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Planda Biotechnology Changing the Future of Green Tea with Technology Used in Origine 8 Capsules – Markets Insider

Posted: May 11, 2017 at 12:42 pm

NEW YORK, NY--(Marketwired - May 10, 2017) - Planda Biotechnology's (OTCQB: PLPL) Origine 8 capsules could be the future of green tea. Drinking a cup of green tea tastes great, but unless the eight catechins from the green tea plant are getting into your blood stream and staying there long enough to offer a therapeutic dose, it's really just a tasty cup of green tea and nothing more. Planda has already proven in clinical studies that its green tea extract, Phytofare Catechin Complex, is highly bioavailable, which in Planda's case means that all eight catechins of the green tea extract are getting into the blood stream and staying there for 24 hours.

Planda isn't satisfied with just delivering a potent green tea extract; instead, it has taken the delivery of Phytofare deep into the body a step further. Basically, Origine 8 capsules use an advanced liposome technology to move Phytofare around inside the human body in a protective bubble. Liposomes are tiny nano-sized bubbles with an outer shell made up of healthy lipids and a hollow aqueous center that Planda fills with Phytofare. The outer layer of the liposome protects the green tea extract from gastric juices and liver enzymes, and clinical studies are showing that liposomes support the absorption of nutrition and have excellent efficacy.

The company starts with its high-quality extract Phytofare, and then further enhances the product by using this technology for improved delivery on the cellular level.

Liposomes work by initially protecting the payload (Phytofare) from the harsh acidic environment of the stomach. Once past the stomach, Phytofare is delivered where needed by absorption through one of the many mechanisms available to liposomes. This higher absorption of nutrition allows its full benefit to be realized. An added advantage of liposomes is increased circulation time of Phytofare, which allows for a longer active life and benefit inside the body.

According to Planda, Origine 8 uses the only known Good Manufacturing Practices (GMP) and registered liposome-manufacturing facility in the world. In the case of the liposome used in the production of Origine 8, phosphatidylcholine is used and extracted from Non-GMO sunflower, the liposome itself has the added benefit of becoming nutrition for the liver, brain, mitochondria, eyes, and the most essential cells in the human body.

Planda calls it a "complete green tea extract" and they state that it's the first and only green tea extract to offer complete catechin absorption. Planda offers all of this in the convenience of a single capsule per day. And, if one capsule per day can deliver a highly bioavailable and protected green tea extract throughout the body, then the days of countless cups of green tea, which may offer no effect at all, may be over. After all, we know today that it's not what you consume but what you absorb that is the most important factor when choosing a product to improve your health.

About Stock Market Media Group

Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles.

We may from time to time include our own opinions about our featured companies, their businesses, markets and opportunities. Any opinions we may offer are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers and viewers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any company are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: http://www.sec.gov. We also recommend as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.

We are not a registered broker, dealer, analyst, or adviser. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications are not a recommendation to buy or sell a security.

Section 17(b) of the 1933 Securities and Exchange Act requires publishers who distribute information about publicly traded securities for compensation, to disclose who paid them, the amount, and the type of payment. In order to be in full compliance with the Securities Act of 1933, Section 17(b), we are disclosing that SMMG is compensated $5,000 per month by Plandai Biotechnology for content development. Neither SMMG nor anyone associated with it owns shares in PLPL.

For more information: http://www.stockmarketmediagroup.com.

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Puma Biotechnology Reports First Quarter 2017 Financial Results – Business Wire (press release)

Posted: May 11, 2017 at 12:42 pm

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the first quarter ended March 31, 2017.

Unless otherwise stated, all comparisons are for the first quarter 2017 compared to the first quarter 2016.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $72.9 million, or $1.97 per share, for the first quarter of 2017, compared to a net loss applicable to common stock of $71.0 million, or $2.19 per share, for the first quarter of 2016.

Non-GAAP adjusted net loss was $43.1 million, or $1.16 per share, for the first quarter of 2017, compared to non-GAAP adjusted net loss of $41.5 million, or $1.28 per share, for the first quarter of 2016. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2017 was $36.0 million. At March 31, 2017, Puma had cash and cash equivalents of $105.1 million and marketable securities of $88.9 million, compared to cash and cash equivalents of $194.5 million and marketable securities of $35.0 million at December 31, 2016.

We made significant progress with our lead investigational drug, neratinib, during the first quarter of 2017, said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. We look forward to continuing to work with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as they review our New Drug Application (NDA) and Marketing Authorization Application (MAA)filings, respectively, and we look forward to presenting the data on neratinib at the upcoming FDA Oncologic Drugs Advisory Committee on May 24th.

Data on neratinib was also presented at the 2017 American Association for Cancer Research Annual Meeting in April which included data on the use of antidiarrheal prophylaxis to reduce the diarrhea with neratinib in the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy (CONTROL trial). There was also clinical data presented on neratinib in the treatment of patients who have solid tumors with activating HER2 or HER3 mutations (SUMMIT trial). Additional data was also presented on the combination of T-DM1 and neratinib in patients with HER2 positive metastatic breast cancer (MBC) that has previously been treated with pertuzumab and trastuzumab. We look forward to continuing to achieve our objectives and believe that Puma is very well-positioned to build value for our shareholders.

Mr. Auerbach added, During 2017, we anticipate the following key milestones with neratinib: (i) reporting data from the Phase III trial in third-line HER2-positive MBC patients in the second quarter of 2017; (ii) reporting data in the second quarter of 2017 from the TBCRC-022 Phase II trial of neratinib plus capecitabine in HER2-positive MBC patients with brain metastases; (iii) reporting final 5-year disease free survival (DFS) data during the second quarter of 2017 from the ExteNET Phase III trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer; and (iv) announcing regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer in the third quarter of 2017.

Operating Expenses

Operating expenses were $73.2 million for the first quarter of 2017, compared to $71.2 million for the first quarter of 2016.

General and Administrative Expenses:

General and administrative expenses were $18.4 million for the first quarter of 2017, compared to $11.0 million for the first quarter of 2016. The approximately $7.4 million increase resulted primarily from increases of approximately $1.4 million for stock-based compensation, $3.9 million for professional fees, $1.3 million for payroll and related costs, and $0.5 million for facility and equipment costs. These increases reflect overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $54.8 million for the first quarter of 2017, compared to $60.2 million for the first quarter of 2016. The approximately $5.4 million decrease resulted primarily from decreases of approximately $1.1 million for stock-based compensation and $5.0 million for clinical trial expenses, partially offset by an increase of $0.6 million for consultants and contractors. For our existing clinical trials, we expect R&D expenses to decrease in subsequent quarters as clinical trials wind down.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential announcement of regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer and the Companys clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

Non-GAAP Financial Measures

In addition to operating results as calculated in accordance with generally accepted accounting principles, or GAAP, the Company uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents the Companys net loss and net loss per share calculated in accordance with GAAP and as adjusted to remove the impact of employee stock-based compensation. For the three months ended March 31, 2017, stock-based compensation represented approximately 40.9% of net loss. Although net loss is important to measure financial performance, the Company currently places an emphasis on cash burn and, more specifically, cash used in operations. Stock-based compensation appears in GAAP net loss but is removed from net loss to arrive at cash used in operations on the statement of cash flows. Due to its noncash nature, the Company believes these non-GAAP measures enhance understanding of financial performance, are more indicative of operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

(1)

To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.

(2)

To reflect a non-cash charge to operating expense for Research and Development stock-based compensation.

(3)

Non-GAAP adjusted net loss per share was calculated based on 36,931,167 and 32,478,408 weighted average common shares outstanding for the three months ended March 31, 2017 and 2016, respectively.

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INTERNATIONAL REGENERATIVE MEDICINE COMMUNITY TO … – EconoTimes

Posted: May 11, 2017 at 12:42 pm

INTERNATIONAL REGENERATIVE MEDICINE COMMUNITY TO CONVENE FOR 13TH WORLD STEM CELL SUMMIT IN MIAMI, JANUARY 2018

The 13ththWorld Stem Cell Summit http://www.worldstemcellsummit.com is taking place January 23-26, 2018 at the Hyatt Regency Miami. Produced by the nonprofit Regenerative Medicine Foundation (RMF), the event is the global ecosystem meeting for advanced therapies; fostering public understanding, promoting positive policy initiatives and collaborations.

The World Stem Cell Summit will be co-located with the fields premier industry partnering event, Phacilitate Leaders Forum, Cell & Gene Therapy World and Immunotherapy World.

In addition to compelling keynotes, plenary and focus sessions, thediverse four-day program includesexpert lunch roundtables; a centrally located Expo packed with innovators in industry, academia and government; a poster forum showcasing science and policy research; the galaStem Cell Action Awards Dinnerhttp://regmedfoundation.org/awards/; as well as many exclusive networking and partnering opportunities.

RMF Executive Director Bernard Siegel, founder and co-chair of the Summit said, We are proud to select Miami to be our host for the next World Stem Cell Summit. Miami is often referred to as the 'City of the Future' and in 2018 it will be the center of the stem cell universe. Its the perfect venue for Summit attendees to gain knowledge, network and collect opportunities to advance their goals, in a superlative, cosmopolitan setting.

ABOUT RMFRegenerative Medicine Foundation is dedicated to accelerating regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honoring leaders through the Stem Cell Action Awards http://worldstemcellsummit.com/stem-cell-action-awards/, publishing the World Stem Cell Report and RegMed Newsletter, organizing educational initiatives such as the upcoming Regenerative Medicine Essentials Course http://www.wakehealth.edu/Research/WFIRM/RMEssentials/Regenerative-Medicine-Essentials.htm and fostering strategic collaborations.

For more information about RMF, visitwww.regmedfoundation.orgor contact Bernard Siegel directly at Bernard@regmedfoundation.org.

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A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/64ef8cd8-84a3-4130-8a8f-f1e020eaeba3

Human Life Could Be Extended Indefinitely, Study Suggests

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Do vegetarians live longer? Probably, but not because they're vegetarian

Could a contraceptive app be as good as the pill?

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These Cells Are Engineered to Be Controlled by a Smartphone – Singularity Hub

Posted: May 11, 2017 at 12:42 pm

To Dr. Mark Gomelsky, a professor at the University of Wyoming, genetically engineered therapeutic cells are like troops on a mission.

The first act is training. Using genetic editing tools such as CRISPR, scientists can train a patients own cells to specifically recognize and attack a variety of enemies, including rogue tumor soldiers and HIV terrorists.

Then comes the incursion. Engineered cells are surgically implanted to the target site, where theyre left to immediately carry out the mission. The problem, says Gomelsky, is adding a command center that could coordinate their activities in real time according to the developing situation, such as telling cells when to activate and when to stop.

The problem has been figuring out a way to bundle a command system with the cellular implants, so that control signals come from within the body. Now, thanks to a new study published in Science Translational Medicine, were one step closer to smart cell therapies, where the command center forms a single closed-loop unit with the engineered soldiers.

In an elegant feat of synthetic biology, a team of Chinese scientists married optogenetics with cellular engineering, generating live cells that can release insulin when bathed under red light.

The cells were then embedded with tiny LED lights inside a hydrogel and transplanted under the skin of diabetic mice. Andget thisthe entire system was controlled with a custom Android app, which remotely turns on the implanted LEDs and activates insulin-producing cells based on the level of circulating blood sugar levels.

After about four hours of light each day, the diabetic mice showed stabilized blood sugar and normal insulin production for over two weeks.

According to lead author Dr. Haifeng Ye at East China Normal University in Shanghai, the goal is to engineer a smart circuit that can sense, monitor and profile insulin levels in the bloodstream, 24 hours a day, using only a smartphone.

And thats just the beginning. These remote-controlled cells offer proof-of-concept evidence that cell-based semiautomatic therapies are possible. This could pave the way for a new era of personalized, digitized and globalized precision medicine, the authors say.

Controlling a cells activity is hard. Drugs are a common method, but as anyone whos ever taken an Advil for a blaring headache can attest to, drugs have a significant onset time lag.

So when scientists discovered that they could precisely control the activity of mammalian cells with light, the field of optogenetics took off like a rocket launcher.

Heres how it works: most of our cells dont usually respond to light, but those in algae do. Algae have several types of light-activated proteins that sit on their membranes, and in response to certain wavelengths of light, these proteins open up like a canal, allowing ions and molecules from outside the cell to flow in. Depending on what those molecules are, this either activates or inhibits the cell.

About a decade ago, scientists realized they could pluck these light-responsive proteins channelrhodopsins from algae, and insert them into mammalian cells. The result? Depending on the cell type, optogenetics can reverse blindness, restore heart rhythms, incept memories into nave mice, drive satiated mice to binge eat or turn on their predatory instincts.

Without doubt, optogenetics is powerful. But because scientists need to use gene therapy to insert channelrhodopsin into cells, translating the method to humans has been tough (although clinical trials are in the works).

This is where cell therapy comes in. Rather than trying to insert a gene into cells inside the body, its much easier to tweak a cells wiring in the lab before transplanting them. Thats the approach that Ye and team took for their smart insulin-pumping cells.

The team first engineered a multi-modular protein, so that it responded to far-red light by activating the genes that produce insulin. Unlike previous generations of light-sensing proteins that were leaky, this new construct had very low background activity in the dark.

To see if the circuit worked, the scientist embedded the cells with tiny biocompatible LED lights into a hydrogel and implanted them under the skin of diabetic mice. Then, he used an external transmitting coil to turn on LEDs through electromagnetic induction and voilainsulin in the bloodstream.

Once the basic system worked, the team went on to engineer a command center. Ye credited his inspiration to the SmartHome project, which seeks to create wireless homes furnished with smartphone-regulated electrical appliances like the Nest thermometer.

At the heart of their SmartController system is a home server box that contains a microprocessor unit chip and a WiFi-powered data receiver unit. To measure blood sugar levels, the team designed a custom digital glucometer that can transmit data to an Android app using Bluetooth. The app relays the glucose measurements to the control box, where it gets analyzed in real-time to control the magnetic transmitting coil.

If blood sugar levels are abnormally high, for example, the controller activates the electromagnetic field generator, which in turn switches on the implanted LED lights.

This triggers cells to release just enough insulin to revert blood sugar levels back to normal without causing low blood sugar symptoms.

We programmed the microcontroller chip to automatically translate blood sugar thresholds into different LED illumination strengths, which allows fully self-sufficient activation of antidiabetic cells based on blood sugar levels, the authors say.

The entire process can be tracked through the app interface, so that doctors could easily intervene in case of unforeseeable errors.

The whole process takes about two hours for sky-high blood sugar levels to return to non-diabetic levels. Once there, the system steadily maintained normal blood sugar levels for 15 days with no observable side effects, all without outside intervention.

This exciting accomplishment is a tribute to an ambitious but careful system design, rigorous optimization and meticulous testing, says Gomelsky, who was not involved in the study.

The current rendition of SmartController is only semiautomatic, in that the team has to manually draw blood from the diabetic mice to feed to the glucometer.

This is easy to tacklescientists just have to replace the glucometer with a continuous glucose monitor, implanted inside the body to provide continuous data to the smartphone app around the clock.

A tad trickier is the power problem. For the transmitting coils to reliably activate the implanted LED lights, the animals had to be within a certain distance from the coil, which limits movement. The team is now looking into replacing electromagnetic induction with biocompatible batteries to power the lights, and also avoiding exposure to electromagnetic radiation.

As with all cell therapies, the system will have to work in patient-derived cells or other cell types that wont generate an immune response after implantation.

With the FDA approving the first closed-circuit automatic insulin pump last year, Yes optogentics-meets-cell-therapy system may not ever hit the market. But thats not the point.

How soon should we expect to see people on the street wearing fashionable LED wristbands that irradiate implanted cells engineered to produce genetically encoded drugs under the control of a smartphone? asks Gomesky rhetorically.

Not just yet, he answers, but this study offers an exciting glimpse into the promising future of smart-cell therapies and what may soon be possible.

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A.J. Foyt on fear, his stem cell therapy and more – IndyStar – Indianapolis Star

Posted: May 11, 2017 at 12:41 pm

The Indy 500 legend has been through several highs and lows recently. Clark Wade/IndyStar

Indianapolis 500 legend A.J. Foyt.(Photo: Clark Wade/IndyStar)Buy Photo

Its been a long and wild ride, and A.J. Foyt has enjoyed nearly every second of it.

I had a lot of fun, the 82-year-old racing legend told IndyStar on Wednesday at his racing garage in Speedway. If I passed out talking to you right now and fell on the floor, at least I made good money, had a happy life and what else can you ask for? So many people are so miserable with their jobs and that. I had a wonderful job doing what was fun.

Foyts job driving into racing's history books provided him with a lifetimes worth of close friends, amazing stories and thrilling adventures. But it also often required him to put his life on the line.

"I guess I was a little bit crazy back in those days,"Foyt, who walks with a limp but without assistance, said with a smile.

But being crazy was part of the job, he said. He needed it to overcome his fears.

"A lot of race drivers you talk to these days say they've never been scared in racing," Foyt said. "Well, they're lying to you and they're lying to themselves. I cannot name you one race at one time or another thatI didn'tscare the hellout of myself. Honestly. I don't know if that's good or bad, but I'm just being honest with you."

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Despite thosehealthy fears, his long and prestigious racing career resulted ina laundry list of injuries and eventual ailments that would and have horrifieddoctors.

The four-time Indianapolis 500 champion has stared death and dismemberment in the face more times than hed care to count, dealing withcar wrecks, killer bees, a bulldozer accident, heart ailments and two staph infections. As a result, hes nearly had his feet amputated,broken his back two or three times, has two false knees and a false hip, a titanium plate in his chest from open heart surgeryand said hell be on antibiotics for the rest of his life because of the amount of metal he has inside of him.

But he's far from discouraged and fightsto keep going with the same vigor and courage the colored his youth. One way he's done so recently is by undergoing stem cell therapy.Foyt said his wife, Lucy, who suffers from diabetes and arthritis, suggested that they both take on the treatment in order to try and find "the fountain of youth."

I mainly did it for her, Foyt said. She got sugar diabetes real bad, and (is) pretty sick, but, of course, I did it for myself too, dont get me wrong. But shes really been suffering the last five or six years. So we just thought wed try it.

A.J. and Lucy Foyt spent seven days in Cancun, Mexico the treatment is not performed in the United States undergoing a therapy he said likely wont take effect for another month at least. A.J. Foyt had adult stem cells injected into each shoulder and ankle, as well as into his blood.

Theres no guarantees the treatment will help either of them, but the uncertainty doesnt bother him.

I figure if we gain something, fine, and if we dont, well, Ive lost before," Foyt said.

But giving Foyt an edge in his fight against injury, ailment and Father Timeis a competitive fire that has burned within him his whole life.

A little more than a month ago, Foyt and fellow driving legend Dan Gurney were honored in Long Beach, Calif., for the 50th anniversary of their all-American victory at 24 Hours of Le Mans. Many racing greats attended the event, and Foyt was happy to see them, but he couldn't help but stackhimself up one more time against his old rivals.

I guess Im doing better than them, Foyt said with a smile. Poor Parnelli (Jones) has a lot of back trouble. Dan was in a wheelchair. Last three or four years Ive been going in and out of them, but Im still going pretty strong. So far Im hanging in there pretty good. ...Every days a good day. And Iguess thats good when youre getting ready to kick."

Follow IndyStar Motor Sports Insider Jim Ayello on Twitter and Instagram: @jimayello.

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Tocagen Presents Data at the American Society of Gene and Cell Therapy 20th Annual Meeting – PR Newswire (press release)

Posted: May 11, 2017 at 12:41 pm

Title: Long-term follow-up data from 126 patients with recurrent high grade glioma from three Phase 1 trials of Toca 511 and Toca FC: Update and justification for a Phase 2/3 trial Presentation Type: Podium Session: Immunotherapy Clinical Trials for Cancer Presenter: Douglas Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen Summary: As previously presented, data from three Phase 1 trials of Toca 511 and Toca FC in 126 patients with recurrent high grade glioma demonstrate potential benefits, including durable objective responses, extended overall survival and a favorable safety profile.

Title: TOCA 511 & 5-FC: Anti-tumor activity, immune memory and prolonged survival even at low infection levels Presentation Type: Poster Session: Cancer-Immunotherapy, Cancer Vaccines I Presenter: Kader Yagiz, Ph.D., research scientist at Tocagen Summary: Data from preclinical models suggest that even a small percentage of Toca 511 infection results in anti-tumor immune activation and a significant increase in survival following 5-FC treatment.

About Tocagen

Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen is developing its lead investigational product candidate, Toca 511 & Toca FC, initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Toca 511 & Toca FC was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent HGG. Tocagen has received grant support from leading brain cancer foundations, includingAccelerate Brain Cancer Cure(ABC2),National Brain Tumor Society(NBTS), American Brain Tumor Association (ABTA),Musella FoundationandVoices Against Brain Cancer (VABC).

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/tocagen-presents-data-at-the-american-society-of-gene-and-cell-therapy-20th-annual-meeting-300455756.html

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http://tocagen.com/

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Cell Transplant Offers Hope For Type 1 Diabetes – WebMD

Posted: May 11, 2017 at 12:40 pm

By Serena Gordon

HealthDay Reporter

WEDNESDAY, May 10, 2017 (HealthDay News) -- Scientists report a step forward in the plan to create a truly artificial pancreas, offering new hope to people with type 1 diabetes.

A 43-year-old single mother with dangerously difficult-to-control diabetes had insulin-producing islet cells transplanted into her omentum -- a fatty membrane in the belly.

The cells began producing insulin faster than expected, and after one year she is doing well and doesn't need insulin injections, the University of Miami researchers said.

"We're exploring a way to optimize islet cell therapy to a larger population. This study gives us hope for a different transplant approach," said the study's lead author, Dr. David Baidal. He's an assistant professor in the university's Diabetes Research Institute.

Others voiced optimism as well. "This study was a good start at evaluating a novel site for transplant," said Julia Greenstein, vice president of discovery research for JDRF (formerly the Juvenile Diabetes Research Foundation).

Type 1 diabetes is an autoimmune disease. That means the body's immune system mistakenly damages healthy cells -- in this case, the islet cells found in the pancreas. This leaves people with type 1 diabetes without enough insulin to convert sugars from foods into energy for the body.

As a result, they must take multiple daily insulin injections, or use a pump that delivers insulin via a tube inserted under the skin that must be changed every few days.

Currently, islet cells from deceased donors are transplanted into the liver, but that's not an ideal option.

This new research was a proof-of-concept study expected to be the first step on a path toward developing a mini-organ called the BioHub.

In its final stages, the BioHub would mimic a pancreas and act as a home for transplanted islet cells, providing them with oxygen until they could establish their own blood supply.

The hope is that the BioHub also would attempt to tackle the autoimmune attack that causes type 1 diabetes.

But, the first step in developing the BioHub was to find a suitable location in the body. When the liver is used for islet cell transplants, only a limited amount of islet cells can be transplanted. There's also a risk of bleeding when the transplant is done and the possibility of other complications, the researchers said.

"For most people, the liver isn't a problem. It's a great source of blood. It's a good place for insulin to be made. But, there are rare complications that can occur and we want to be able to explant [take the cells out] in case something does happen," said Greenstein, adding that you can't take the cells out of the liver.

Also, with islet cell transplants in the liver, the underlying autoimmune condition is still there. And, if people didn't take immune-suppressing medication, the new islet cells would likely be destroyed.

Because of these and other issues, islet cell transplantation is generally reserved for people whose diabetes is very difficult to control or who no longer have an awareness of potentially dangerous low blood-sugar levels (hypoglycemia unawareness).

The woman in the current study had a 25-year history of type 1 diabetes. She also had severe hypoglycemia unawareness.

"Her quality of life was severely impacted. She had to move in with her parents. And, if she traveled, she had to travel with her father" in case her blood sugar levels dropped dangerously low, Baidal explained.

The surgery was minimally invasive, and the islet cells were placed on a "scaffold" that eventually dissolved. There were no complications, the researchers said.

"We were happily surprised when her glucose [blood sugar] profile improved quite dramatically," Baidal said.

Normally, after a transplant, doctors wait a while before stopping insulin to give the new islet cells a chance to rest. But the new islet cells worked so well that the injected insulin was causing low blood sugar levels.

"We were able to discontinue insulin sooner than we thought we would. And, the glucose control was very stable," Baidal said.

Baidal said the study results need to be replicated in other patients, and the researchers want to see what happens post-treatment over a longer time. The researchers plan to test the omentum as a site in five more patients.

Greenstein said a big clinical trial isn't necessary because "either the transplant works or it doesn't work," so only a small number of people is needed.

The study's findings were published online May 10 in the New England Journal of Medicine.

WebMD News from HealthDay

SOURCES: David Baidal, M.D., assistant professor, division of endocrinology, diabetes and metabolism, and clinical cell transplant program, Diabetes Research Institute, University of Miami Miller School of Medicine; Julia Greenstein, Ph.D., vice president, discovery research, JDRF; May 10, 2017, New England Journal of Medicine

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Poxel Takes High-Energy Approach To Diabetes – Seeking Alpha

Posted: May 11, 2017 at 12:40 pm

In the highly competitive space of diabetes, players will look for any edge they can get. One way companies can set themselves apart is by targeting a new mechanism of action - and this is the approach that the French group Poxel (OTC:PXXLF) has taken with imeglimin, a mitochondrial bioenergetics enhancer.

Mitochondrial dysfunction has been linked with diabetes for some time, but Poxel is alone in this niche, its chief executive Thomas Kuhn believes. "We don't think there are any other products in the clinic targeting mitochondria for the treatment of type 2 diabetes," he tells EP Vantage.

This could make Poxel attractive to the bigger fish in the diabetes sector, which have been contending with US pricing pressure and slowing sales growth. And positive data from a Japanese phase IIb study of imeglimin reported last week cannot have hurt its cause ("Novo needs new blood despite earnings relief," May 4, 2017).

More energy

By targeting mitochondria, Poxel hopes to address an underlying issue in type 2 diabetes. Patients have dysfunctional mitochondria because "they usually eat too much, until they have an excess of nutrients coming into the mitochondria. On the other hand, they don't exercise as much as they should," Mr. Kuhn says.

Overall, this leads to an excess of nutrients and a low demand on energy, which creates oxidative stress that impairs mitochondrial function, according to the chief executive.

"Imeglimin restores normal functioning by increasing the capacity of the different proteins of the mitochondria to transform nutrients into energy - even in the diabetic pathological process."

Mr. Kuhn is adamant that Poxel will press on alone in Japan, where it should only need a relatively small phase III program - three trials of roughly 1,000 patients each, he estimates - to get approval. "The path to market is reasonable compared with other countries," he says. "This is something we have the experience for - we have a team in Japan that's looking after the clinical and regulatory processes."

The company plans to start phase III in the fourth quarter and hopes to submit imeglimin for Japan approval by the end of 2018. It will need more cash for this - Poxel only had 38.8 million ($42.2 million) in the bank as of the end of March 2017.

This lack of funds helps explain why development in the US and Europe has stalled in spite of promising data from a phase IIb dose-ranging trial in December 2014, which supported taking a 1,500mg dose of imeglimin monotherapy into phase III.

Mr. Kuhn admits that Poxel will need a partner to support a pivotal program here, which he believes will need to total seven trials in around 7,000 patients overall. He says the company is already in talks with potential collaborators, in parallel with discussions with the FDA and EMA about study design.

With the onerous requirement of huge trials to tease out cardiovascular risk in Europe or the US, it will take a bold partner to jump in on such a novel diabetes approach.

AMP it up

Meanwhile, Poxel has an earlier-stage diabetes asset with another novel mechanism, the direct AMP kinase activator PXL770.

According to EvaluatePharma, no AMPK activators are approved in diabetes, though Betagenon's O304 is already in phase II, putting it ahead of PXL770. There are also various projects in preclinical development.

Like imeglimin, PXL770 is designed to regulate energy - the AMPK enzyme's role is to maintain cellular energy homeostasis. "Put simply, our product will mimic the benefit of doing sport - that's the concept," says Mr. Kuhn.

However, Poxel has had a hiccup in development. It had to go back to the preclinical stage after a phase I trial found differences in the way the product was metabolised in humans versus animals. The chief executive insists that no safety worries were uncovered in the clinic, and the company hopes to start the second phase of the phase I trial in the second half of this year.

PXL770 acts directly on the liver, Mr. Kuhn says, so could also have utility in diseases such as Nash. The Nash space has garnered a lot of attention - and investment - potentially providing another avenue for Poxel to attract a partner.

But with limited resources, Poxel will not want to stretch itself too thinly. For now, the focus has to be on progressing imeglimin in diabetes.

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Growth in Stem Cell Research – Financial Tribune

Posted: May 9, 2017 at 11:42 pm

Iran is expanding investment in stem cell research and its application in various therapies, particularly for hard-to-treat diseases, through the Office of the Vice- Presidency for Science and Technology. As a result of the increase in the number of companies active in the domain of stem cells in the past three years, more than 400 products are processed in the country, indicating a multifold growth compared with the eight-year tenure of previous administration when there were fewer than 50 knowledge-based firms in total.

There are over 40 knowledgebased firms in the field of stem cell and regenerative medicine alone in Iran today, said Amir Ali Hamidiyeh, secretary of the Headquarters for Development of Stem Cell Science and Technology (HDSCST). He made the statement at a press briefing for the second National Festival and International Congress on Stem Cell Sciences and Technologies and Regenerative Medicine to be held July 13- 15 in Tehran, Mehr News Agency reports. According to the conference secretariat, 1,444 people have signed up to attend the event from across the world, including from Iraq, India, Pakistan, Jordan, Russia, Australia, Germany, China, Britain and South Korea. They all are among their countrys respected figures in centers with high academic standing.

The congress is co-sponsored by the Vice-Presidency for Science and Technology and Council on Development of Stem Cell Sciences and Technology. So far, eight stem-cell therapy products for use in hospitals have been produced at the HDSCST laboratories. Manufacturinglicenses have been granted for anadditional number, while others are on thewait list.

Prior to 2014, only 25 knowledgebased companies had applied to operate in this field, of which only one was actively producing quality stem cell products, Hamidiyeh pointed out.

But since then, over 25 workgroups have been formed in cooperation with experts in the specific sciences. Stem cells are cells that have the ability to divide and develop into many different cell types in the body during early life and growth. Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

Future of Medicine in Stem

Cells The future of medicine is interrelated with stem cell therapy and the treatment ofrefractory and incurable diseases is in this field of medicine, according to Dr. Ahmad Vosouq Dizaj, the clinical deputy of Royan Institute. Having access to engineering sciences as well as the combination of biology and medicine can play a crucial role in redressing health problems, he said. Stem cells have the ability to replace damaged cells and treat disease. They can also be used to study diseases and provide a resource for testing new medical treatments. The use of stem cells reduces the risk of viral diseases transmission and incidence of Graft Versus Host Disease (GVHD). The ability to perform organ transplants is among the benefits ofumbilical cord blood transfusion.Using stems cells is also one of thebest ways to treat blood diseases sincethe method has a success rate of 70%worldwide.

Storage of stem cells is a valuable investment. So far, 27 cord blood banks have been launched across the country. There are two types: public and private banks for stem cell storage. The former does not charge a fee for storage. But in the latter, the cost of collection and genetictesting is about $645 and the annualcharge for storage is $33, according toISNA.Iran is a leading country in biomedicalresearch. Researchers and physicians have been successfully performing bone marrow transplants during the past fewyears.Irans stem cell research is centeredat the Royan Institute for ReproductiveBiomedicine, Stem Cell Biology andTechnology, located in northern Tehran.

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US Stem Cell Inc (OTCMKTS:USRM) Starting to Open Eyes – The Oracle Dispatch

Posted: May 9, 2017 at 11:42 pm

White Papers are used often by Biotech companies as a tool to secure financing and US Stem Cell Inc (OTCMKTS:USRM)utilized a White Paper Series to open the eyes of investors as to how significant the results were. Normally this prompts those who take the time to read them and creates an Ah Ha, moment where the light goes on for the investor.

If you look at the timing of the White Paper released by Kristen Comella in late January you can see how the market reacted to this information. The stock went from triple zero sub penny to near .13 cents, which is a very large move. USRM went on to secure financing and has funding for operations for years to come, it is good to see stocks where this process works with fluidity, more microcap stocks should be looking at employing this White Paper marketing strategy to secure investors.

US Stem Cell Inc (OTCMKTS:USRM)is a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies to human and animal patients.Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease was published in the January volume of theJournal of Translational Medicine. The study focused on the implantation of stromal vascular fraction (SVF) in patients suffering from degenerative disc disease. Patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue from the abdomen. The fat was separated to isolate the SVF and the cells were delivered directly into the damaged discs. Patients were monitored for a period of 6 months post-treatment, noting considerable decreases in pain and increases in flexion.

Ms. Comellas previous paper, Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy, was released in theJournal of Translational Medicines June 2016 edition. Using the same procedure, chronic ischemic cardiomyopathy patients were evaluated after SVF injection and able to walk more than 80 additional meters 3 to 6 months after treatment.

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U.S. Stem Cell, Inc., is committed to new technological advancements and therapies that give a renewed sense of hope to patients with degenerative diseases. SVF is the latest therapy in a long line of successful treatments the company pioneered. Ms. Comella plans to continue her work with SVF, which has consistently repeated its strong safety profile and success in treating patients.

The second piece of the puzzle was raising capital and the company recently secured a commitment to invest up to $5,000,000 from private equity firm General American Capital Partners LLC (GACP) in exchange for up to 63,873,275 shares of common stock.

We see exponential growth in the stem cell industry, estimated to grow to $170 billion by 2020, said Joseph DaGrosa, Jr., a Principal with General American Capital Partners. We are very pleased to join forces with U.S. Stem Cell, Inc., a leader in regenerative medicine solutions, to help expand our role in this important market.

The 21st Century Cures Act, signed into effect in December of 2016, builds on the FDAs ongoing efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, with continued assurance from high quality evidence that they are safe and effective.

Patient demand for regenerative medicine procedures as a viable alternative to surgery, as well as the transformative capacity of stem cell therapies, are leading the way to increased acceptance by both the medical and regulatory communities, said Mike Tomas, President and CEO of U.S. Stem Cell, Inc.

Few know that as recently as December 2015 these shares were near $2.00 as stem cell was a sector in biotech that had big multiples and a larger hope for the future. U.S. Stem Cell, Inc. (OTCMKTS:USRM) has renewed this hope for many shareholders who have stayed with the stock. Through consolidation and internal organizational changes the company has combined operating divisions (US Stem Cell Training, Vetbiologics, and US Stem Cell Clinic)which include the development of proprietary cell therapy products. They also generate physician and patient based regenerative medicine and cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic.

The White Papers take the time to explain how the science works, and all this company needed was one yes answer from a larger investor to secure financing to jump start operations and ultimately the stock price. USRM is one of the most exciting stories on the OTC stay tuned we will update the story soon.For more news on $USRM and other fast-moving penny stocks, please subscribe to OracleDispatch.com below.

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