Leading Experts Endorse Bioheart’s Muscle Stem Cell MyoCell Therapy
July 8, 2009 by biotech-source.com · 1 Comment
Bioheart, Inc., (OTCBulletinBoard: BHRT) announced today that the panel discussion on myoblast (muscle stem cell) therapy between distinguished physicians and scientists is available for playback at the following site:
http://www.bioheartinc.com/news.php#060409
After reviewing supporting pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (nearly 400 patients), a panel of experts strongly endorses moving forward to complete the final phase of clinical trials (MARVEL) to advance muscle stem cell (myoblast) therapy for treating heart failure to mainstream use with FDA approval and CMS reimbursement. The MARVEL II program aims to streamline both screening and follow-up to facilitate enrollment and to enhance safety monitoring.
During the panel discussion, Dr. Christopher O’Connor, Director Heart Center, Duke University Medical Center commented on the MARVEL program “We believe it is an endeavor worthy of strong support. It is hopeful that MARVEL II, which is one stage of the broader MARVEL program, will meet a key efficacy end point – the six-minute walk.” Dr. Carl Pepine, MD, Professor of Medicine, University of Florida College of Medicine, discussed the difficulties of stem cell therapy in scar tissue. “Cells of the myoblast variety seem to be able to overcome this barrier…and this is what’s so exciting about the myoblast trials that Bioheart has proposed. We are very encouraged and would like very much to continue these trials.”
Highlights from the call include Dr. Doris Taylor’s, Director, Center for Cardiovascular Repair, University of Minnesota, recollection of the more than 20 years of research in this field. “I’ll never forget the home run. We were able to show that we could grow new muscle in the center of ischemic myocardium and improve functional outcome.” Dr. Nabil Dib, Director, Cardiovascular Research, Mercy Gilbert & Chandler Medical Centers, added that “Myoblast transplantation to patients with congestive heart failure and specifically to scar tissue (not living tissue) has shown that the cells survive, engraft and form new muscle and they do excrete fatigue resistant proteins similar to the heart muscle protein.” Dr. HJ Duckers, Interventional Cardiologist, Thoraxcenter, Rotterdam discussed the history of the Bioheart trials in Europe to date and added that “the myoblast therapy is at this time point the only stem cell therapy that is making the claim to actually induce neomyogenesis and that is why it deserves our attention.”
Dr. Warren Sherman, Director, Stem Cell Research and Regenerative Medicine, Columbia University Medical Center, discussed the anticipated MARVEL study, “this study, once completed, will be the bench mark and we are all very optimistic. Thomas Povsic, Assistant Professor of Medicine, Duke University Medical Center worked directly with the investigational sites on the MARVEL study and commented on “the enthusiasm by the investigators that were involved in the study to get patients in and the enthusiasm that the patients have to get into this study.”
Bioheart’s latest Phase II/III MARVEL study has undergone interim analysis and although data are not disclosed due to pending publication confidentiality, the panel of experts has reviewed these data and has unanimously and enthusiastically endorsed moving forward to finish the pivotal studies to bring this product to FDA approval based on their review.
Research by these experts and others has shown that myoblasts may have an advantage over other cell types in treating heart failure as they can survive in low oxygen environments (such as the damaged areas of the heart), they are committed to becoming muscle, and they are the only progenitor cell in the human body that normally develop the ability to contract making them more likely to restore contractile function of the damaged heart.
About Bioheart, Inc.
Bioheart, Inc. is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient’s quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell(R), is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. The Company’s pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell(R) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit www.bioheartinc.com.
DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology
July 8, 2009 by biotech-source.com · Leave a Comment
DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biopharmaceutical company, announced today that it has received a European patent which addresses its Lipid Polymer Micelle (LPM(TM)) technology for the improved oral delivery of drugs. The issued European patent, EP 1460992, entitled “Stabilized Reverse Micelle Compositions and Uses Thereof” covers lipid structures (reverse micelles) that promote the intestinal absorption of peptides and other sensitive drugs that cannot otherwise be given orally.
“The issuance of the European patent for LPM(TM) demonstrates the novelty of this drug delivery system and the preclinical results clearly show that it is a competitive system for oral delivery of drugs, especially those biotechnology products derived from synthetic peptide chemistry or recombinant DNA,” said Christopher J. Schaber, PhD, DOR President and CEO. “We also believe that the LPM(TM) system will be applicable to a large number of water-soluble drugs including peptides that are poorly permeable, resulting in increased patient compliance and safety.”
About the LPM(TM) Technology
The LPM(TM) technology is a platform technology that uses reverse micelles stabilized by polymers. Reverse micelles are generally described as a lipid system and are similar to water-in-oil emulsions in that the hydrophilic lipid head groups are directed towards the micelle core, with the hydrophobic tails imbedded in the oil phase. This results in a drug- delivery system that is a thermodynamically stable clear dispersion of the water-soluble drug in the lipid phase. But unlike water-in-oil systems, stabilized reverse micelles do not depend on the presence of other surfactants and are thermodynamically stable. In the LPM(TM) system, water-soluble drugs are contained in the water space in the core of the micelles and are protected against degradation.
DOR anticipates proceeding towards clinical development of an oral form of the peptide hormone drug leuprolide using the LPM(TM) technology. Leuprolide is a synthetic peptide agonist of gonadotropin releasing hormone (GnRh) that is used in treatment of endometriosis in women and prostate cancer in men. In preclinical studies in rats and dogs, DOR has demonstrated that the LPM(TM) technology results in high systemic bioavailability of intestinally absorbed leuprolide. In both animal models, the bioavailability of leuprolide ranged from 20 to 40 percent, compared to 2.2 percent for the control oral solution. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Injectable forms of leuprolide marketed under tradenames such as Lupron(R) and Eligard(R) had worldwide sales of approximately $1.8 billion in 2006. Injectable leuprolide is also widely used in non-cancer indications, such as endometriosis in women (a common condition in which cells normally found in the uterus become implanted in other areas of the body), uterine fibroids in women (noncancerous growths in the uterus) and central precocious puberty in children (a condition causing children to enter puberty too soon). Leuprolide is currently available only in injectable, injectable depot and subcutaneous implant routes of delivery.
LPM(TM) is thought to promote intestinal absorption through the action of the micelles to open up small channels that allow only molecules of a certain dimension to pass through, excluding extremely large molecules, bacteria and viruses. The reverse micelles also structurally prevent the rapid inactivation of peptides by enzymes in the upper gastrointestinal tract. Other sensitive drugs that can be delivered orally with the LPM(TM) system include various classes of drugs such as peptides, nucleic acids and proteins which are degraded in the stomach and small intestine. Corresponding patents in the United States and elsewhere are currently pending.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR’s lead product, orBec(R) (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of hematopoietic cell transplantation. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec(R) for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of DOR201 in radiation enteritis in the second half of 2009. orBec(R) is also currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.
Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR’s biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin, botulinum toxin and anthrax. DOR’s ricin toxin vaccine, RiVax(TM), has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
For further information regarding DOR BioPharma, Inc., please visit the Company’s website at www.dorbiopharma.com.
avVaa World Health Care Products, Inc. Announces That Its DRTV Commercial for Neuroskin(R) Psoriasis Relief Is In Final Stages Of Completion
July 8, 2009 by biotech-source.com · Leave a Comment
avVaa World Health Care Products Inc. (Pink Sheets: AVVH), a global biotechnology company, manufacturer and distributor of nationally branded therapeutic, natural skin and health care products, announced today that avVaa is in the final stages for completion of the Neuroskin(R) Psoriasis Relief Direct Response Television (”DRTV”) commercial.
The Neuroskin(R) Psoriasis Relief will have two cuts of the 120 second DRTV commercial with separate call to actions and toll free numbers. The reasons for two separate DRTV CTA and separate toll free number is that the media test will tell avVaa, what time is best to run the spots, what stations are working the best, what geographical areas is the Company selling into, and most importantly for avVaa, which call to action offer works best, and whether their offer was strong enough on behalf of the product and company.
Ms Farley, President/COO/Co Founder stated, “it is important to understand that doing a media test will tell us about our ROI (Return on Investment) and MER (Media Efficiency Ratio). avVaa may need to do two media tests before going into full launch. The media test month is targeted for August as August is Psoriasis Month.”
Ms Farley goes on to say, “we will be donating a certain dollar value from the sales of the DRTV commercial on the Neuroskin(R) Psoriasis Relief by avVaa to a non profit organization which is the country’s largest organization dedicated to psoriasis research and information. Our target market is the 7.5 million Americans, that’s two out of every 100 Americans that have a form of psoriasis, which there is currently no cure for.
The media test month of August should prove that the DRTV commercials were successful and avVaa World Health Care will then plan for a successful full national launch campaign.
About avVaa World Health Care Products
avVaa World Health Care Products is a global biotechnology company that specializes in effective, all natural, therapeutic skin care products that improve quality of life and well being for consumers. avVaa’s patented European skin care formulas are scientifically registered, FDA-Compliant, and were developed to relieve and treat the symptoms of common skin ailments, including eczema, psoriasis and acne. avVaa is poised to manufacture and market its OTC Neuroskin(r) line of skin care products through mass, food and drug channels in the United States and globally. The Company’s secondary line of equine and pet care related products are already being distributed throughout all of Canada. For more information, visit: www.avvaa.com.
ArborGen and Senesco Announce Wood Quality Results
July 8, 2009 by biotech-source.com · Leave a Comment
ArborGen, LLC, a leader in forest tree improvement technologies, today announced wood quality results from ongoing field trials that are utilizing technology in-licensed from Senesco Technologies, Inc. (NYSE: SNT) (AMEX: SNT) . The two companies had previously announced that trees that incorporate Senesco technology have shown significantly enhanced growth rates in 3-year-old field trials.
Selected trees from the field trials were harvested and their wood chemistry and density was assessed. There were no differences in key economic characteristics of wood, such as lignin, cellulose, and specific gravity, between the trees with the enhanced growth attributes and untreated control trees. This is good news as fast tree growth is often associated with lower wood quality.
“With several years of positive field trials, Senesco’s technology has certainly given us confidence in the consistency of performance of this technology,” said Barbara Wells, Ph.D., president and CEO of ArborGen. “Our collaboration with Senesco continues to produce very promising results that we expect will ultimately add to our portfolio of forestry products.”
Bruce Galton, President and CEO of Senesco, said, “We believe ArborGen’s results represent another step toward the commercial validation of our technology in the hands of our licensing partners. Partnering with companies with ArborGen’s expertise allows for development of our technology for agricultural applications, while our internal research and development remains focused on our near term goal of filing an Investigational New Drug application with the FDA for our ongoing oncology work in multiple myeloma. We believe these results further reaffirm the broad applicability of Senesco’s technology.”
About ArborGen, LLC
ArborGen is a leader in tree improvement and the commercial production of trees. We are dedicated to helping the global forest industry meet the growing demand for wood, pulp & paper, and energy in a more productive and sustainable way. Enabling more wood to be grown on less land helps conserve the world’s native forests in all their beauty, diversity and complexity. With one of the world’s most extensive tree germplasm resources, ArborGen uses both traditional breeding and advanced genetic technologies, to discover and produce high yield seedlings for our customers, allowing our customers to significantly increase the productivity of their forests and manufacturing processes. Our mission is to deliver superior performing trees through innovative science and world class customer service — every tree, every time. For more information, please visit www.arborgen.com.
About Senesco Technologies, Inc.
Senesco Technologies, Inc. is a U.S. biotechnology company, headquartered in New Brunswick, NJ. Senesco has initiated preclinical research to trigger or delay cell death in mammals (apoptosis) to determine if the technology is applicable in human medicine. Accelerating apoptosis may have applications to development of cancer treatments. Delaying apoptosis may have applications to certain inflammatory and ischemic diseases. Senesco takes its name from the scientific term for the aging of plant cells: senescence. Delaying cell breakdown in plants extends freshness after harvesting, while increasing crop yields, plant size and resistance to environmental stress. The Company believes that its technology can be used to develop superior strains of crops without any modification other than delaying natural plant senescence. Senesco has partnered with leading-edge companies engaged in agricultural biotechnology and earns research and development fees for applying its gene-regulating platform technology to enhance its partners’ products.
Applied Biosystems Unveils New Real-Time PCR Assays That Quantify Proteins in Human Cells
July 8, 2009 by biotech-source.com · Leave a Comment
Applied Biosystems, part of Life Technologies Corporation (NASDAQ:LIFE), today announced the introduction of a new line of TaqMan® real-time PCR assays that enable researchers to rapidly detect and quantify proteins in human cell samples. The TaqMan Protein Expression Assays enable researchers to correlate relative levels of specific proteins with cell functions and behaviors, such as different disease conditions, or states of pluripotency or differentiation in stem cells. The initial release of these molecular tools includes assays that enable relative quantification of protein markers for pluripotency from limited quantities of cultured human embryonic stem cells.
These new molecular tools offer researchers a more quantitative, simpler, and more standardized approach to protein analysis of various cell types, especially stem cells, compared to other more complex methods that also require large amounts of cell sample. The new assays detect and quantify proteins by an innovative technology that combines an antibody-oligonucleotide-tagged immunoassay with a TaqMan Assay to generate real-time PCR data for specific proteins present in as little as 10-250 cells.
The initial release of these assays in August will consist of six pre-designed protein expression assays. Four of the assays target stem cell pluripotency markers, and two, target more commonly expressed proteins in a variety of cell types. When combined with Applied Biosystems TaqMan Assays for microRNA and messenger RNA and run on one of its family of real-time PCR systems, they form the life-science industry’s only quantitative protein analysis method that enables researchers to make comparisons of protein and RNA molecular markers identified on the same platform with the same starting samples.
The new assays for targets in stem cells have already been used by a team of scientists at Erasmus University Medical Center in Rotterdam, The Netherlands to quantify protein biomarkers for pluripotency using small quantities of human stem cell and testicular germ cell samples. In a study being presented this week at the International Society for Stem Cell Research (ISSCR) conference in Spain, the scientists used the TaqMan Protein Expression Assays to analyze germ cell tumors and derived cell lines to characterize protein biomarkers for stem cell pluripotency. These kinds of biomarkers can potentially be used in research to identify and characterize malignant cells.
Prof Leendert Looijenga, Department of Pathology, Erasmus University Medical Center
“The development of the TaqMan Protein Expression Assays will result in a significant step forward in the investigation of the biology of many proteins, including those involved in stem cell regulation — both normal and malignant — using limited amounts of material, in a standardized set up.”
Sam Raha, Vice President of Life Technologies’ Genomic Assays Business
“This innovative real-time PCR technology expands our industry-leading line of TaqMan assays for gene expression and genotyping to now include solutions for protein detection and quantitation. Our combined portfolio of TaqMan assays and real-time PCR systems will provide scientists with a more complete picture of the biology of living organisms.”
Additional Resources
TaqMan Protein Expression Assay Workflow Schematic
Poster Presentation from ISSCR
About Applied Biosystems Products
Life Technologies’ Applied Biosystems brand is a global leader in providing innovative, optimized instrument systems and workflows to accelerate academic and clinical research, drug discovery and development, pathogen detection and forensic DNA analysis. Through its Applied Biosystems and Invitrogen brand of reagents, kits and bench-top devices, Life Technologies markets the most comprehensive portfolio of solutions for molecular and cell biology. Applied Biosystems and Invitrogen products are used in nearly every major laboratory in the world. For more information, please visit: www.appliedbiosystems.com and www.invitrogen.com.
About Life Technologies
Life Technologies Corporation (NASDAQ:LIFE) is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics. Life Technologies had sales of more than $3 billion in 2008, employs approximately 9,500 people, has a presence in more than 100 countries, and possesses a rapidly growing intellectual property estate of approximately 3,600 patents and exclusive licenses. Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems Inc. For more information on how we are making a difference please visit our website: www.lifetechnologies.com.
