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Category Archives: Cell Therapy
Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell …
Posted: October 18, 2012 at 2:10 am
WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM).
"There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner.
Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."
"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent
About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.
About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.
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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell ...
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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock
Posted: October 18, 2012 at 12:12 am
NEW YORK, Oct. 17, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").
On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.
"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."
About NeoStem, Inc.
NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.
Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.
For more information on NeoStem, please visit http://www.neostem.com.
Forward-Looking Statements for NeoStem, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock
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Husband testifies wife ‘was looking for a cure’ and found Bonita stem-cell doctor
Posted: October 17, 2012 at 8:11 am
The Grekos hearing is scheduled to resume today. The location is the Collier County Courthouse in room 4-D, according to a case filing Monday.
The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.
Photo by Allie Garza
Zannos Grekos
EAST NAPLES The patient was friends with the mother of Dr. Zannos Grekos, a Bonita Springs cardiologist who performed stem cell therapy on people with debilitating illnesses.
Chemotherapy for breast cancer several years earlier had left the 69-year-old patient, Domenica Fitzgerald, with numbness in her legs. She was unable to walk for more than 10 minutes. She hoped Grekos and his stem cell treatment could help.
"She was looking for a cure. She wanted to get well," her husband, John "Jack" Fitzgerald, testified Tuesday.
A four-day administrative hearing started Tuesday in a Collier County courtroom for a state Department of Health complaint against Grekos. The state says he committed medical malpractice and violated other standards of care when he performed a stem cell treatment on the patient on March 24, 2010. The patient suffered brain damage.
The state is only identifying the patient in its complaint by her initials, D.F. The Daily News learned of her identity by a public records request to the Collier County Medical Examiner's Office of all people who died on April 4, 2010, in the county. That was the day that Fitzgerald died after being taken off life support.
The state last year restricted Grekos' license after her death and ordered him not to do anything with stem cells with other patients. His license was fully suspended earlier this year when the state said he violated the order by treating another patient who also died.
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Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor
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RBCC: Could Stem Cells Be Key to Promising Autism Therapy?
Posted: October 16, 2012 at 11:17 am
NOKOMIS, Fla.--(BUSINESS WIRE)--
Rainbow Coral Corp. (RBCC) subsidiary Rainbow BioSciences will keep a close eye on a new study that could potentially lead to stem cell therapies for children with autism.
Researchers have been given the go-ahead by the FDA to launch a small study evaluating the effectiveness of autism treatments using patients own umbilical cord blood. Thirty children, aged two to seven, will receive injections of their own stem cells from the cord blood banked by their parents at birth.
Scientists will evaluate whether the stem cell therapy helps improve language and behavior in the children. Although the cause of autism is unknown and there is no cure for the disorder, one theory suggests that autism occurs because cell in the brain, known as neurons, are not connecting normally. Its possible that stem cells may address this problem.
RBCC is working to capitalize on the rising demand for effective new stem cell treatments by bringing a potentially game-changing stem cell technology to market. The company is close to a deal with Regenetech to acquire a license to perform cell expansion using that companys Rotary Cell Culture SystemTM, a rotating-wall bioreactor originally developed by NASA.
The rotating-wall bioreactor is capable of multiplying functional, 3-D stem cells for use in a variety of research projects, said RBCC CEO Patrick Brown. Stem cells carry tremendous potential to help researchers develop new treatments and cures for devastating diseases from Parkinsons to Alzheimers and even autism, but much research must be done first. Consequently, were very optimistic about the market potential for this revolutionary bioreactor technology.
RBCC plans to offer the new technology to help kickstart billions of dollars worth of research in an industry currently dominated by Amgen, Inc. (AMGN), Celgene Corporation (CELG), Genzyme Corp. (NASDAQ:GENZ) and Gilead Sciences Inc. (GILD).
For more information on Rainbow BioSciences, please visit http://www.rainbowbiosciences.com/investors.html.
About Rainbow BioSciences
Rainbow BioSciences, LLC, is a wholly owned subsidiary of Rainbow Coral Corp. (OTCBB:RBCC). The company continually seeks out new partnerships with biotechnology developers to deliver profitable new medical technologies and innovations. For more information on our growth-oriented business initiatives, please visit our website at [http://www.RainbowBioSciences.com]. For investment information and performance data on the company, please visit http://www.RainbowBioSciences.com/investors.html.
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RBCC: Could Stem Cells Be Key to Promising Autism Therapy?
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Significant Recovery Of Motor And Neurological Functions In Ischemic Stroke Rats With Neuralstem NSI-566 Cells
Posted: October 15, 2012 at 7:14 pm
ROCKVILLE, Md., Oct. 15, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that data on Neuralstem's NSI-566 spinal cord-derived neural stem cell line in a rat model of ischemic stroke was presented in a poster, "Histopathological Assessment of Adult Ischemic Rat Brains after 4 Weeks of Intracerebral Transplantation of NSI-566RSC Cell Line," at The Society for Neurosciences Annual Meeting (http://www.sfn.org/AM2012/). This study was conducted independently in the laboratory of Dr. Cesar Borlongan, who is the director at the Center of Excellence for Aging and Brain Repair at the University of South Florida College of Medicine. Post-mortem histology was conducted in collaboration with Neuralstem. Rats that suffered ischemic stroke by middle cerebral artery occlusion, were transplanted 7 days post-stroke with increasing doses of NSI-566 into the stroke area. The animals were followed for safety and behavioral response for 56 days post-transplantation. Researchers reported Saturday that there was significant improvement in both motor and neurological tests in the stem cell-treated rats. There were significant dose-dependent differences in the behavioral improvement across treatment groups at post-transplantation periods, with the highest dose showing the most significant improvement in both motor and neurological tests. Similarly, there were significant differences in the behavioral performance among treatment groups at post-transplantation periods, with the most significant improvement in both motor and neurological tests seen at day 56 post-transplantation.
(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )
"This study was designed to evaluate the potential therapeutic value of intracerbral dosing of human neural stem cells (NSI-566, supplied by Neuralstem) in an animal model of adult ischemic stroke," said Cesar V. Borlongan, Ph.D., University of South Florida College of Medicine, and the lead study author. "The results are very clear. The recovery of motor and neurological tests demonstrated by high-dose transplanted stroke animals was significantly better throughout the 56-day study period compared to vehicle-infused stroke animals, or low-dosed animals. In addition, there was stable improvement in the high-dose animals, and they showed a trend of better improvement over time."
A separate poster, "Survival and Differentiation of Human Neural Stem Cells (NSI-566RSC) After Grafting into Ischemia-Injured Porcine Brain," was also presented on Saturday. This study was independently carried out by Dr. Martin Marsala and his colleagues. Dr. Marsala is a professor and the head of the Neuroregeneration Laboratory at University of California San Diego and also a member of the Sanford Consortium for Regenerative Medicine. In this study, the same stem cells were transplanted into the brains of pigs that received an ischemic stroke on one side of the brain. 8-9 weeks after the ischemic event, which models chronic stroke in humans, feasibility and safety of escalating cell doses and injections were assessed. Body temperature, behavior, muscle tone and coordination, sensory function, food consumption, defecation, and micturition were monitored at least twice daily for the first 7 days, and once weekly thereafter, until termination. Up to 12 million cells in 25 cell injection deposits via 5 cannula penetrations were shown to be safe, which closely mimics the intended clinical route and method of delivery in future human clinical trials. At 6 weeks post-transplantation, there were no complications from the cell transplantation method or the cells. All animals recovered and showed progressive improvement with no distinction. All treated animals showed effective engraftment and neuronal maturation with extensive axonal projections. These data support the application of NSI-566RSC cell line to be transplanted into a chronic stage of previously ischemia-injured brain for treatment of motor deficits resulting from stroke.
"Our study was designed to evaluate the potential value of Neuralstem's cells in a chronic model of ischemic stroke and in a species that allowed for the use of human scale transplantation tools and dosing," said Martin Marsala, MD, at the University of California at San Diego Medical School, and the lead study author of the porcine study. "We have demonstrated clearly that both the route of administration and the cells are safe and well tolerated and that the cells survived and differentiated into mature neurons in the host brain tissue."
"We have demonstrated safety and efficacy of NSI-566RSC in a subacute model of ischemic stroke in rats and feasibility and safety in a chronic model of ischemic stroke in mini-pigs," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer. "Together, these two studies demonstrate strong proof of principle data that our NSI-566 cells are ready to go into humans to treat paralysis in stroke patients."
Neuralstem has recently completed a Phase I trial testing the safety of NSI-566 in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and has been approved to initiate a human clinical trial in ischemic stroke in China, through its subsidiary, Suzhou Neuralstem.
About Neuralstem
Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently treated the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in spinal cord injury.
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State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday
Posted: October 15, 2012 at 7:14 pm
The Grekos hearing is scheduled to begin at 9 a.m. Tuesday in the Martin Luther King, Jr. Administration Building, room 1-140A, 5775 Osceola Trail, Naples. It is scheduled for four days.
Photo by Allie Garza
Zannos Grekos
BONITA SPRINGS Bonita Springs physician Zannos Grekos, whose license is in jeopardy for controversial stem cell therapy, is getting his day before a judge.
Barring a last-minute delay or settlement, an administrative hearing is scheduled to begin Tuesday in Naples for the 47-year-old. He is fighting to get his license back in good standing from a suspension order, while the state Department of Health is pursuing more discipline and potentially revocation of his license.
Trained as a cardiologist, he's been licensed in Florida since 1996.
The trial-like proceeding, without a jury, is scheduled for four days before an administrative law judge. The proceeding is open to the public. The case against Grekos has garnered considerable media attention, including CNN and inquiries from European media.
A Texas father, Jimmy Bell, will be tracking what happens. Last year, he paid $57,000 upfront for his 5-year-old son, Jason, to undergo stem cell therapy to fight pulmonary hypertension. Despite pleas that his boy was weakening by the day, the treatment was never scheduled and Jason died. Bell received a $10,000 refund.
"He's taking advantage of people and it's more for personal gain," Bell said. "I'd like to see that stopped."
The hearing has been rescheduled numerous times since the state issued an emergency restriction against Grekos in February 2011. Authorities restricted his license and told him not to do any treatment with patients which involve bone marrow or stem cells.
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State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday
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Ricky Reyes to help set up Fresh Cell Therapy clinic in the Philippines
Posted: October 14, 2012 at 8:14 am
Hanggang ngayon ay usap-usapan pa rin ang Fresh Cell Therapy (FCT) o mas kilala natin bilang stem cell therapy lalo nat marami nang celebrities ang nahihikayat na sumailalim sa naturang medical procedure na nagpo-promote ng anti-aging at nakatutulong para labanan ang ilang serious health conditions.
Isa na nga rito ang sikat na hairstylist, beauty expert, philanthropist, businessman, at TV host na si Ricky Reyes o mas kilala bilang si Mother Ricky.
Sumailalim si Mother Ricky sa FCT noong Hunyo ng taong ito at ngayon nga ay ine-enjoy niya ang benepisyo nito sa kanyang kalusugan.
The fact that my arthritis is gone, Im very, very happy and Im thankful to Bobby [Kittichaiwong, Villa Medica CEO). And its just a two-shot on my back, gone instantly. You know, yung quality of life mo na hindi ka aray-aray-aray?
Tapos nagpunta ako sa Germany last June and its such a beautiful place. We even had meron ka pang tour sa Paris [France]. Very nice place, sabi ni Mother Ricky.
Nakausap ng PEP.ph (Philippine Entertainment Portal) si Mother Ricky sa presscon ng Villa Medica tungkol sa FCT na ginanap kaninang tanghali, Oktubre 13, sa Crowne Plaza sa Ortigas, Pasig City.
Hindi rin daw niya maitatanggi ang kabutihang naidulot ng FCT sa kanyang ina, na sumailalim din sa naturang therapy.
Oo naman, with my experience with my mom. Dati nakatungo na, ngayon nakataas na yung leeg na ganyan, paglalarawan pa ni Mother Ricky tungkol sa nagawa ng FCT sa kanyang ina.
Nai-stretch na yung mga kamay. Isang malaking utang na loob ko yun kay Bobby. It is a Christmas gift of Bobby to me to cure my mom.
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Ricky Reyes to help set up Fresh Cell Therapy clinic in the Philippines
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Ricky Reyes to help set up Fresh Cell Therapy clinic in the Philippines
Posted: October 13, 2012 at 2:15 pm
Hanggang ngayon ay usap-usapan pa rin ang Fresh Cell Therapy (FCT) o mas kilala natin bilang stem cell therapy lalo nat marami nang celebrities ang nahihikayat na sumailalim sa naturang medical procedure na nagpo-promote ng anti-aging at nakatutulong para labanan ang ilang serious health conditions.
Isa na nga rito ang sikat na hairstylist, beauty expert, philanthropist, businessman, at TV host na si Ricky Reyes o mas kilala bilang si Mother Ricky.
Sumailalim si Mother Ricky sa FCT noong Hunyo ng taong ito at ngayon nga ay ine-enjoy niya ang benepisyo nito sa kanyang kalusugan.
The fact that my arthritis is gone, Im very, very happy and Im thankful to Bobby [Kittichaiwong, Villa Medica CEO). And its just a two-shot on my back, gone instantly. You know, yung quality of life mo na hindi ka aray-aray-aray?
Tapos nagpunta ako sa Germany last June and its such a beautiful place. We even had meron ka pang tour sa Paris [France]. Very nice place, sabi ni Mother Ricky.
Nakausap ng PEP.ph (Philippine Entertainment Portal) si Mother Ricky sa presscon ng Villa Medica tungkol sa FCT na ginanap kaninang tanghali, Oktubre 13, sa Crowne Plaza sa Ortigas, Pasig City.
Hindi rin daw niya maitatanggi ang kabutihang naidulot ng FCT sa kanyang ina, na sumailalim din sa naturang therapy.
Oo naman, with my experience with my mom. Dati nakatungo na, ngayon nakataas na yung leeg na ganyan, paglalarawan pa ni Mother Ricky tungkol sa nagawa ng FCT sa kanyang ina.
Nai-stretch na yung mga kamay. Isang malaking utang na loob ko yun kay Bobby. It is a Christmas gift of Bobby to me to cure my mom.
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Ricky Reyes to help set up Fresh Cell Therapy clinic in the Philippines
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Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough
Posted: October 11, 2012 at 2:20 pm
NEW YORK, NY--(Marketwire - Oct 11, 2012) - Immunovative, Inc. ("IMUN" or the "Company") ( OTCBB : IMUN ) has today announced that Immunovative Therapies, Ltd. ("ITL") has been granted a U.S. Patent entitled "METHOD FOR ALLOGENEIC CELL THERAPY," which was issued September 25, 2012, under Patent No. 8,273,377. Foreign versions of this patent are pending around the world. This patent covers the proprietary method that utilizes immune cells from a normal donor to elicit an anti-tumor mechanism that mimics the Graft vs. Tumor (GVT) effect of non-myeloablative allogeneic stem cell transplants ("Mini-Transplant") without the toxicity of Graft vs. Host Disease (GVHD). Harnessing the power of the immune system to treat cancer and infectious disease has long been the goal of physicians and scientists. Unfortunately, cancer vaccines and cell immunotherapy methods have had difficulties in translating the promise of immune control into effect treatments. The most effective anti-cancer mechanism ever discovered is the GVT immune response that occurs after Mini-Transplant procedures. This mechanism can completely destroy chemotherapy-resistant metastatic cancers. Unfortunately, the clinical use of the GVT effect is severely limited due to extreme toxicity of an intimately related GVHD effect. Mini-Transplants are thus only widely used in advanced cases of leukemia, even though the GVT effect has been shown capable of killing many types of solid tumors. The separation of the beneficial GVT effect from the devastating GVHD toxicity has long been the goal of stem cell transplant scientists and is the subject of extensive research around the world.
ITL is believed to be the first to develop an immunotherapy drug product (AlloStim) which enables the harnessing of the power of the GVT mechanism without GVHD side effects. ITL calls the mechanism which enables immune-mediated tumor destruction without GVHD toxicity the "Mirror Effect." The "Mirror Effect" mechanism represents a major breakthrough for treatment of cancer and infectious disease. Early human clinical trials have produced evidence of this technology's capability to stimulate the immune systems of heavily pre-treated metastatic cancer patients to kill widely disseminated metastatic cancers. A potentially pivotal, double-blind, placebo-controlled Phase II/III clinical trial in metastatic breast cancer is being prepared to document these effects in a controlled setting and determine if the immune-mediated tumor debulking provides patients with a survival advantage. This issued US Patent covers the use of intentionally mismatched, activated immune cells for treatment of cancer and infectious diseases. The patent discloses the concepts and methods related to ITL's proprietary "Mirror Effect" technology and describes its lead immunotherapy drug candidate "AlloStim." This patent also describes how AlloStim eliminates the need for a matched tissue donor and chemotherapy pre-conditioning for patients that require a bone marrow or stem cell transplant.
The newly issued patent is part of an intellectual property portfolio from ITL that includes 11 issued patents and numerous patent applications, to which IMUN has exclusive rights in the US and the rest of the world. The licensed patents cover compositions, methods of production, formulation, distribution and uses for treatment of all types of cancer and infectious diseases.
Seth M. Shaw, CEO of IMUN, stated: "The separation of the beneficial GVT effect from the devastating GVHD toxicity has been called the 'Holy Grail' of transplant research. ITL is the first to accomplish this significant scientific milestone. We are confident that ITL's extensive Intellectual Property ("IP") portfolio will provide our products with long-term market exclusivity. This patent is an important component of our growing IP estate, as the allowed claim language is very broad. We are now the exclusive allogeneic cell therapy company in the world. Our strong patent portfolio will now allow us to pursue opportunities for partnering and sub-licensing by indication and territory around the world."
Dr. Michael Har-Noy, CEO, founder of ITL and inventor of the "Mirror Effect" technology stated: "Our patent portfolio is a valuable asset as it not only protects our AlloStim and AlloVax product candidates, but also provides protection of the unique mechanism of action that enables these products to have such powerful potential to debulk treatment-resistant metastatic disease. We are continuing to invest in research activities to improve our current product candidates and develop new products and further expand our patent portfolio. With protection of the novel mechanism of action, ITL and IMUN have the basis for development of a new industry based on powerful, non-toxic immunotherapy products that can work where all current treatment options have failed."
About Immunovative, Inc.: On December 12th, 2011, Immunovative, Inc. ("IMUN") signed an exclusive License Agreement (the "License Agreement") with Immunovative Therapies, Ltd. ("ITL"). Under the terms of the License Agreement, IMUN has been granted an exclusive, worldwide license to commercialize any products covered under ITL's current issued and pending patent application portfolio, as well as the rights to any future patent applications, including improvements or modifications to the existing applications and any corresponding improvements or new versions of the existing products. Please visit IMUN's website at http://www.imun.com.
About Immunovative Therapies, Ltd.:
Immunovative Therapies, Ltd. is an Israeli biopharmaceutical company that was founded in May 2004 with financial support from the Israeli Office of the Chief Scientist. ITL is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israeli technological incubator program. The company was the Misgav Venture Accelerator's candidate for the prize for the outstanding incubator project of 2006, awarded by the Office of the Chief Scientist. ITL specializes in the development of novel immunotherapy drug products that incorporate living immune cells as the active ingredients for treatment of cancer and infectious disease. Please visit ITL's website at: http://www.immunovative.co.il
DISCLAIMER: Forward-Looking Statements: Except for statements of historical fact, this news release contains certain "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995, including, without limitation, expectations, beliefs, plans and objectives regarding the development, use and marketability of products. Such forward-looking statements are based on present circumstances and on IMUN's predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, and are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results expressed or implied by such forward-looking statements. Such factors include general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to fund operations and other factors over which IMUN has little or no control. Such forward-looking statements are made only as of the date of this release, and IMUN assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. Risks, uncertainties and other factors are discussed in documents filed from time to time by IMUN with the Securities and Exchange Commission.
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Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough
Posted in Cell Therapy
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Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough
Posted: October 11, 2012 at 2:17 pm
NEW YORK, NY--(Marketwire - Oct 11, 2012) - Immunovative, Inc. ("IMUN" or the "Company") ( OTCBB : IMUN ) has today announced that Immunovative Therapies, Ltd. ("ITL") has been granted a U.S. Patent entitled "METHOD FOR ALLOGENEIC CELL THERAPY," which was issued September 25, 2012, under Patent No. 8,273,377. Foreign versions of this patent are pending around the world. This patent covers the proprietary method that utilizes immune cells from a normal donor to elicit an anti-tumor mechanism that mimics the Graft vs. Tumor (GVT) effect of non-myeloablative allogeneic stem cell transplants ("Mini-Transplant") without the toxicity of Graft vs. Host Disease (GVHD). Harnessing the power of the immune system to treat cancer and infectious disease has long been the goal of physicians and scientists. Unfortunately, cancer vaccines and cell immunotherapy methods have had difficulties in translating the promise of immune control into effect treatments. The most effective anti-cancer mechanism ever discovered is the GVT immune response that occurs after Mini-Transplant procedures. This mechanism can completely destroy chemotherapy-resistant metastatic cancers. Unfortunately, the clinical use of the GVT effect is severely limited due to extreme toxicity of an intimately related GVHD effect. Mini-Transplants are thus only widely used in advanced cases of leukemia, even though the GVT effect has been shown capable of killing many types of solid tumors. The separation of the beneficial GVT effect from the devastating GVHD toxicity has long been the goal of stem cell transplant scientists and is the subject of extensive research around the world.
ITL is believed to be the first to develop an immunotherapy drug product (AlloStim) which enables the harnessing of the power of the GVT mechanism without GVHD side effects. ITL calls the mechanism which enables immune-mediated tumor destruction without GVHD toxicity the "Mirror Effect." The "Mirror Effect" mechanism represents a major breakthrough for treatment of cancer and infectious disease. Early human clinical trials have produced evidence of this technology's capability to stimulate the immune systems of heavily pre-treated metastatic cancer patients to kill widely disseminated metastatic cancers. A potentially pivotal, double-blind, placebo-controlled Phase II/III clinical trial in metastatic breast cancer is being prepared to document these effects in a controlled setting and determine if the immune-mediated tumor debulking provides patients with a survival advantage. This issued US Patent covers the use of intentionally mismatched, activated immune cells for treatment of cancer and infectious diseases. The patent discloses the concepts and methods related to ITL's proprietary "Mirror Effect" technology and describes its lead immunotherapy drug candidate "AlloStim." This patent also describes how AlloStim eliminates the need for a matched tissue donor and chemotherapy pre-conditioning for patients that require a bone marrow or stem cell transplant.
The newly issued patent is part of an intellectual property portfolio from ITL that includes 11 issued patents and numerous patent applications, to which IMUN has exclusive rights in the US and the rest of the world. The licensed patents cover compositions, methods of production, formulation, distribution and uses for treatment of all types of cancer and infectious diseases.
Seth M. Shaw, CEO of IMUN, stated: "The separation of the beneficial GVT effect from the devastating GVHD toxicity has been called the 'Holy Grail' of transplant research. ITL is the first to accomplish this significant scientific milestone. We are confident that ITL's extensive Intellectual Property ("IP") portfolio will provide our products with long-term market exclusivity. This patent is an important component of our growing IP estate, as the allowed claim language is very broad. We are now the exclusive allogeneic cell therapy company in the world. Our strong patent portfolio will now allow us to pursue opportunities for partnering and sub-licensing by indication and territory around the world."
Dr. Michael Har-Noy, CEO, founder of ITL and inventor of the "Mirror Effect" technology stated: "Our patent portfolio is a valuable asset as it not only protects our AlloStim and AlloVax product candidates, but also provides protection of the unique mechanism of action that enables these products to have such powerful potential to debulk treatment-resistant metastatic disease. We are continuing to invest in research activities to improve our current product candidates and develop new products and further expand our patent portfolio. With protection of the novel mechanism of action, ITL and IMUN have the basis for development of a new industry based on powerful, non-toxic immunotherapy products that can work where all current treatment options have failed."
About Immunovative, Inc.: On December 12th, 2011, Immunovative, Inc. ("IMUN") signed an exclusive License Agreement (the "License Agreement") with Immunovative Therapies, Ltd. ("ITL"). Under the terms of the License Agreement, IMUN has been granted an exclusive, worldwide license to commercialize any products covered under ITL's current issued and pending patent application portfolio, as well as the rights to any future patent applications, including improvements or modifications to the existing applications and any corresponding improvements or new versions of the existing products. Please visit IMUN's website at http://www.imun.com.
About Immunovative Therapies, Ltd.:
Immunovative Therapies, Ltd. is an Israeli biopharmaceutical company that was founded in May 2004 with financial support from the Israeli Office of the Chief Scientist. ITL is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israeli technological incubator program. The company was the Misgav Venture Accelerator's candidate for the prize for the outstanding incubator project of 2006, awarded by the Office of the Chief Scientist. ITL specializes in the development of novel immunotherapy drug products that incorporate living immune cells as the active ingredients for treatment of cancer and infectious disease. Please visit ITL's website at: http://www.immunovative.co.il
DISCLAIMER: Forward-Looking Statements: Except for statements of historical fact, this news release contains certain "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995, including, without limitation, expectations, beliefs, plans and objectives regarding the development, use and marketability of products. Such forward-looking statements are based on present circumstances and on IMUN's predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, and are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results expressed or implied by such forward-looking statements. Such factors include general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to fund operations and other factors over which IMUN has little or no control. Such forward-looking statements are made only as of the date of this release, and IMUN assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. Risks, uncertainties and other factors are discussed in documents filed from time to time by IMUN with the Securities and Exchange Commission.
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Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough
Posted in Cell Therapy
Comments Off on Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough