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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14 thoughts on “Research from Japan brings hope……. Medication to treat Lymphedema!

    • The original patent for this drug was for vascular “repair” and they are now looking at the lymphatics.. The studies so far have been in Japan and I think a well guarded secret by virtue of the competition between drug companies.. I think there are trials in the USA for vascular use but not Lymphatic as yet… Every country wants its own trial to allow its use… As always we await results !!! There could be results on line for vascular use…

  1. Wow! As always your blog gives me a huge lift and fills me full of hope! Will need to study this one a bit more as it is quite technical ( and I am not!) but understand enough to know this is brilliant. Thank you! Xx

    • I to find it hard to understand… But I am assured by those that know there is great hope in this area… That money is being spent on research for LE is a huge plus😃😃😃

  2. I hope this can be it ! Fingers crossed. On their US partners website Vical it says that they expect already to have the results from the first trial in the end of 2014, which is very soon! Hopefully it will be positive !

  3. Hey Helen, looks like there is an update on the Anges website… very clear in how HGF works… They found out already in 2006 that it can create new lymphatic vessels … that is 8 years ago! It looks like they are quite confident in having it as a novel treatment. Oooooh I hope so! Thanks that researcher now that although there is treatment, it is not enough. They say : ‘However , this treatment is symptomatic.’ Well said😉
    http://www.anges-mg.com/en/project/proj_develop.html

    • I’m not sure what exactely you wanted to say (sorry If I might have missunderstood you). I think Anges wants to say, that the current ways of treating lymphedema are not curative, but rather symptomatic and need to be conducted throughout life. But all of this could change with Collategene.
      Quote: “There is no fundamental treatment available for lymphedema and the existing treatment is mainly focused on supportive care such as massaging and applying compression garments. However, this treatment is symptomatic, and it is necessary for it to be continued throughout the patient’s life.”

      Only after that they start talking about their own medication, which seems to be curative. And that would mean – an end to our suffering.

      But even If not -. I would rather take regulary injections for the rest of my life and get rid of garments, skin issues and time consuming lymphatic drainages. I mean seriously.

  4. Hi there, I’m also a lymphedema patient, but from Germany. In my search for new treatments I stumbled upon your site. This is a very hopeful account on a promising treatment for lymphedema. Especially losing the compression garments would be heaven for me. Living without them in summer…I can’t even start to tell you how much I would appreciate that. And I’m pretty sure our summers are soft and mild compared to yours.
    For the “money aspect” I have to say – many doctors over here don’t even want to talk about new medications, because they earn immense amounts of money with their rehabilitation clinics, bandages, lymphatic drainages etc. etc.
    There’s always money in any kind of patient and treatment, If you know what I mean, but not every treament unburdens us in the same way.

    I think this is one big step to a great breakthrough!🙂

    Cheers from far, far away!

    Sophie

    • Yes i try to gather together new information on the treatment of Lymphedema… As you say and as we all know we need more… Not just keeping it controlled but to have to cured… My dream is to throw away my compression garments. To not have to think about the 24/7 care… This research could bring that to fruition … We can inly hope 😃 also love to connect with others across the world.. Only others with Lymphedema understand what it is like to live with and can support each other. Helen

      • Heyy Sophie…

        I was trying to say the same like you🙂..
        That current treatment is symptomatic and the Collategene might be a cure…
        I said ‘ Well said ‘ to the company because they finally confirm that current is only symptomatic.

        This has always been a kind of frustration…that doctors somehow think you Only need to wear garment, Only need to go yo mld, Only …. This is so time -and like you said – money ! consuming, but they pull it away like an ‘effective treatment’.
        And then it is not even effective! Sometimes, no matter what you do it goes better, or worse… because it is more hot, cloudy or just without a reason:/.
        I really start to think about this money aspect of this treatment…people are so dependend on their treatment.
        Let’s all hope for a real and safe treatment, and fast🙂🙂 If there is one thing you need to have with le is patience…and i don’t!

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