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Budget Subcommittee Chair Portantino Submits Funding Plan – Pasadena Now

Posted: May 24, 2017 at 7:47 pm

State Senator Anthony J. Portantino closed out the Senate Budget Subcommittee on Education last week with several important additions and ratifications to Gov. Jerry Browns recently released revised budget.

Among the highlights that Portantinos subcommittee added are a proposal to increase Cal Grants for community college students, to include additional funding for transportation and other costs associated with attending college; funding childcare; funding for After-School Education and Safety (ASES); increasing accountability and transparency at the University of California; and including funding for the Summer Institute for Emerging Managers and Leaders (SIEML) initiated by Portantino when he was in the State Assembly.

The SIEML institute is a summer program for undergraduate students from historically black colleges and Hispanic-serving institutes at the seven University of California Business Schools. The funding is intended to fund the school-based institute and bring accountability to the UC Office of the President to administer the program.

The subcommittee also accepted Gov. Browns proposal to create a continuous appropriation to the University of California Davis Cord Blood Collection Program. This is another successful program initiated by Portantino that is providing life-saving cord blood stem cells to Californias diverse population.

The subcommittee also included $16 million to implement an updated History-Social Science curriculum framework with guidelines for public school teachers, something that is of particular to the 25th Senate District as the study of the Armenian Genocide is one of the subject areas.

Another major step the subcommittee took is that is restored Cal Grants for nonprofit colleges. Gov. Brown had originally proposed to only partially fund Cal Grants for Latino students, then added some restrictions that would make it difficult for students at these schools. The Subcommittee approved full funding of the Cal Grants but rejected the strings attached to them.

The subcommittee also accepted the increase in the Local Control Funding Formula (LCFF); implementation of the LCFF helps many of the school districts across the 25th Senate District and the San Gabriel Valley.

After proposing that Gov. Brown not defer nearly a billion dollars in Proposition 98 funding in the January budget, the subcommittee accepted the governors May revised plan to fully fund this money to K12 districts. It also deferred action to the full Senate Budget Committee Gov. Browns plan to add an additional billion dollars to K12 but make this money available only in 2019.

It is our subcommittees job to review the Governors plan for education in California and reject, approve or improve on his proposals, Portantino said. I was very pleased with the committees work and proud of my colleagues for preparing this plan for our students and families. From here our plan goes to the full Senate Budget Committee for deliberation and completion.

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Scientists wary as Texas mulls allowing sale of unproven drugs – Bryan-College Station Eagle

Posted: May 24, 2017 at 7:46 pm

A group of scientists and medical professionals is sounding the alarm in the final days of the Texas legislative session about a little-noticed bill that would allow manufacturers of unproven drugs to sell their products to dying patients.

Supporters ofHouse Bill 3236by state Rep.Kyle Kacal, R-College Station, say it could help incentivize drugmakers to get promising, experimental drugs onto the market and into needy patients hands. Its detractors say it would allow drug companies and quack doctors to use fake medicine to take advantage of sick, vulnerable families.

After emotional pleas from state lawmakers invoking family members with terminal illness, the Texas House passed the measure earlier this month in a unanimous 142-0 vote, just minutes before a critical deadline. The bill is now waiting to be heard by the Senate State Affairs Committee.

From the House floor, Kacal whose mother died of ovarian cancer said he hoped it would help make experimental drugs "accessible to everybody."

Asked by state Rep.Jonathan Stickland, R-Bedford, about concerns that the proposal could have unintended consequences, Kacal said he had "vetted the bill very well."

But that has not eased the fear of some patient advocates.

Its the dirtiest, most corrupt, most transparently fraudulent bill Ive ever seen in my life, said Will Decker, a Houstonimmunologist who sits on the medical board for the advocacy group Texans for Cures. It exists for one purpose and one purpose only: to let patients pay for snake oil.

The debate this year is a new development in Texas right to try movement, which advocatesthat terminally ill patients should be allowed to try long-shot therapies that havent received final approval by the U.S. Food and Drug Administration a process that can be lengthy.

The movement, backed by the libertarian Goldwater Institute, is gaining traction in state legislatures around the country; 35 other states havepassed similar laws. Of those, Texas is the only statethat prohibits patients from paying for experimental drugs, said Starlee Coleman, a policy adviser for the Arizona-based institute.

In an interview, Kacalsaid his bill was meant to reduce barriers for sick patients to access potentially life-saving drugs. While most drugs provided through compassionate use are donated to patients, free of charge, by large pharmaceutical companies, Kacal said smaller drug-makers need to be able to recoup some costs by charging patients.

If [smaller drug companies] say yes, but I need a small, nominal fee, I dont think the patient or the doctor is going to argue, he said. Were going to find a way to get that product to the individual.

The FDA already has a compassionate use program to helpterminally ill peopleaccess unapproved drugs. But few patients take advantage of the program; in 2015, about 1,900 patients applied for drugs through the program,according to STAT News.

Texas right to try law, passed in 2015, applies to drugs that have passed the FDAs phase 1 clinical trial, which essentially verifies that the drug will not harm a patient but doesn'tprove a drugs effectiveness.

The 2015 law requirespharmaceutical companies to provide experimental drugs without compensation, butKacals bill would allowdrugmakers tocharge patients for the costs of, or the costs associated with, the manufacture of the investigational drug.

Federal regulations prohibit companies fromprofiting fromexperimental medicine. Michelle Wittenburg,a lobbyist and president of theKK125 Ovarian Cancer Research Foundationwho supports Kacals bill,said thereare simply not enough patients receiving drugs through the federal compassionate use program to tempt bad actors who might want to take advantage of desperate people.

Youd have to have a lot of people seeking and getting it for anyone even someone trying to be a bad actor to actually make money off of it, she said.

The measure is backed by industry players including CellTex Therapeutics, a stem cell research company known in Texas political circles because former Gov.Rick Perryused to serve on its board (the company was involved in a back surgery Perry underwent in 2011 in which he received anexperimental injection of his own stem cells, a therapy that isnt FDA approved). In 2013, after a warning from the FDA, the companymoved its treatment operations to Mexico.

Sally Temple, the president of the International Society for Stem Cell Research, wrote Texas lawmakers this month to oppose the bill, saying it would allow companies to sell unsafe and ineffective therapies.

It may sound like an appealing idea to allow seriously ill patients accelerated access to experimental therapies, she wrote. However, in the absence of full clinical testing, these bills will allow snake oil salesmen to sell unproven and scientifically dubious therapies to desperate patients.

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Puma Biotechnology FDA Live Blog – Forbes

Posted: May 24, 2017 at 7:44 pm


Forbes
Puma Biotechnology FDA Live Blog
Forbes
This is a live blog of the meeting of the Food and Drug Administration's meeting regarding neratinib, a breast cancer drug being developed by Puma Biotechnology. The basic questions to be addressed, per my story from Monday. Puma's not applying to sell ...
Why Puma Biotechnology Inc Jumped Higher TodayMotley Fool
Puma Biotechnology Receives FDA Advisory Committee Support for NeratinibBusiness Wire (press release)
Puma Biotechnology (PBYI) PT Raised to $86 at BofA/Merrill LynchStreetInsider.com
ExpertGazette -Equities.com -Finance News Daily -Zacks
all 71 news articles »

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Amicus Therapeutics: A Rare Find In Biotechnology – Seeking Alpha

Posted: May 24, 2017 at 7:44 pm

Amicus Therapeutics (NASDAQ:FOLD) is a global biotherapeutics company focused on rare genetic devastating diseases. The company has advanced its precision medicine, Galafold (migalastat), in treating patients in Europe with Fabry disease (alpha galactosidase A deficiency), a rare X-linked genetic lysosomal disorder in which sphingolipids are not metabolized properly. Galafold, an orally administered drug, is the first medicine approved (EMA but not yet FDA) for treatment of Fabry disease. Other goals for 2017 include submitting a J-NDA (Japan) for migalastat, establishing a clinical plan for ATB200/AT2221 in Pompe disease, completion of phase 3 clinical trial in epidermolysis bullosa.

FOLD announced its regulatory plan with FDA for U.S. treatment with Galafold in advancing it's Fabry disease program including two phase 3 trials in late 2016. As previously mentioned, the EMA approved use of Galafold for treatment of Fabry disease. The company published data from its pivotal trial in the New England Journal of Medicine. A statistically significant benefit was conferred by Galafold in 50 patients with treatable mutant galactosidase alleles. However, a closer look at the trial endpoints reveals that the study failed to reach its primary endpoints including greater than 50% reduction in GL-3 inclusions per kidney, and if all 67 patients were included in the study (including mutant alleles that are not expected to benefit by Galafold). More studies are needed for FDA going forward. It could be well worth the company's investment, as the market for Fabry's disease is estimated to be in excess of $1.2 billion by 2024.

December 2016, FOLD announced positive early phase 1/2 data for Pompe disease, a rare genetic disorder leading to the buildup of glycogen in the body, particularly the muscles, which become impaired in function. The study showed a positive safety profile with no serious adverse events and generally showed musculatoprotection as shown by biomarkers of muscle damage. The study is divided into three cohorts: non-ambulatory ERT-switch, ERT-switch, and ERT-naive. Creatine kinase, alanine aminotransferase, and aspartate aminotransferase levels showed a trend towards improvement in half the patients and were stable in all. ATB200/AT2221 has a unique mechanism of treatment that uses ATB200, a recombinant functional alpha-glucosidase enzyme carrying mannose-6 phosphate moieties designed to increase uptake. AT2221 is a pharmacological chaperone co-treated to stabilize the compound. The company believes that its Pompe program (with market of $1.2 billion) will be a driver in its growth with 12% CAGR as a world's leading rare disease company. Key study readout dates include Q2 and Q3 2017.

SD-101 is currently in phase 3 studies as a topical for Epidermolysis Bullosa, and FOLD believes it will be the first-to-market therapy for the rare indication. The inherited disease is characterized by blistering of keratinized outer skin, wet skin (such as mouth), and internal organs. Serious complications include infection, pain, and even death. The company was granted FDA Breakthrough Therapy Designation in 2013 based on results from its phase 2a study, having demonstrated wound closure in all disease types. Strong Bio has previously written about the impacts of FDA Breakthrough Therapy Designation on biotechnology stocks, and if you are an investor and have not perused the article, now might be a good time, as it is a part of the investment plan for FOLD. Phase 3 top-line data for the 160 patient study in which 95% of the patients elected to continue the open-label extension is due Q3 2017. This statement could be the company's way of saying they find it likely it will have clinical benefit for patients. Since it has been observed that FDA breakthrough therapy status stocks get volatile late in stage 3, any sharp drops may indicate stock manipulation that interested investors might jump on with a small position. Strong Bio regards FOLD as a nice investment prospect for any unexplainable late Q2 early Q3 pullbacks. With significant market potential of $1 billion, severe symptoms, and 30,000 sufferers in the U.S. alone, its worth watching for that pullback. One competitor, RegeneRx (OTCQB:RGRX) has initiated phase 3 trials for RGX-137 (active ingredient thymosin beta 4 wound healing gel) in the condition as well.

Cash burn was $55 million in first quarter 2017. Cash on hand at end Q1 was $280 million. The current runway is expected to last through the second half of 2018. Seven analysts average about $12 per share for FOLD, which is currently trading at about $8, which may be a slight pullback from fair value. Strong Bio will look for dips in price below $6 for no a brainer initial position. If all three drugs get FDA approval, this stock could be off to the races. Strong Bio has learned a lesson from Amicus. Rare diseases may have surprisingly large markets!

Risk factors for FOLD could include dilution (which may be yet another entry opportunity). Risks also include FDA approval and/or regulatory delays for all three major indications. Clinical trial design will be key, because FDA wants a clear metric upon which to agree with FOLD to approve these rare disease therapies. Large scale GMP-compliant manufacturing for U.S. application will also be a significant but manageable obstacle. Because the company has a market cap over $1.1 billion dollars, SD-101 key readout will be very important in terms of valuation for FOLD stock. If approved by FDA, the stock could easily triple in value over the next year. With ATB200/AT2221 being regarded as a key driver in value by the company, 2017 is going to be a pivotal year for FOLD. With three candidates all on the verge of pivotal data, this is a must-watch!

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Why Abercrombie & Fitch, Triumph Group, and Puma Biotechnology Jumped Today – Motley Fool

Posted: May 24, 2017 at 7:44 pm

Wednesday was a good day for stocks, and the Dow Jones Industrials and S&P 500 both climbed through milestone levels. Most market participants attributed the positive sentiment to the Federal Reserve, which released the minutes of its latest monetary policy meeting during the afternoon. The central bank revealed plans to clamp down on the size of its balance sheet, which it initially expanded in the aftermath of the financial crisis to provide liquidity to the bond market and additional stimulus to the U.S. economy. Investors were pleased that the Fed believes that it's no longer necessary to extend that level of monetary accommodation to the economy. In addition, some individual companies had extremely good news, and Abercrombie & Fitch (NYSE:ANF), Triumph Group (NYSE:TGI), and Puma Biotechnology (NASDAQ:PBYI) were among the best performers on the day. Below, we'll look more closely at these stocks to tell you why they did so well.

Shares of Abercrombie & Fitch climbed 6% in the wake of reports that the teen retailer might receive an acquisition bid from a consortium of investors. According to The Wall Street Journal(subscription required), industry peer American Eagle Outfitters (NYSE:AEO) and private equity company Cerberus Capital Management are looking at putting together a potential buyout offer for Abercrombie & Fitch, following speculation that other players in the industry might also be interested in consolidation. A&F has been dealing with takeover speculation for a while, and it has typically noted that any discussions wouldn't necessary translate into actual offers. Yet with Abercrombie set to release its first-quarter financial results Thursday, investors will want to see signs that the company can take care of its challenges on its own -- or else they'll start clamoring more loudly for a buyout to take place.

Image source: Getty Images.

Triumph Group stock soared over 30% after the company announced its fiscal fourth-quarter financial results and resolved a dispute with aircraft manufacturer Bombardier. The aerospace components and systems specialist said that sales fell 13% from year-ago levels, and it posted a GAAP loss of $126.8 million. With challenges in its aerospace structures business, Triumph has focused on amending contracts and addressing operational and financial challenges, and the company's transformation plan has led to improving free cash flow and cost savings. Investors were also happy that Triumph reached a settlement of all of its disputes with Bombardier. Triumph said that the agreement "resets the commercial relationship between [Triumph] and Bombardier and allows each of them to better achieve their business objectives going forward."

Finally, shares of Puma Biotechnology jumped 30%. The biopharmaceutical company earned a hoped-for approval from the U.S. Food and Drug Administration advisory panel looking at its neratinib candidate treatment for breast cancer. The panel voted 12 to 4 in favor of recommending the drug to the FDA, and although panelists expressed some thoughts about potentially limiting the size of the group of women eligible to use the drug, investors nevertheless took the news as a positive. The FDA still needs to make its own decision about Puma's drug, and it isn't bound by the opinion of the advisory panel. Nevertheless, today's recommendation moves Puma one step further to getting a big win under its belt, and shareholders recognized that fact with the second big move in the stock this week.

Dan Caplinger has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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BBP: A Diversified Biotech ETF – Seeking Alpha

Posted: May 24, 2017 at 7:44 pm

While 2017 has been a pretty good year overall for biotechs - the two largest ETFs in the space, the iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) and the SPDR S&P Biotech ETF (NYSEARCA:XBI), are up 10% and 17%, respectively - it's tough to forget that both of these funds are still about 25% off of their 2015 highs. IBB, which is heavily influenced by the largest biotech names, has been impacted by 50% drops in Gilead (NASDAQ:GILD) and Biogen (NASDAQ:BIIB). XBI has a much more diversified all-cap mix but has experienced similar results.

But not all news coming out of the sector is bad. In fact, one biotech ETF has been downright ripping it since its launch at the end of 2014. The BioShares Biotechnology Products ETF (NASDAQ:BBP), which invests in companies that have at least one primary product that's received FDA approval, is up roughly 42% since its inception at the end of 2014 compared to a loss of 4% for IBB during the same time frame.

IBB Total Return Price data by YCharts

As fund advisor Virtus says on its website, companies that the fund invests in are "typically more established companies with much clinical trial failure risk behind them. They have already successfully completed multiple human clinical trials and have received FDA approval to sell and market a drug." That sounds a lot like IBB so what's the big differentiator between the two funds? It's BBP's focus on small- and micro-cap biotechs. Nearly 60% of fund assets are dedicated to this space whereas IBB has nearly 40% of the portfolio alone invested in the big five of Regeneron (NASDAQ:REGN), Biogen , Celgene (NASDAQ:CELG), Amgen (NASDAQ:AMGN) and Gilead .

So what did BBP have going for it that IBB didn't over the past year or so? I think it's a combination of portfolio construction and M&A.

BBP has a portfolio that has performed almost as well as can be expected, especially in 2017. Take a look at this chart with the year-to-date performance of the fund's biggest components.

That's exactly what you want to see out of your ETFs - the largest holdings performing the best. Part of that is due to the fact that the fund is equal-weighted and rebalanced semiannually (the last rebalance was done on December 15th). Still, that's a lot of companies whose stocks have risen by 20% or more.

Among the top 10 holdings, all have posted double-digit gains with seven components delivering 25%+ gains.

The other advantage the fund has is that a number of its holdings are in the sweet spot of being developed enough to generate meaningful revenue from their approved product line yet being small enough that they can be potential takeover targets. We've seen that within the fund multiple times recently. Relypsa (RYLP) has a top holding when it got bought out by Galenica (OTC:GNHAY). Not an M&A deal, but the fund's stake in Progenics (NASDAQ:PGNX) spiked when its partnership with Valeant (NYSE:VRX) was announced. Current holdings such as Exelixis (NASDAQ:EXEL) and Acadia (NASDAQ:ACAD) have been rumored as potential takeover targets for a while so further action could be in store for the fund in the near future as well.

Conclusion

Equal weighting the mature biotech players has been a strategy that's paid off for investors in the last year. The relatively limited exposure to the likes of Celgene and Gilead, which are still nearly 50% off of recent highs, has made the fund more attractive than its more well-known counterpart.

This fund will underperform when the mega-cap biotech names begin to rally again, but over the long-term this ETF should hold up well to IBB given its more diversified portfolio.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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The Technical Chart For Puma Biotechnology, Inc. (PBYI) Is Very Revealing Today – NY Stock News

Posted: May 24, 2017 at 7:44 pm

The Technical Chart For Puma Biotechnology, Inc. (PBYI) Is Very Revealing Today
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The technicals for Puma Biotechnology, Inc. (PBYI) has spoken via its technical chart and the message is loud and clear. Based on that message, this is the relevant information necessary to make sense of that current setup. Often the difference between ...

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Researchers identify ‘signal’ crucial to stem cell function in hair follicles – Medical Xpress

Posted: May 24, 2017 at 7:44 pm

May 24, 2017 by Collene Ferguson Jeff Biernaskies research identifies a factor essential for dermal stem cells to continuously divide during tissue regeneration. Credit: Riley Brandt, University of Calgary

Stem cell researchers at the University of Calgary have found another piece of the puzzle behind what may contribute to hair loss and prevent wounds from healing normally.

Jeff Biernaskie's research, published recently in the scientific journal npj Regenerative Medicine identifies a key signalling protein called platelet-derived growth factor (PDGF). This protein is critical for driving self-renewal and proliferation of dermal stem cells that live in hair follicles and enable their unique ability to continuously regenerate and produce new hair.

"This is the first study to identify the signals that influence hair follicle dermal stem cell function in your skin," says Biernaskie, an associate professor in comparative biology and experimental medicine at the University of Calgary'sFaculty of Veterinary Medicine, and Calgary Firefighters Burn Treatment Society Chair in Skin Regeneration and Wound Healing. Biernaskie is also a member of the Alberta Children's Hospital Research Institute.

"What we show is that in the absence of PDGF signalling hair follicle dermal stem cells are rapidly diminished because of their inability to generate new stem cells and produce sufficient numbers of mature dermal cells within the hair follicle."

Biernaskie and his team of researchers study dermal stem cells located within hair follicles. They are looking to better understand dermal stem cell function and find ways to use these cells to develop novel therapies for improved wound healing after injury, burns, disease or aging.

This study, co-authored byRaquel Gonzalez and Garrett Moffatt,shows that PDGF is key to maintaining a well-functioning stem cell population in skin. And in normal skin, if you don't have enough of it the stem cell pools start to shrink, meaning eventually the hair will no longer grow and wounds will not heal as well.

"It's an important start in terms of how we might modulate these cells towards developing future therapies that could regenerate new dermal tissue or maintain hair growth" says Biernaskie.

Biernaskie's lab is looking at the potential role of stem cells in wound healing and the potential to stimulate these cells to improve skin regeneration, as opposed to forming scars.

Explore further: Using stem cells to grow new hair

More information: Raquel Gonzlez et al. Platelet-derived growth factor signaling modulates adult hair follicle dermal stem cell maintenance and self-renewal, npj Regenerative Medicine (2017). DOI: 10.1038/s41536-017-0013-4

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New investigational drug acts like a cancer-seeking missile in brain – Northwestern University NewsCenter

Posted: May 24, 2017 at 7:44 pm

Animation of stem cell therapy attacking malignant glioma. (Northwestern Medicine)

CHICAGO - A first-of-a-kind neural stem cell therapy that works with a common cold virus to seek out and attack a lethal and aggressive brain cancer is being tested at Northwestern Medicine in a Phase I clinical trial for patients newly diagnosed with malignant glioma.

The novel drug to treat malignant glioma, notorious for recurring after typical bouts of standard cancer treatment, was developed by a Northwestern scientist and has been approved as an investigational drug by the U.S. Food and Drug Administration. This is only the second time the University has supported and filed an investigational new drug as a sponsor.

We have discovered that combining stem cells with a virus causes the new drug to react like a cancer-seeking missile targeting cancerous cells in the brain said principal investigator, Dr. Maciej Lesniak, the Michael J. Marchese Professor and chair of neurological surgery atNorthwestern University Feinberg School of Medicineand a neuro-oncologist at Northwestern Medicine. If it works in humans, it could be a powerful weapon against brain cancer and an option that our patients are desperate for.

One reason malignant glioma recurs so often is because a small subpopulation of cancer cells, often deep in the brain tissue, is highly resistant to chemotherapy and radiation.

We havent seen significant progress in the last decade for patients with a brain tumor, and that is why its crucial to do everything we can to find a better treatment for brain tumors.

The pre-clinical work done by Lesniak and his team has shown that the approach being tested at Northwestern Medicine can target this population of therapy resistant cells, further delaying and sometimes even preventing tumor recurrence.

The stem cells used in the research came from a collaboration of researchers from City of Hope.

We havent seen significant progress in the last decade for patients with a brain tumor, and that is why its crucial to do everything we can to find a better treatment for brain tumors, said Dr. Roger Stupp, a co-investigator who is working alongside Lesniak on this clinical trial. Combining novel therapy with medical expertise, we are able to get one step closer to eradicating this lethal disease.

Stupp, a world-renowned neuro-oncologist, recently joined Northwestern Medicine as director of neuro-oncology and associate director for strategic initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. He is best known for developing temozolomide in combination with radiation as the standard-of-care chemotherapy for patients with glioblastoma.

Lesniak and his team of scientists are starting to test the safety and dosage of the treatment in patients at Northwestern Memorial Hospital. Lesniak began the research more than a decade ago while at the University of Chicago and completed it when he moved to Northwestern in 2015.

This investigational new drug contains neural stem cells to deliver a potent virus responsible for the common cold, oncolyotic adenovirus, which is engineered to kill brain cancer cells. The novel treatment works synergistically with chemotherapy and radiation to enhance the standard cancer treatments effectiveness.

Malignant gliomas are the most aggressive forms of cancer and are predicted to affect nearly 20,000 new patients this year, according to the American Brain Tumor Association. Sometimes called the grow-and-go tumors, gliomas can make their own blood supply, which fuels the tumors rapid growth and helps them hatch satellite tumors. Each tumor sends out tentacles that infiltrate and dig deep into normal brain tissue, making complete removal of cancerous cells impossible. Any cancerous cells in the brain left over from standard of care can cause the tumor to recur.

Lesniak plans to enroll up to 36 newly diagnosed patients with glioma. These patients will be divided into two groups: those with tumors that can be removed and those where the tumors are not removable by surgery.

Next step, Northwestern Memorial will extend this research to the collaborating partners at City of Hope Comprehensive Cancer Center in Duarte, California.

The study was funded by the National Institutes of Health and the National Institute of Neurological Disorders and Stroke grant U01NS069997.

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Seed Funding for a German Cell Therapy to Prevent Transplant … – Labiotech.eu (blog)

Posted: May 24, 2017 at 7:44 pm

TolerogenixX has proved that it can get rid of immunosuppressants in organ transplants in Phase I and secured seed funding from High-Tech Grnderfonds.

TolerogenixXis a startup from the Heidelberg University Hospital that developspersonalized immunosuppression therapies. Its cell therapy technology has just passed Phase I, where it showed an impressive efficacy in preventing the rejection of kidney transplants without the need for immunosuppressive drugs.

The promising results seemto have convinced the German life sciences investorHigh-Tech Grnderfonds (HTGF),from which TolerogenixX has secured seed funding. HTGF is the first investor to jump in after pre-seed financing from the German Government. The funds, of an undisclosedamount, will help the startup make the preparations for a Phase II trial, planned for spring 2018.

TolerogenixXstechnology provides individualized immunosuppression, tailored specifically to the donor tissue. To do so,peripheral blood mononuclear cells (PBMCs) are harvested from the donor and treated with mitomycinCand then infused into the patient prior to the transplant.

Researchers at the University of Heidelberg discovered that mitomycin C inducesa change of behavior in dendritic cells, leading them to suppressT-cell responses. Immunological tests conducted during the trial revealed that the recipients had developed tolerance towards the donor.

The TolerogenixX technique represents a milestone in the field of individualized immunosuppression, saidPhilipp Rittershaus, Investment Manager at HTGF. Indeed, the therapy would allow transplantation without the need for immunosuppressants, which carry many severe side effects and leave patients completely unprotected against infections.

If everything goes well,TolerogenixX expects to complete Phase III andfile for approval in 2022. In addition, it will start a second program next year to treat autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus. The methodology would be very similar, just using autologous cells instead for the mitomycin C treatment instead of donor cells.

This is a real quantum leap in the treatment of transplant patients, said in a statement Matthias Schaier, CEO of TolerogenixX. In the future, it will no longer be necessary to take various medications with numerous side effects.

Images via crystal light / Shutterstock;TolerogenixX

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Seed Funding for a German Cell Therapy to Prevent Transplant ... - Labiotech.eu (blog)

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