A pill for lymphedema? Talking ubenimex’s potential with Dr. Quan of Eiger BioPharmaceuticals

How exciting would it be if we could just take a pill to get rid of our Lymphedema… great research ..thanks Alexa for keeping us up to date

The Lymphie Life

Living with lymphedema can be a real pill — but what if it could be treated with one?

Recent studies indicate it’s possible, and may even be a reality sooner than we think thanks to clinical trials of a drug called ubenimex.

Last summer I wrote about the ubenimex trials, which at the time of writing had just kicked off by dosing their first patient. The news generated a huge response from the lymphedema community — one of hope, excitement, and lots of curiosity — so I’m back with an update!

Photo courtesy Dr. Quan.

I recently had the incredible opportunity to speak with Dr. Joanne Quan, Chief Medical Officer at Eiger BioPharmaceuticals, a biopharmaceutical company focused on the research, development, and commercialization of therapies for orphan diseases; they are also sponsoring the ubenimex clinical trial.

Dr. Quan and I talked about the ubenimex trial, the Stanford…

View original post 1,393 more words

Research

imageFirst Patient Dosed in Secondary Lymphedema Study
Andrew Black
Published Online: Monday, Jul 25, 2016
30 700 5 4
Eiger BioPharmceuticals dosed the first patient in the Phase 2 Ultra Study of their drug Ubenimex in patients diagnosed with secondary lymphedema. The Ultra study is designed to assess the effectiveness of ubenimex blocking the production of Leukotriene B4 (LTB4).
Ultra Study
The study will evaluate the effects of ubenimex in patients with secondary lymphedema of the lower limb(s) who are optimized on physical therapies. The Ultra Study is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial assessing 40 patients that will be randomized to receive either 150 mg of ubenimex or placebo three times a day over 24 weeks.

Leukotriene B4 (LTB4) is a naturally-occurring inflammatory substance known to be elevated in both preclinical models of secondary lymphedema as well as human lymphedema disease. Elevated LTB4 causes tissue inflammation and impaired lymphatic function. Targeted pharmacologic inhibition of LTB4 promotes lymphatic repair and reverses lymphedema disease in treated animals.

Ubenimex is an oral, small-molecule inhibitor of leukotriene A4 hydrolase, which regulates the production of leukotriene B4 (LTB4), an inflammatory mediator implicated in PAH. LTB4 is produced from leukocytes in response to inflammatory mediators and is able to induce the adhesion and activation of leukocytes on the endothelium, allowing them to bind to and cross it into the tissue.

Ubenimex is also currently being evaluated in a Phase 2 study for the treatment of Pulmonary Arterial Hypertension (PAH).
Secondary Lymphedema
Secondary lymphedema usually develops as a result of a lymph vessel blockage or interruption that alters the flow of lymph through the lymphatic system and can develop from an infection, malignancy, surgery, scar tissue formation, trauma, radiation, or other cancer treatment Radiation therapy can damage otherwise healthy lymph nodes and vessels, and can cause scarring of the lymphatic vessels which leads to fibrosis and subsequently diminish lymphatic flow.

 

Always excited to see any research into treating and curing Lymphedema …

Research… Lymphedema

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To find a cure for Lymphedema there needs to be research.. This information was sent to me by a reader via a comment and I thought it may be interesting to you all…

“There is a future treatment that I don’t see tracked in the past postings in your blog. I think it’s something that your readers may find intriguing. The potential treatment involves a form of retinoic acid. To put a very general label on retinoic acid, it is associated with vitamin A and as a layman I can’t embellish the specific differences. What is clear is that some experimentation is bringing to light favourable aspects of retinoic acid. A few papers have been published on beneficial aspects of a very specific variation of Retinoic acid called 9-CIS. In 2012 a published a paper in the American Heart Association publication Circulation showed a very favourable improvements in lymphatic function with mice as the recipients. That paper is available in its entirety at the first link below. At that time, I was surprised that this paper did not bring about a trial. Instead, there was much skepticism and a counter editorial published in that same issue of Circulation. It appears that the authors of that paper continued experimentation and recently published additional findings on 9-CIS. The second link is for the new paper which is only available as an abstract at this time. Again, the results for 9-CIS were quite positive and repeatable.

As you will see if you read the paper, 9-CIS is already approved by the FDA as a treatment for other diseases. This means an extensive amount of testing and data is available about this drug. Of course, there is uncertainty and risk with any human trial, but a drug that has already obtained certification for use on humans is not such an unknown. Because LE day approaches there may be a small spike in the topic. I often wonder if a grassroots request effort from LE sufferers would aid in accelerating trials for treatments for LE.”

Thanks Paul for this interesting information .. We hope that as time goes by there will be more and more research into a cure for Lymphedema… It is much needed by all those that live with this  24/7

http://circ.ahajournals.org/content/125/7/872.abstract

http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Prevention_

of_Postsurgical_Lymphedema_by_9_cis.97188.aspx

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3357957/

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Sometimes life does not go as planned!!

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I am sure that those of you who have followed my blog over the past couple of years will wonder why I have not done an update of my own progress. March 2015 was the two-year anniversary of my Lymph node transfer and I am very happy with the results, not a cure at this stage but a huge improvement. There will be more on this later…

The reason for my lack of posting is I have been very ill with another late stage effect of radiation and cancer treatment. I started to experience weakness in my legs, I had falls, my legs felt numb combined with pins and needles,(peripheral neuropathy) gradually it became harder to get up stairs and to walk in general. December 2013 was my first appointment with a neurologist…. 2014 was a very difficult year, full of doctors appointments many, many tests, scans, a biopsy, neurological tests etc. I was seen by two neurologists, an immunologist and also visited a Clinic that specialized in Functional medicine.( Combining alternative medicine and conventional medicine).By the end Of 2014 I was given the diagnosis of Radiation Induced Lumbar Plexopathy, a very, very rare and untreatable side effect of radiation that leads to paralysis of the legs due to damage to the nerves in the Pelvis. http://emedicine.medscape.com/article/316604-overview#a0101 Women who have had Breast cancer treatment can get Radiation induced Bracheal Plexopathy which leads to weakness or inability to use the arms and hands.

The first three months if this year was spent in hospital, doing intensive neurological rehabilitation, in the hope of regaining the use of my legs. Sadly this did not happen. While in hospital I learnt to use a wheelchair, and everything else I would need to manage with paralysed legs. We have had to sell our house and we will be moving into a home that is wheelchair friendly. Thank goodness for the help of those physios and occupational therapists who got my life back on track while I was in hospital. You can imagine there has been many tears coming to terms with this and I never imagined I could have something healthwise that was worse than the Lymphoedema!!!

It is very hard for me to write this, only 0.16% in 1000 of those who have had pelvic radiation  get this side effect. It can happen from 0-30 years after the radiation. It is difficult to get information and to connect with others but via the internet and the American Cancer Society I have connected with a couple of ladies. This is certainly not something they tell you about when you are having Radiation!!! No I am not starting a new blog at this stage, or trying to build awareness of this side effect!!! All my energy goes to getting through each day and learning to live with my new “normal”.

However even with all this the Lymphoedema journey still continues with I feel good results. Due to my illness I had to withdraw from the research program at Macquarie University Hospital Sydney as I could not have the MRI or Lymphoscintigram done. The measurements would also all be effected due to the muscle wasting of the legs, due to lack of movement. Since the start of the year I have not worn compression stockings, they are difficult to get on and uncomfortable on the sensitive nerves in my legs. Surprisingly my legs have stayed really good without compression. They are soft all the time, a bit of swelling in the ankles goes down over night and I have had no cellulitus since the surgery in March 2013… My lower leg is the same size as my good leg and the thigh a little bigger but does not get worse. Maybe a transfer to the groin as well as the one to the knee would have helped this but there will be no more surgery for me now!!!!

One of the things that is important for Lymphoedema is movement so on the recommendation of the rehabilitation doctor in the hospital I got a MotoMed machine http://abilityinmotion.com.au/products/movement-therapy/motomed/ This has been the best thing I could have done for the Lymphoedema and for my paralysed legs as it keeps the muscles moving and keeps the circulation going. I am unable to peddle, so the motor kicks in and I can do 25km of passive exercise plus I usually do 5km of active exercise, with my arms, for the upper body. This and deep breathing every day helps to keep my Lymphoedema in order, plus I elevate the end of my bed at night to help any swelling. Even the ankle on my good leg swells a bit sitting in a wheelchair all day, so there is double reason to look after my circulation.

I intend to keep this blog going and to share people’s stories and their progress. It has become quite a useful resource for those going ahead with surgery for Lymphoedema. Over the past two years I have noticed an increase in those having LNT and Lymphatic Bypass surgery, LVA, plus Lymph sparing liposuction to help their Lymphoedema, in both arms and legs. I think we are yet to find a 100% cure but there appears to be improvement, how big the improvement depends on the condition of the limb pre surgery and the care given post surgery. It can also take a number if years to see the ultimate response to surgery. Please keep sending me you stories and adding your comments to the posts, it is this sharing of knowledge that helps. Of course non of this replaces the advice of the surgeons who are looking after you, I am also glad to see that some of them are collect data on their results.. This is so important for the future…

Thank you to all of you who have supported me in the past year and who were aware of my problems, you have made it all a little easier to get through. Everyday for me is now a new experience……

If you would like to contact me please send an email to helenbrd@bigpond.net.au

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Brooklyn Bridge walk with The Lymphatic Education and Research Network

Walking the Brooklyn Bridge

Walking the Brooklyn Bridge

I was invited by the Lymphatic Education and Research Network to write a guest post on the importance of education and research for Lymphedema and the funds that are needed  to support their goals. On September 14th there will be a sponsored walk across the Brooklyn Bridge which is hoping to raise $60,000.

This is a link to my post…..
http://lymphaticnetwork.org/news-events/lymphedema-a-light-in-the-darkness-by-helen-bonynge

This is a link to more information about the day and how you can help raise much-needed funds…

http://lymphatic.donorpages.com/LYMPHWALK2014/

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Help to guide the growth of lymphatic channels

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I am always so excited with any new research to help Lymphoedema, even if I find it difficult to understand it is truly wonderful to see!!! This article was sent to me about “artificial” tissue that can be used during a Lymph node transfer to help in the development of Lymphatic Channels. It has been tested by Dr Corrine Becker and maybe available for use in 2015. “We anticipate that BioBridge will initially be used as an adjunct to Vascularized Lymph Node Transfer, an existing surgical procedure used for treating lymphedema. Our expectation is that BioBridge will help improve the outcome of this procedure. We are working closely with Dr. Corinne Becker, who pioneered this surgical procedure.” Quote from Greg King

Interview with Greg King, COO of Fibralign, Winner of 2014 MedTech Innovator

by JUSTIN BARAD on Jul 17, 2014 • 3:31 pm

Fibralign, a startup medical device company, just took home the grand prize in the 2014 MedTech Innovator competition, winning over 267 other startups. Their product, Biobridge, is a possible cure for secondary lymphedema, a debilitating disease with few available treatment options. Secondary lymphedema describes a condition in which the lymph system, which is responsible for removing extracellular fluid, is disrupted, resulting in the accumulation of extracellular fluid. This can lead to swelling in the extremities, which can cause significant discomfort and is cosmetically unappealing. This condition is most commonly associated with breast cancer patients who sometimes must undergo aggressive lymph node dissections in the armpit in order to stage their cancer, but it can happen in any condition in which the lymph system has been disrupted.

BioBridge

BioBridge

The Biobridge is an implant that has been shown to be able to guide the growth of new lymph channels. This technology can be used as an adjunct to existing treatments for the condition to hopefully improve outcomes.

The product itself is a collagen scaffold with very unique properties. “Scaffold” is a term used in tissue engineering that describes a three-dimensional material that encourages cells to attach and grow along its microscopic structure. While collagen scaffolds are not particularly unique, the Biobridge uses a novel fabrication method that gives it a distinctive three-dimensional structure that is very similar to collagen structures found within the body itself.

We had a chance to sit down with Greg King, the COO of Fibralign, to ask him some questions about this very exciting technology.

Justin Barad, Medgadget: Can you discuss the development of your technology? How did it start and when did you start seeing its potential?

Greg King: Our founders had a “penicillin moment” working in a Stanford Lab when they found that previously developed technology for working with liquid crystal materials used in the flat panel display industry could be applied to several biomaterials including collagen in a liquid crystal state to form 3D scaffolds. When they saw the resulting structure in the AFM image shown below they recognized that they had a breakthrough discovery. The image was like the skin scaffold of a newborn, with bundles of highly aligned collagen fibrils. As far as we know, this was never produced before in a lab. They were able to take collagen, a material commonly used for the past 30 years in various cosmetic and surgical applications, and fabricate scaffolds that mimicked different types of human tissue at the micro structural level. They started working with different research groups on a wide range of high-value tissue applications and used this experience to develop the core technology. They determined rather quickly that this was a fundamental technology that offered a large design space for addressing application requirements.

Medgadget: Can you tell us a little bit about when and how your company was founded?

Greg King: The company was founded in 2007 by Michael Paukshto, David McMurtry, Yuri Bobrov, George Martin and Eric Sabelman. They early years were lean, surviving primarily on sweat equity and some modest angel funding. During this time, the team developed its core technology, fabricated initial prototypes and secured an IP position and developed the manufacturing approach for scaling commercially. At the end of 2012, the Company made a business decision to focus on lymphedema as the initial product, expanded the core team and then moved from an incubator to a dedicated lab space with a cleanroom to support this development effort. Fibralign also benefited from grants from the DoD and NSF to support a large animal study and develop production tools for making its initial product. Can you tell us a little bit more exactly how BioBridge is used to treat secondary lymphedema? What results have you had so far in your animal studies?Secondary lymphedema can occur when the body’s lymphatic system is compromised from a trauma. In western countries this most commonly occurs after aggressive cancer treatments, involving surgery and radiation therapy, but it can also occur from infections and other injuries. This can disrupt the flow of lymphatic fluid in the affected limb that leads to swelling, great discomfort and serious infections.BioBridge is a bundle of small collagen fibrils aligned in one direction. It is made from medical-grade collagen and has been designed to support and repair the diseased tissue area, allowing new lymphatic vessels can form in the direction of BioBridge and restore function.In our successfully completed large animal study, we were able to show that new lymphatic vessels formed in diseased areas and about a 60% reduction in accumulated fluid only three months after BioBridge implantation. This compared to the control group that did not get BioBridge and showed no improvement.

Medgadget: What kind of effect will winning Medtech Innovator have on your company?

Greg King: We hope it helps attract attention needed for Fibralign to address this opportunity, providing visibility to investors, stakeholders and the broader community. We need to build awareness of what we’re doing to help treat this horrible and neglected disease, which impacts millions of people and currently has no cure.

Medgadget: Do you have any rough estimate when your product might come to market?

Greg King: We expect to have product in the market in 2015

Medgadget: What sort of clinical applications to you envision for the near future?

Greg King: We anticipate that BioBridge will initially be used as an adjunct to Vascularized Lymph Node Transfer, an existing surgical procedure used for treating lymphedema. Our expectation is that BioBridge will help improve the outcome of this procedure. We are working closely with Dr. Corinne Becker, who pioneered this surgical procedure.

Medgadget: Do you have any advice for our readers, many of whom are aspiring medical innovators and entrepreneurs?

Greg King: Pick something you’re passionate about because it will consume you and require tremendous energy to get anywhere. So make sure you like what you’re doing. Also get out and talk to your expected customers and test your hypothesis and product plans as early and often as you can. It sounds cliché, but this for some reason isn’t done enough in startups and in biotech in particular. Go out and validate your market opportunity before you commit effort and resources!

Greg King

Greg King

http://www.medgadget.com/2014/07/interview-with-greg-king-coo-of-fibralign-winner-of-2014-medtech-innovator.html

Feel free to share with others. It can be distributed via social media, reblogged or added to websites. Please do not change the original content and provide appropriate credit by including the author’s name and a link to this blog.
https://lymphnodetransplant.wordpress.com/ Thanks

Research from Australia which may help those with Lymphoedema

Gene discovery points to lymphatic disease and cancer therapy

This is a link to a television program shown on Chanel 7 about the work that is being done at the University of Queensland on the lymphatics system.

These are links to three articles about the research

http://www.imb.uq.edu.au/index.html?page=211438&pid=12193

http://www.imb.uq.edu.au/index.html?page=210555&pid=12193

http://www.imb.uq.edu.au/ben-hogan

Wonderful to see this research happening in Australia which could benefit those with Lymphoedema and also help to stop the spread of cancer from a primary growth.. Thanks to the University of Queensland for sharing this news..

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Research from Japan brings hope……. Medication to treat Lymphedema!

imageThese are copies of two press releases sent out by Pharmaceutical company AnGes MG, Inc in 2012. One is to patent the medication Collategene for treatment of Lymphedema, the other is to initiate the first world trials on Gene therapy (Collategene) for Lymphedema, these trial are initially for Primary Lymphedema. I do not pretend to understand how this all works! There is so little help for Primary Lymphedema as few are suited to lymph node transfer surgery due to lack of nodes in their bodies, which means there is no safe area to harvest nodes to transfer, which leaves liposuction and debulking procedures.

I do note however, that these press releases state they have also worked out how many people have Lymphedema world-wide, and are thinking about how much profit can be made from this drug!! Well I guess that is ok if it has pushed them into putting their money into research, at last, for Lymphedema, as it has been so neglected  in the past. We hope that years to come people will benefit from this medication. It seems like a dream now but there is always hope.
imageFOR IMMEDIATE RELEASE

October 1, 2012 AnGes MG, Inc.

New Medical Use Patent for HGF Granted in Japan for Lymphedema

AnGes MG, Inc. (“AnGes”) is pleased to announce that a medical use patent has been granted in Japan for HGF plasmid drug which promotes lymphangiogenesis, and the Patent Gazette (JP5036057) has been issued.
The patented invention features therapeutic agents which contain HGF plasmid as an active ingredient and promote lymphangiogenesis, and is administered directly into the affected or peripheral area by intramuscular injection. This patent, along with the previously granted patent JP4111993 for therapeutic agents that prevent or treat lymphedema, protects the new treatment of lymphedema using HGF plasmid from various aspects.
Lymphedema is an intractable disease in which impaired lymphatic system causes severe swelling and fluid retention in limbs by preventing lymphatic fluid from returning to lymph vessels. There are two types of lymphedema: 1) “primary lymphedema” which the pathogenesis is unknown, and 2) “secondary lymphedema” which occurs due to aftereffects of lymph node dissection in e.g. cancer surgery. The existing treatment for lymphedema is mainly focused on complex decongestive therapy by massaging the affected limbs and using compression garments. However, this treatment is symptomatic and should be continued throughout the life. Furthermore, there has been an increase in lymphedema cases among elderly patients in recent years who are unable to perform physical treatment on their own. For these reasons, a development of a new treatment for lymphedema is highly desired.
AnGes has been developing HGF plasmid “Collatege®” for the treatment of Critical Limb Ischemia and now started the research development of lymphedema treatment utilizing Collategene®’s action to promote lymph vessel formation. The confirmation was received from the Ministry of Health, Labor and Welfare (MHLW) on July 18, 2012 that clinical trial plan of Collategene® in lymphedema complies with the guideline for confirmation application, and AnGes’s IND application for Collategene® as a treatment for lymphedema was accepted by Pharmaceuticals and Medical Devices Agency (PMDA) on July 30. AnGes is now taking necessary procedures to initiate the clinical trial.
The grant of this patent enables AnGes to further strengthen the new treatment approach for Lymphedema using HGF plasmid, and strongly supports the development project for a long-term. AnGes strives to obtain medical use patents for other applications of HGF plasmid in order to further strengthen its patent network.
This trend will have no effect on the business performance for the fiscal year of 2012. ###
Disclaimer: This is a translation of the news release posted in Japanese. In case of any deviations between the two language versions, the original document in Japanese shall take precedence.
AnGesMG,Inc.
Corporate Communications TEL:+81-3-5730-2461, FAX:+81-3-5730-2635 http://www.anges-mg.com Email:info@anges-mg.com

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FOR IMMEDIATE RELEASE

AnGes MG Submits an IND Application for CollategeneTM (HGF DNA Plasmid)

July 30, 2012 AnGes MG, Inc.

– Initiation of the World’s First Clinical Trial on Gene Therapy for Lymphedema –

AnGes MG, Inc. (“AnGes”) announced today that their IND application for CollategeneTM (HGF DNA Plasmid) as a treatment for primary lymphedema has been accepted by Pharmaceuticals and Medical Devices Agency (PMDA).
The clinical trial is planned to ensure Proof of Concept (POC) study for primary lymphedema and is the first Phase I/II trial to be conducted with patients. In this trial study, CollategeneTM will be administered intramuscularly to patient’s affected legs which are swollen by more than 20% compared to the healthy legs, and the changes to the volume of edema will be assessed to investigate safety and efficacy of CollategeneTM.
Lymphedema is an intractable disease in which compromised lymphatic system causes severe swelling and fluid retention in limbs by preventing lymphatic fluid from returning to lymph vessels. There are two types of lymphedema: 1) “primary lymphedema” which the pathogenesis is unidentified, and 2) “secondary lymphedema” which occurs due to aftereffects of lymph node dissection in e.g. cancer surgery. The existing treatment for lymphedema is mainly focused on complex decongestive therapy by massaging the affected limbs and using compression garments. However, this treatment is symptomatic and should be continued throughout the life. Furtheremore, there has been an increase in lymphedema cases among elderly patients in recent years who are unable to perform physical treatment on their own. For these reasons, a development of a new treatment for lymphedema is highly desired.
Development for the treatment of Critical Limb Ischemia using CollategeneTM has been ongoing at AnGes and now the research development of lymphedema treatment utilizing CollategeneTM’s action to promote lymph vessel formation has begun. With the confirmation received from the Ministry of Health, Labor and Welfare (MHLW) on July 18, 2012 that clinical trial plan of CollategeneTM in lymphedema complies with the guideline for confirmation application, AnGes is ready to initiate the clinical trial for lymphedema treatment with CollategeneTM, the world’s first effort in treating lymphedema utilizing lymph vessel groth function. That being said, CollategeneTM has a potential to become a radical treatment.
AnGes plans to initiate the clinical trial promptly after taking necessary procedures, and strive to pursue the development in order to provide the new treatment for patients who suffer from lymphedema.
Once the company completes the POC clinical trial with patients with primary lymphedema, AnGes plans to start with the development for secondary lymphedema. It is reported that secondary lymphedema occurs in about 30% of patients who underwent uterus cancer surgery, and 50% of patients who underwent breast cancer surgery. Based on these figures, it is estimated that more than 1 million patients are suffering from lymphedema in seven major industrialized nations, with an approximate market size of 50 billion yen a year.
This trend will have no effect on the business performance for the fiscal year of 2012.
(Reference)
Gene Medicine
###
A drug which utilizes gene or a part of gene as active ingredient.
HGF(Hepatocyte Growth Factor)
A growth factor developed from hepatocytes; in addition to blood vessel regeneration, it initiates various processes necessary for tissue / organ regeneration during organ formation (organogenesis).
Lymphedema
Lymphedema is an intractable disease in which compromised lymphatic system causes severe edema in limbs by preventing tissue fluid from going back to lymph vessel, causing it to be retained under the skin. There are two types of lymphedema; 1) “primary lymphedema” which the pathogenesis is unidentified, and 2) “secondary lymphedema” which occurs due to aftereffects of lymph node dissection in cancer surgery, etc. There is no effective treatment method established for lymphedema while it chronically progresses and is exacerbated over time, declining patients’ quality of life.
Peripheral Arterial Disease
Narrowed or blocked peripheral blood vessels in the four limbs causes ischemic condition in muscle and skin tissues, with the following symptoms: a feeling of paralysis, coldness, intermittent claudication, ulcer of lower limbs (thrombic disease) or rest pain. It includes arteriosclerosis obliterans and Buerger’s disease.
Proof of Concept (POC)
A proof of concept (POC) is a demonstration to verify that a fundamental finding or concept has the real-world application. In development of drugs, POC refers to examination of a drug candidate compound for a certain disease in real patients after its effect was indicated in animal models.
Disclaimer: This is a translation of the news release posted in Japanese. In case of any deviations between the two language versions, the original document in Japanese shall take precedence.

AnGesMG,Inc.
Corporate Communications TEL:+81-3-5730-2480, FAX:+81-3-5730-2676 http://www.anges-mg.com Email:info@anges-mg.com

AnGes has the pharmaceutical company Vical as it’s representative for the United States.

“Collategene™
AnGes has applied Vical’s technologies to the local delivery of a gene that encodes an angiogenic growth factor that promotes the growth of blood vessels. AnGes announced that it had reached agreement with the FDA regarding a Special Protocol Assessment for a Phase 3 clinical trial of its angiogenesis product, Collategene™ (HGF plasmid), and that the FDA has granted “Fast Track” designation to Collategene™ as a treatment for critical limb ischemia (CLI), the severest form of PAD. AnGes is poised to start a global Phase 3 clinical trial of Collategene™ in patients with CLI. AnGes is also conducting a Phase 1/2 study for the treatment of primary lymphedema in Japan, for which the results are expected in the latter half of 2014.” .. Infomation from the Vical web site… http://www.vical.com/About-Us/overview/default.aspx

June 6, 2014 AnGes MG, Inc.
Grant Amount for “2013 Venture Aid Program to Promote Practical Application of Innovation” Confirmed by NEDO
Regarding CollategeneR (DNA Plasmid with HGF Gene) Lymphedema Project
AnGes MG, Inc. (“AnGes”) announced that the grant amount has been confirmed for the “2013 Venture Aid Program to Promote Practical Application of Innovation” by the New Energy and Industrial Technology Development Organization (NEDO). As announced by AnGes on May 15, 2014, the CollategeneR lymphedema project was selected for NEDO‘s program.
Project name: Grant amout: Period:
Clinical Development of Lymphedema Treatment Drug using HGF Plasmid
79,808,000 Yen
(Maximum amount equivalent to two-thirds of actual project costs) May 29, 2014 to February 28, 2015
Details of the program are as announced in the press release “CollategeneR (DNA Plasmid with HGF Gene) Lymphedema Project Selected for NEDO’s Venture Aid Program” on May 15, 2014.
The grant money is expected during the fiscal year ending December 2015, and this will have no effect on the business performance for the fiscal year 2014.
###
Disclaimer: This is a translation of the news release posted in Japanese. In case of any deviations between the two language versions, the original document in Japanese shall take precedence.

AnGesMG, Inc.
Corporate Communications TEL:+81-3-5730-2641, FAX:+81-3-5730-2635 http://www.anges-mg.com

More info… http://www.anges-mg.com/en/project/proj_develop.html
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Dr Corrine Becker with Lori

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Dr Corrine Becker with Lori March 2014 provided by Lori

This is a wonderful picture that Lori sent me today from her appointment with Dr Becker and Dr Vasilles in New York, earlier this month. When someone changes your life it is hard to find the words and a hug says it all!! Dr Becker was pleased with Lori’s progress and as time goes by her lower leg will improve more and more. At a later stage there may be a need for a small amount of liposuction to get rid of the fibrous, stubborn areas.

This is a Link to Lori’s story of Primary Lympedema and surgery

https://lymphnodetransplant.wordpress.com/2013/07/17/loris-story-of-primary-lymphedema-and-treatment/

Dr Corrine Becker is the pioneer of Lymph node Transfers and is responsible for teaching many doctors world-wide how to perform this surgery. In Paris she started more than 20 years ago and over the years has perfected the technique. That we have the opportunity to be part of this revolutionary treatment is truly giving hope to many. Over the next few years, with research into medications that help the development of the lymphatics, it feels like we are moving into exciting times.

This is a link to a study in Finland (2014) on Lymph node Transfers, it is long but there are items of interest about the use of Growth Factor written by Tiina Viitanen

http://www.doria.fi/bitstream/handle/10024/94237/AnnalesD1103Viitanen.pdf?sequence=2

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Copyright © 2013-2014 by Helensamia. All rights Reserved.

Feel free to share with others. It can be distributed via social media, reblogged or added to websites. Please do not change the original content and provide appropriate credit by including the author’s name and a link to this blog.
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Doctors visit… One year after Lymph Node Transfer

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centennial Park Sydney

The true meaning of life is to plant trees, under whose shade you do not expect to sit. ~Nelson Henderson

On Friday it was my one year check up with the surgeon who did my Lymph Node Transfer. In fact it was exactly to the day, March 14th 2014, and what a year this has been!! The doctor was happy with my progress, we established by the ultrasound that two functioning nodes are present, maybe three, improvements in the leg seem to be inline with what is expected at this stage. These changes are not easy to measure, as it is more about the condition of the leg by the end of the day. What I have noticed in the last few weeks is the ankle remains the same as in the morning. Prior to the LNT my ankle would have puffed up by the end of the day, even in my compression stocking, especially if I had to sit with the leg down and not elevated. Sitting at a conference, working at my desk, sitting at the table, talking to clients, standing to long, these and more would all have led to swelling. I can now do all of these things with out the ankle and foot getting all puffy! This is a huge plus as it means the nodes are starting to work. However although my L-Dex reading is now 7.1 the actual measurements are similar to the morning I was measured pre surgery. These measurements have been lost, but I had some old ones, so can compare those. My leg was never very big, as I would not have been a candidate for this type of surgery. Had my leg been larger or more fibrous I would then have needed liposuction, or a mix of LNT and liposuction, as some have had. Decisions on the type of surgery required and suitability can only be made by the specialist plastic surgeons and depend on the condition of the limb and how much fibrous tissue is present. Surgery for me was also to reduce/stop the incidence of infections.

I am part of a research program, at Macquarie University hospital in Sydney, and doctors have realised that measurements alone are not giving a clear picture of the improvements in the limb. They do not show that the limb has softened, they do not show the difference over the course of the day. There is however a new machine arriving that measures “moisture” in the limb, with this they hope to be able to do some more accurate, before and after comparisons. It also needs noting that the Lymphasytagraph that I had at six months, showed the injected dye moving up to the pelvis 20 minutes faster than pre surgery. Therefore results are a mixture of different things, L-Dex, Lymphasytagraph, ultrasound, MRI, measurements and mine and the doctors observations. Over the next year it will be interesting to monitor on going progress as the nodes continue to grow.

My doctor has suggested that I do two weeks of Complex Bandaging and Manual Lymph drainage, which will entail a trip to the hospital everyday to the physio department. He has requested this to move fluid out of the knee and middle of the leg, as this is much slower to reduce. He feels this would give the new nodes a “boost” and help them to work more efficiently, once some of the more stubborn fluid is removed. After the surgery my knee blew up like a football, so this has been the slowest area to respond. My next visit to the doctor will be in three months time to see how the Complex bandaging has helped.. Is the knee swelling during the day and are the nodes coping better? At this stage I am still wearing a compression stocking 30-40mmg. This may need to be reduced to a smaller size after the bandaging…

What should be remembered is that every patient is different when it come to treatment of their Lymphoedema. Some will be suited to surgery and some not. Plastic surgeons, who specialise in this type of surgery, will assess each individual, decided on suitability and if they fit the criteria, what surgery would be best. I write this blog from my personal experience and that of others, but in no way does it replace a specialists assessment. Below are some links to information on various types of surgery for Lymphoedema.

http://ecancer.org/journal/letter/9-is-there-a-role-for-surgery-in-the-management-of-lymphoedema.php

http://stanfordhospital.org/cardiovascularhealth/lymphaticvenous/treatments/surgery.html

http://corinnebeckermd.wordpress.com/about/

http://www.mdanderson.org/patient-and-cancer-information/cancer-information/cancer-topics/dealing-with-cancer-treatment/lymphedema/index.html

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