The GLG Pharma STAT Blog

GLG Pharma STAT 3 Blog

Posted by Richard Gabriel on Wed, Dec 26, 2018 @ 11:57 AM

Welcome the first blog of our new website, GLG Pharma, LLC. We will try to cover a variety of topics related to STAT 3 inhibitors, cancer in general as well as other informative articles that we find on health, nutrition, exercise and cancer prevention and treatment.

Cancer cells, STAT3 and cancer, STAT 3, cancer treatment and STATs

GLG Pharma, LLC is a Florida based company, located in Jupiter, Florida, near the Scripps Institute, Florida Atlantic University and the Max Planck Institute. It has affiliations with and has private equity partnerships with the Moffitt Cancer Center in Tampa, Florida, the Town of Jupiter and the Paragon Foundation of Palm Beach County.

If you want to learn more about our company, give us a call or send us an inquiry. We are happy to answer most questions. Our development plan for our four targeted products is emerging and we will from time to time report on our progress in pre-clinical and clinical development of these novel and exciting compounds for the inhibition of the STAT 3 mechanism in cancer cell metabolism. 

Tags: STAT3, STAT 3 inhibitors, STAT3 cancer, cancer diagnosis, STAT

Why Work on Treatment or Cures for Rare Diseases?

Posted by Richard Gabriel on Wed, Jan 28, 2015 @ 04:15 PM

“Highlighting Chronic Lymphocytic Leukemia (CLL)”

 

CLL, STAT3, GLG Pharma, STAT3 Inhibitors

 

The goal of every pharmaceutical and biotechnology scientist, physician and clinician is to save the patient’s life through an outright cure of the disease and if it can’t be saved then improve the quality of his/her life. Below are definitions of Rare Diseases, according to our friends at Evaluate Pharma[1]:

Evaluate Pharma Excerpt:

“The National Organization for Rare Disorders (NORD), which was instrumental in establishing the Act, currently estimates 30 million Americans suffer from 7,000 rare diseases. Prior to the 1983 Act, 38 orphan drugs were approved. To date, 468 indication designations covering 373 drugs have been approved. The success of the original Orphan Drug Act in the US led to it being adopted in other key markets, most notably in Japan in 1993 and in the European Union in 2000. Rare Disease Patient Populations are Defined in Law as:

  • USA: <200,000 patients (<6.37 in 10,000, based on US population of 314m)
  • EU: <5 in 10,000 (<250,000 patients, based on EU population of 506m)
  • Japan: <50,000 patients (<4 in 10,000 based on Japan population of 128m)

Financial Incentives by Law Include: Market Exclusivity

  • USA: 7 Years of marketing exclusivity from approval. Note: Majority of orphan drugs have a compound patent beyond 7 years. The market exclusivity blocks ‘same drug’ recombinant products, e.g. Fabrazyme (Genzyme, now Sanofi) vs. Replagal (Transkaryotic, now Shire). ‘Same drug’ exclusion can be overturned if clinically superior (mix of efficacy/ side effects), e.g. Rebif overturned Avonex’s orphan drug exclusivity (7 MAR 2002) 
  • EU: 10 Years of marketing exclusivity from approval.

Reduced R&D Costs:  

  • USA: 50% Tax Credit on R&D Cost
  • USA: R&D Grants for Phase I to Phase III Clinical Trials ($30m for each of fiscal years 2008-12)
  • USA: User fees waived (FFDCA Section 526: Company WW Revenues <$50m) 

Methodology on Classifying an Orphan Drug:  

"We, (Evaluate Pharma) have identified all products that have orphan drug designations filed in the US, EU or Japan. These are available as part of the core EvaluatePharma service. To further enhance analysis, we have defined a clean ‘Orphan’ sub-set of products following a number of criteria including:

  • First indication approved is for an orphan condition.
  • Products expected to generate more than 25% of sales from their orphan indications. 

This has led to the exclusion of drugs such as Avastin, Enbrel, Herceptin, Humira and Remicade, all of which have orphan designations for indications contributing less than 25% of sales.

  • Trial sizes, with smaller Phase III trials suggesting orphan status.
  • Drug pricing, higher prices were taken as an indicator of orphan status.
  • All sales analysis in the report is based on this clean ‘Orphan’ sub-set of products.” End of Evaluate Pharma excerpt. 

Chronic Lymphocytic Leukemia (CLL) is considered a ‘rare disease’. A great source of information on CLL[2] is the Leukemia & Lymphoma Society[3] which has over the years poured over $1 billion into research for Leukemia.  The information found in the PDF download (see reference) is excellent and is a foundation for understanding this disease and other leukemia’s as well.  

Some rare diseases have identified mechanisms of action that lay across the biological human horizon of diseases but aren’t as highly expressed or manifest themselves as a chronic lethal disease. One of the mechanisms sometimes associated with proliferative diseases that includes rare forms of cancer, is an abnormality in a major signaling pathway located downstream where many other pathways convey extracellular signals into the nucleus.  This is the case of the Signal Transduction and Activators of Transcription (STAT) and in particular, STAT3.  

At GLG Pharma we have focused on the STAT3 signaling pathway and its uncontrolled hyperactivity. Activation of STAT3 can be blocked at three different sites: 

  • Phosphorylation
  • Dimerization
  • DNA Binding

 STAT3 Inhibitor, STAT3, GLG Pharma, GLG-801, GLG-302

Three drugs are in the development pipeline. The first with the shortest path to the market is GLG-801. This is a repurposed drug and under US FDA rules for 505(b)(2) could be fast tracked for various indications and clinical trials might be initiated, as soon as funds become available, in patients with  rare diseases such as Chronic Lymphocytic Leukemia (CLL) and Gastro-intestinal Stromal Tumors (GIST). GLG-302, a new chemical entity (NCE) follows in the development cycle and is expected to be in the clinic in about 8 months from funding. GLG-202 is another NCE that will follow in the development cycle. GLG-801 inhibits DNA binding and both GLG-302 and GLG-202 inhibit dimerization of the STAT3 molecule, preventing its penetration of the nuclear membrane and the initiation of the transcription process and the continuation of the uncontrolled proliferation process.

Want to know more about GLG Pharma and Poliwogg? Raising awareness and helping us fight cancer! Then click on the Poliwogg picture and it will take you to the Poliwogg accredited investor site!

Poliwogg, GLG Pharma, STAT3 inhibitors, CLL, Chronic Lymphocytic Leukemia

Want to find out more about what compounds are in the clinic for CLL? Then click the button. Once you have signed up, we will email you the PDF document that provides you with compound structures and data on the activity of the compounds as well as their site of action on the leukemia cells!

 CLL in Clinic!

[1] Evaluate Pharma Report “Orphan Drugs 2014” http://www.evaluategroup.com/Default.aspx?goBack=true

[2] https://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/leukemia/pdf/cll.pdf

[3] https://www.lls.org

Tags: GLG Pharma, GLG, STAT3, STAT3 cancer, STAT3 inhibitors, STAT3 inhibitors, Cancer, Cancer, cancer diagnosis, STAT, cancer prevention, Alpha-1, Cancer Therapy, Rare Diseases

GLG Pharma Attending Faster Cures Partnering Nov. 16-18 NYC

Posted by Richard Gabriel on Sat, Nov 15, 2014 @ 02:18 PM

GLG Pharma Attending Partnering For Faster Cure

GLG Pharma will be attending the Partnering for Faster Cures in New York City on November 16 through 18. The program is a matching of entrepreneurs looking for capital, investors and pharma companies looking for new ideas and technologies. The event is also peppered with researchers and patient advocacy groups as well as not-for-profits funding research organizations across a variety of diseases. Along with Richard Gabriel, COO of GLG Pharma, Greg Simon, CEO of Poliwogg will be attending.  In 2003, Mr. Simon along with Michael Milken founded Faster Cures  out the Milken Institute. 

Poliwogg, Greg Simon, GLG Pharma

Greg Simon, CEO; Poliwogg, Inc. 

Faster Cures’s goals are what the name implies, groups of patients, organizations, companies and entrepreneurs seeking a better way to fund Biotech and Pharma discovery programs so that they reach target patient populations sooner rather than later. 

GLG Pharma is raising funds using the new Poliwogg platform. Poliwogg offers private company investment on its site. This is an example of how accredited investors can now democratize their investments across a portfolio of new startup companies. 

“We are really excited about the Poliwogg platform as it offers investors direct access to startup companies such as ours” said Richard Gabriel; “Poliwogg’s platform uses standard SEC and FINRA rules and regulations for investment, it’s easy, secure and the valuations of the companies are in line with what previously only venture capital firms have had access to” Gabriel goes on to say. “For patient advocacy groups that want a direct opportunity to invest or for individuals that also want to invest directly in the development of a technology for a particular disease, Poliwogg offers an exciting and easy way to do it. Investors are able to spread their investments across multiple platforms and multiple technologies in multiple private companies.” 

Gabriel, GLG Pharma, STAT3 Inhibitors

Richard Gabriel, COO; GLG Pharma

Faster Cures features this event as a mean of accelerating drug discovery, development and funding. The new Poliwogg platform allows companies like GLG Pharma to raise capital and also provides a crucial first step to the potential public offerings. The valuation increases of a private company moving to a public offering will then go directly to the investors, employees and entrepreneurs participating in the private funding rounds.

 describe the image

 

 

Click on the Poliwogg!

Tags: GLG Pharma, STAT3, STAT 3 inhibitors, STAT3 cancer, STAT3 inhibitors, STAT3 inhibitors, Cancer, cancer diagnosis, Polycystic Kidney Disease, Cancer Stem Cells

Who is Your Patient Advocate?

Posted by Richard Gabriel on Tue, Jun 03, 2014 @ 01:54 PM

Where is Healthcare Today for Cancer Patients? Who is your advocate?

Patient advocacy is all about having a representative voice in clinical treatment. For Stage 4 cancer patients, the following excerpt is just one example of where clinical care is being directed by groups that are looking to minimize patient treatment opportunities. Bush, who is still a young man, might think differently if he is faced with a life threatening illness. Kierkegaard called it in existential religious terms; the ‘Leap to Faith’ that often occurs for an individual at the death of a parent, spouse, and/or a child or when an individual is faced with imminent death.  You can hear Bush's comments on: 

Jonathan bush of Athena Health. Dec 20, 2013 07:26AM on CNBC’s “Squawk Box” 

"If you cut out stage 4 cancer care, because most interventions shorten your life and makes you more miserable. Cut out all the chronic care [insurance coverage] and offer it [insurance] at $300 and then everything else is an add-on"..." [This quote is excerpted from Bush’s comments on the Affordable Health Care program and insurance and the state of health care in the United States; from his perspective.] 

Jonathan S. Bush (born March 10, 1969) is the co-founder, Chief Executive Officer, and President of Athena Health; a Watertown, Massachusetts based health care technology company founded in 1997.  In 2000, Bush raised more than $10M in venture capital funding to support Athena Health, which launched a successful IPO in 2007. Before founding Athena Health, Bush served as an associate of J. Bush & Company, Inc. and as a consultant at Booz Allen Hamilton, where he was a member of its Managed Care Strategy Group. Bush holds a Bachelor of Arts degree from Wesleyan University and a master’s degree in business administration from Harvard University.  In 1991, during "Operation Desert Storm", Bush served as a Combat Medic in the rank of Private First Class. He is the son of Jonathan Bush, cousin of former U.S. President George W. Bush, nephew of U.S. President George H. W. Bush, and brother of television presenter Billy Bush. Athena Healthcare highlights options for physicians on maximizing reduction in health care costs by recommending alternative treatment options. Today, Athena Health has a market cap of over $1.8 billion dollars. 

While Bush’s views on health care are not universal, the view does highlight what many healthcare pundits say is endemic with the industry, a parsimonious and conservative view of how patients should be treated and how much money should be allocated for their treatment. Groups like Kaiser Permanente offer My Doctor web site filled with information on cancer treatment options http://preview.tinyurl.com/kzcde8t as just one example of patient access to medical information. When a patient is fighting for their life; more information and top notch treatment or access to new therapies in clinical trials are sometimes what can make the difference. But someone needs to pay for that treatment and this is where the battle lines have been drawn. Cost versus treatment and access to treatment. Rich patient advocacy groups have been in existence for some time. A good example is ‘Best Doctors’; http://tinyurl.com/o38tj9m offers supreme ‘concierge’ services for a price. Clearly, “Best Doctors” carry premiums and services that are outside of the Affordable Care Act health care costs and the budgets of most families. Only 23% of their clientele are in the US, all the rest are outside of the US. They are a first rate organization and bring real value to the patients who can pay but that isn’t a model that is supported by the Affordable Care Act and is more in line with the rich will survive, the rest of us, well we have to make do with less. 

While cost savings are important to health care treatment, parsing out money for ‘approved’ and ‘unapproved’ conditions is tantamount to social and economic status engineering where only the wealthy can get the treatment they need and that treatment is only reserved for those patients that can afford it or have access to the networks of professional medical groups that can provide those services to the selected few. 

Also contributing to the lack of good and potentially new therapies for Stage IV cancer patients that could take a patient out of treatment and back into remission is the lack of funding for new therapies. The Affordable Care Act and the Jobs Act combined have created a potential new source of investment capital that is now available for startup companies. Patient advocacy groups can now raise capital using the Jobs Act Regulation D to raise sufficient amounts of capital to make FOR PROFIT investments in startup technologies. 

How Does the Jobs Act – Regulation D 506(c) Work? 

Regulation D 506(C) is an unlimited amount of capital with a limit of 2,500 shareholder/investors until reporting to the SEC regularly (quarterly and with annual audited financials) are required by law. The other restriction is that only persons or families (spouse) with combined incomes over a $300,000 or a net worth, excluding primary residence, of over $1.0MM, qualify as investors under Regulation D 506 (C). According to recent information there are about 8 million people in the US that qualify under SEC rules as “qualified investors” but a vast majority of them either don’t know that they qualify, aren’t interested in qualifying or have never invested in startup companies. It is estimated that less than 500,000 individuals or family units do this kind of private equity investing today. A part of this investing group is now known as ‘angel’ investors, gathering in groups of wealthy individuals and pooling their collective resources to raise initial capital for a startup. The problem with the angel groups today is that the capital initially invested in the drug area is a very small amount of the capital needed to advance a therapy or treatment to human clinical trials. Angel investments are typically in the $1-$3MM range and for that investment could consume up to 40% of the initial equity in a startup company. 

Patient advocacy groups can also organize under an investment moniker to raise capital as a “for profit” entity under the “not for profit” arm of their advocacy groups and begin investment in startup technologies and companies. Using Regulation 506, patient advocacy groups can behave the same way that some venture capital groups have operated for years, using Regulation D as the route of raising new capital for their funds (from qualified rich donors). Patient advocacy groups for example can use a part of their funds to support promising research at their favorite institutions (not for profit function), augmenting National Institutes of Health sponsoring of research. This one-two punch research support of NIH coupled with Not-for-profit grants provides the catalyst for new ideas, concepts and therapies through understanding of primary biological, chemical, structural and mathematical data and systems. In addition, a portion of their raised investment capital (the for profit advocacy group) can be used to invest in new therapies from discovery through New Drug Application approval by the US FDA or other similar regulatory body across the globe.

What Makes a Good Investment Target? 

The only investment target that we know something about is our own development pipeline and we will use this opportunity to provide an example of why a pipeline approach to drug development is a risk lowering strategy; as it is used by the well-financed and operating pharmaceutical and biotechnology companies and often ignored as a strategy for a startup by venture capital. It doesn’t have to be ignored by investors. The restriction of direct investment in startup companies and technologies if you qualify as an investment advocacy group or as a family or individual has been streamlined by the Jobs Act. The good news is that startup valuations in health care are still very low and have not hit the stratospheric pricing for pre-IPO stocks such as DropBox (valued at $10 billion prior to an IPO), a cloud based file sharing company. Most biotech startups are priced in the $10 to $20 million pre-money if they don’t have revenues, if they build revenues or close transactions; the valuation rises but not exponentially, rather more rationally. Usually when a startup gets acquired by a larger company, the valuations are often exponentially increased as pharma companies tend to price in future earnings of the acquired company in a buyout.

According to Life Science Nation (LSN) and its CEO and founder, Dennis Ford “it’s raining investors” in early stage clinical development projects (http://blog.lifesciencenation.com/) and here are two graphs extracted from his blog to highlight the interest expressed by investors who are signed up with LSN. 

Followed by a chart that is the result of one-on-one interviews by LSN staff with the investor group highlighted above:

Lifescience Blog

 

LifeScience 2

This can be good news for startup companies that have pipelines of development products and projects for at-risk patient populations. Reducing risk in early stage development projects in a startup company are crucial to moving a company forward, creating increase valuations for the early investors and completing strategic partnerships to help fill out the gaps in drug development, reducing risk and hopefully producing positive clinical product data. 

Diversity of Revenue Streams! 

When considering an investment in a biotech, early pharma or a lifescience startup; take a look at the product life cycles and depth of product line diversity within the company. In GLG Pharma’s case, we are already internationally diverse. We are negotiating a strategic partnership for drug development and approval of our lead product GLG-302, a p-STAT3 inhibitor that reverses Stage 4 chemotherapy resistant tumors and may allow for additional chemotherapy treatment. Market segmentation by regional partners is a good way to diversify risk and in our case, it provides us with a reliable partner in another part of the world that we would be unlikely to go to in the very near future. Providing your partners with access to your equity, product lines and development pipelines, creates meaningful incentives for shareholder risk reduction. 

An additional deal is underway in Europe, particularly in France where GLG Pharma, SAS is based. The SAS company will license an approved therapy treatment for actinic keratosis (precursor to skin cancer) and sell into France. Additionally, GLG-801, 302 and 202 are being formulated into patent protected formulations for dermatological applications. Our partner in the EU will formulate GMP material, check stability and provide samples to us for early proof of concept treatment under a physician’s Investigational New Drug program. Once proof of concept data confirms our scientific hypothesis, that the drug as a p-STAT3 inhibitor will work, then full clinical development will begin. First approval will be in Europe and the two companies will partner the drugs across the globe. GLG Pharma, SAS retains rights for France; our partner has rights for Germany, Austria, and Swiss speaking Switzerland, Japan and the UK. All other countries are partnered with a 50-50 split of profits. 

GLG-801 is a repurposed drug (already approved in another indication) that will have a faster time to market with the new skin formulation. The next product will be GLG-302, a New Chemical Entity. Following closely behind GLG-302 will be GLG-202 a rationally designed, composition of matter drug candidate. In addition, GLG Pharma has a diagnostic to monitor p-STAT3 during clinical and following drug approvals. Combining drug therapy and p-STAT3 diagnostic as well as other clinical marker monitoring, can perhaps reverse drug resistant tumor cells and make them more vulnerable to additional chemotherapy treatment! 

The GLG Pharma Pipeline 

Graphically we can represent the pipeline several ways:

STAT3 inhibitor pipeline

 

Diversifying a product pipeline across different diseases is also a way of reducing risk.

STAT3 Inhibitors

 

In addition, combining the strategy of ready to go to market products helps the company become an integrated company that has all the elements of a larger, fully funded pharmaceutical or biotech company with global initiatives and partners. Developing products within the treatment market for diseases is a global team effort, requiring a cross section of expertise usually not found in one single startup management team. While the GLG team has over 110 years of combined experience and has 15 approved drugs and 30+ diagnostics in the market, the core team still requires additional team members to advance its risk reduction strategy. Want to learn more about making a difference? Go to Poliwogg or visit our web site at GLG Pharma. We’ll also be at the International Bio Conference in San Diego partnering away!

Tags: GLG Pharma, STAT3, STAT 3 inhibitors, STAT3 cancer, STAT3 inhibitors, Cancer

Why is GLG Pharma Different?

Posted by Richard Gabriel on Thu, Jan 02, 2014 @ 10:28 AM

Logo 5 24 13a resized 600

The most important difference is that GLG Pharma are not starting from scratch. We are veterans of many drug discovery, development, launch and successful drug treatment products. Many new companies that were launched and are being launched today in the Biotech and Pharma markets; were and are, started with such marketing and funding concepts as:

  • Transformational (new technology that changes an application within a defined market and industry)
  • Paradigm Shifting (new technology that changes an industry)
  • Innovative Transformations (new applications that open new markets of established market, technology and industry)
  • Ground Breaking Technologies (never before discovered technologies that opens completely new markets)
  • Lots of Investment Capital (Drugs, devices and diagnostics all require large amounts of capital)
  • Lots of equity dilution (founder’s equity is usually reduced to 1-5% of holdings after IPO’s, as a general rule)

GLG Pharma was started with a much simpler and understandable strategy for achieving drug and regulatory approval, a strategy that has two principles. Know your science and know your patient, coupled with shorter to market revenue generating products.

Many drug companies today have that strategy, but they are already funded. These companies are now selling products into a market and now they have become post-transactional savvy, compared to when they were first funded or seeking investment. So what has changed in the Biotech and Pharma world? In our opinion, a lot has changed.

Pharma and Biotech companies and startups have evolved as have the Pharma and Biotech markets in which we all operate. Today, investment for transformational, paradigm shifting and ground breaking technologies out of the high end institutions is still happening and will continue to do so; but the real question is; is this how a new Biotech and Pharmaceutical company should be launched? There is a reduced risk way to fund Pharma and Biotech. At GLG we have combined near term revenue opportunities in cancer with our pipeline development strategy. Our focus remains on the science and the patients, supported by investment and revenue from targeted approved products for prescription and over the counter products. These early stage revenue generators can help fuel and reduce the need for additional investment and subsequent dilution.

Each disease, whether it is AIDS, Influenza, Cancer, Schizophrenia, Alzheimer’s, Autosomal Dependent Polycystic Kidney Disease or any other terminal or chronic illness, have families and friends concerned for the patient. The patient is attended to by a cadre of physicians and clinicians who manage the disease and its treatment. It is a very complicated and sometimes a frustrating process, especially in the United States and also in Europe. It is frustrating not only for the patients and their families, but also for startup companies and entrepreneurs who want to launch new products and therapies for those patients. GLG’s focus on the science of disease and a patients therapy in treating proliferative diseases that have p-STAT3 as a mechanism, could help usher in new lower toxicity drugs that improve overall patient care. GLG can also monitor p-STAT3 levels in patients with a disease, alerting clinicians and patients as to the success or failure of a treatment regime.

Since the second great depression; starting in 2007 with the hedge fund collapse, life science technology companies; especially the Biotech and Pharma industries have been declining in value. However, the decline shortly after 9/11 in 2001; drug, biotech and diagnostic stocks and the startups have been on the proverbial slide down the slippery slope of little to no liquidity. Low liquidity for investors, low liquidity in equity markets, little to no availability of capital in bond markets. Adding to the downward spiral is the apparent unending series of regulatory disasters that have left the investment community shying away from anything remotely represented by or requiring an FDA filing and approval. Part of the regulatory perception problem was caused by large Pharma and large Biotech, by sometimes ignoring their responsibility to self-regulate their products, operations and clinical development in accordance with FDA and EMA regulations. A few very visible FDA actions against the industry can affect the entire investment and market landscape, Vioxx, Genzyme’s production failures and a whole host of other disasters, tangibly affected the investor psyche.

GLG’s management team have a performance history; out of the 16 drugs that have been developed and submitted to FDA review and approval by our collective team of professionals and the several FDA site audits of our former operations, 15 of those drugs were approved and none of us received or were cited in a FDA audit for any violations of 21CFR guidelines.

The same principle of respect for the regulatory process, applies to our respect for the patients; that our drugs will be treating. GLG are looking for a series of molecules that will be efficacious for the treatment of patients and have as little side effects as possible. All drugs have side effects that affect some or all patients, so having a chemotherapy agent that does not have side effects are rare. So why did we choose GLG-302, GLG-801, GLG-202, GLG-101 and 401 to advance into clinical development. GLG-302 is a compound that has proven itself in our pre-clinical evaluations as well as by a host of independent laboratories around the world. We have encouraged other laboratories to duplicate our findings and we have built up a successful and prominent following of researchers that now believe that inhibition of p-STAT3 is one of the keys to shutting down cancer cells that have become resistant or are proliferating at an exponential rate.

We are also looking at GLG-302 in combination with other standard chemotherapy agents as this compound has reversed chemotherapy resistant cells in vivo and in vitro, allowing a second course of treatment which eradicates the resistant tumors. This research has also led us to study cancer stem cells which survive standard chemotherapy treatments, these cancer progenitor cells go into a sort of remission and then spread throughout the body and start reproduction at a much higher rate. Cancer stem cells are resistant to chemotherapy treatments and are believed to be one of the major cause for cancer cell metastases. Cancer stem cells appear to be 100% up regulated with p-STAT3.

 GLG Pharma: Drugs, Diagnostics and Devices- delivering more than a drug ©

 

Tags: GLG Pharma, STAT3, STAT 3 inhibitors, STAT3 cancer, STAT3 inhibitors, Cancer, cancer diagnosis, STAT, cancer prevention, STAT3 mechanism

GLG-302 Selected by NCI for Funding in Cancer Prevent Program

Posted by Richard Gabriel on Wed, Jul 24, 2013 @ 12:45 PM

GLG Pharma’s STAT3 Signaling Inhibitor Selected for NCI’s PREVENT Cancer Preclinical Drug Development Program.


Jupiter, FL. July 16, 2013 – GLG Pharma, LLC announces scientific and financial resources of the PREVENT Cancer program of the National Cancer Institute of the NIH have been approved to study the effects of its STAT3 signaling inhibitor, GLG-302 as a breast cancer chemopreventive. The PREVENT Program is a National Cancer Institute-supported pipeline to bring new and novel cancer preventing interventions and biomarkers through preclinical development towards clinical trials.
The selected GLG Pharma study entitled “Evaluate GLG-302 in the Prevention of Mammary Cancers in the ER(+) Methylnitrosourea Rat Model and the ER(–) MMTV-NEU Mouse Model” using well established models of breast cancer will focus on the following areas:
1) Evaluate the MTD, effect on STAT3 in normal mammary tissue and oral efficacy of GLG-302 in mouse models of breast cancer.
2) Assess effects on tumor latency, incidence, multiplicity, and body weight.

This key study is an in-depth continuation of preliminary studies already conducted by GLG Pharma. In these studies GLG-302 was shown to suppress tumor growth in a number of animal models, to have a wide therapeutic index and was well tolerated.

In recommending approval of resources for the project, the PREVENT panel of external experts observed “This pathway is implicated in multiple cancer types. The value of the study goes beyond validating the pathway.”
According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, breast cancer is the most common cancer among women in the United States. It is also one of the leading causes of cancer death among women of all races. In the US in 2010, over 200,000 new cases and more than 40,000 deaths due to breast cancer occurred. The greatest achievement for this disease would be to treat high risk women who don’t have detectable breast cancer with an agent that is safe and well tolerated, and would prevent malignant conversion of normal breast cells to cancer.
Hector J. Gomez, MD, PhD, Chairman and CEO of GLG Pharma commented: “The NIH grant confirms the high level of scientific interest and the significant potential of our patented STAT3 signaling inhibitors in cancer prevention. This research program will provide important findings and form the basis for further evaluation and development of new therapeutic and chemopreventive agents in the prevention of breast and other cancers”. STAT3 inhibitors are important targets for cancer prevention and cancer treatment. Developed in collaboration with the Moffitt Cancer Center in Tampa, FL along with a companion diagnostic test, STAT3 targeting and monitoring is a program that the NCI has spent significant early research money to evaluate and advance. GLG is advancing these discoveries to the clinic and approval.

Landing GLG Pharma

About GLG Pharma
Founded in 2009 and located in Jupiter, Florida, GLG Pharma, LLC is a privately held, early stage, biotechnology company developing personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://www.glgpharma.com

Tags: GLG Pharma, STAT3, STAT 3 inhibitors, STAT3 cancer, STAT3 inhibitors, Cancer, cancer diagnosis, STAT, cancer prevention

Startup Funds Still Available! Matching Grant for Investment in Cancer Drug Development.

Posted by Richard Gabriel on Thu, Jun 07, 2012 @ 11:02 AM

Institute for the Commercialization of Public Research Funds Jupiter Biotech Company

GLG Pharma Approved for Seed Capital Accelerator Program

Boca Raton and Gainesville, FL – June 1, 2012 - The Institute for the Commercialization of Public Research (the Institute) announced today that it has provided early-stage funding to GLG Pharma (GLG), a Jupiter-based company developing treatments based on technology licensed from the Moffitt Cancer Center in Tampa, for cancer and other proliferative diseases wherein cells grow or multiply rapidly. The Institute works with Florida’s research universities and institutions to support new company and job creation, and participants in the program must match Institute funding with private capital raised from angel investors and other sources. 

GLG Pharma is developing a series of patented inhibitors of activated Signal Transducer and Activators of Transcription 3 (p-STAT3).  The p-STAT3 protein is encoded by the STAT3 gene and is unique in the ability both to respond to extracellular signals and to regulate other genes directly.  In normal cells, the formation of the p-STAT3 protein is switched on and off in response to signals that control cellular function.  The presence of persistent levels of p-STAT3 is thought to play a key role in a number of diseases including cancer, psoriasis, polycystic kidney disease and Crohn’s disease.  GLG Pharma’s initial therapeutics are expected to aid in the  treatment of a wide variety of cancers with potentially greater efficacy and significantly fewer side effects than existing therapies in the $75-80 billion anti-cancer market.

GLG’s Executive VP Michael W, Lovell, Ph.D. stated that “this funding will enable us to advance the development of three product candidates and expand our collaborations with other research institutions in Florida. We appreciate Florida’s commitment to advancing the Life Sciences sector and these funds will enable us to raise additional capital to support our product commercialization efforts.”  

 “Companies like GLG Pharma demonstrate the promise of a diversified, knowledge-based economy in our state, and we are pleased to offer programs that help early-stage companies such as GLG Pharma achieve critical development milestones, said Jamie Grooms, Institute president and CEO.  “GLG Pharma also represents the statewide connectivity provided by the Institute, which facilitated bringing together technology from West  and Central Florida, management from Northeast Florida, and funding from Southeast Florida.”

About the Institute

Founded in 2007 as a non-profit organization, the Institute is Florida’s One-Stop-Shop for investors and entrepreneurs who seek to identify new opportunities based on technologies developed through publicly-funded research.  The Institute delivers programs that facilitate new venture and job creation through commercially-viable technologies in major industries that are driving the global economy.  The Institute also administers the Florida Research Commercialization Matching Grant Program launched in 2010, and the Seed Capital Accelerator Program launched in 2011.  For more information, visit .

About GLG Pharma

Located in Jupiter, Florida, GLG Pharma, LLC is a privately held, early stage, biotechnology company founded in 2009 to develop personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://glgpharma.com

Tags: GLG Pharma, STAT3, STAT 3 inhibitors, STAT3 cancer, cancer diagnosis, STAT

STAT 3 publications are numerous and we hope that the following links will help you better understand it's importance in cancer cell metabolism and cancer cell death. Inhibiting STAT 3 is an important mechanism for encouraging cancer cell death. Using STAT 3 inhibitors with other traditional cancer chemotherapy should help improve patient outcomes. Linking a diagnostic with a STAT 3 inhibitor will also help reduce patient side effects as well as potentially improve patient outcomes.