hope PINNACLE yields important data for these patients.

The PINNACLE study represents the second proof-of-concept study for OncoMeds Anti-Notch2/3 program. In 2012, OncoMed initiated the first Ph1b/2 Anti-Notch2/3 clinical trial called ALPINE trial (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) in first-line advanced pancreatic cancer patients. Recently, the ALPINE study has been amended to test the new chemotherapy standard-of-care of gemcitabine and Abraxane with Anti-Notch2/3 therapy. The ALPINE study is currently enrolling patients.

The initiation of the Ph1b/2 PINNACLE trial represents another major strategic and financial milestone for OncoMed as we continue to advance our first-in-class clinical pipeline of anti-cancer stem cell therapeutics, said Paul Hastings, President and Chief Executive Officer of OncoMed Pharmaceuticals. We have now initiated two proof-of-concept trials for our novel Anti-Notch2/3 antibody in the high un-met medical need indications of small cell lung cancer and pancreatic cancer. Additionally, the potential companion diagnostic biomarkers in these trials may help preselect patient candidates for the studies.

About OMP-59R5

OMP-59R5 is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Initially discovered by screening a phage display library against the Notch2 receptor, the antibody binds to a conserved epitope on Notch2 and Notch3. Preclinical studies have suggested that OMP-59R5 exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, OMP-59R5 appears to have anti-CSC effects, and (2) OMP-59R5 affects pericytes, impacting stromal and tumor microenvironment. The program is currently in two Phase 1b/2 proof-of-concept trials in cancer indications: 1) the Phase1b/2 ALPINE trial (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) is testing Anti-Notch2/3 with gemcitabine and Abraxane in first-line advanced pancreatic cancer patients; 2) the Phase 1b/2 PINNACLE trial (Phase 1b/2 INvestigation of anti-Notch Antibody therapy with Cisplatin and etoposide in small cell Lung carcinoma Efficacy and safety), is testing Anti-Notch2/3 in combination with cisplatin and etoposide in first-line extensive stage SCLC patients. OMP-59R5 is part of OncoMeds collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to OMP-59R5 during certain time periods through completion of the proof-of-concept Phase 2 trials.

About Cancer Stem Cells

Cancer stem cells, or CSCs, are the subpopulation of cells in a tumor responsible for driving growth and metastasis of the tumor. CSCs, also known as tumor-initiating cells, exhibit certain properties which include the capacity to divide and give rise to new CSCs via a process called self-renewal and the capacity to differentiate or change into the other cells that form the bulk of the tumor. Common cancer drugs target bulk tumor cells but have limited impact on CSCs, thereby providing a path for recurrence of the tumor. OncoMeds product candidates target CSCs by blocking self-renewal and driving differentiation of CSCs toward a non-tumorigenic state, and also impact bulk tumor cells. OncoMed believes its product candidates are distinct from the current generations of chemotherapies and targeted therapies, and have the potential to significantly impact cancer treatment and the clinical outcome of patients with cancer.

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OncoMed Pharmaceuticals Initiates Phase 1b/2 Clinical Trial of Anti-Cancer Stem Cell Therapeutic OMP-59R5 (Anti-Notch2 ...