Drug for lymphedema treatment

[Alla]

Hello everybody!

Do you know that the first drug for lymhedema treatment is semble to be found? Please, read about this study published May 10 in "Science Translational Medicine":

med.stanford.edu/news/all-n...

[CCT67]

This is a fantastic development and all of us Lymphies are hopeful about the outcomes - we must be patient to see if Ubenimex/ULTRA can help human lymphatics as effectively as it does in mice.

The human clinical trials are just starting in respect of this potential drug treatment. The lead researcher is Dr Stanley Rockson at Stanford University Medical Centre in California, with two other US sites (Ohio and Florida) and 1 site in Australia. Anyone reading this who lives in the US or Australia and want to become involved in the trial the 3 sites are still 'recruiting' viable participants.

We won't know for a couple of years whether ULTRA will be a successful drug treatment to reverse the effects of LE. Fingers and toes crossed and lots of prayers that this is the cure millions of Lymphies have been waiting for!!

[Alla in reply to CCT67]

As we can read from the article, the first phase of clinical trial WITH HUMANS are already finished, now it is going to start the second one. And the Eiger BioPharmaceuticals has licensed intellectual property developed by Dr. Rockson and his team. Look at the site of the Eiger Bio: eigerbio.com/lymphedema/pha...

The site of the scientific article about the study:

eigerbio.com/resources/Tian...

[CCT67 in reply to Alla]

Indeed... it's a multi phased trial with the second phase starting meaning they've widened the net of who can seek to participate based on broader threshold criteria. As for the results we shall see but I do hope Ultra will be the answer for both primary and secondary LE

[lovesradio]

This is a really exciting development, especially for all the posters on this site who are having real struggles getting proper support and the high cost of current treatment options. I know I am very, very fortunate to be in the position I am regarding self management with good physio support in the background and a local pharmacy who now mostly order the correct Medi armsleeves!

[lymphite]

I did know about this. They are on their second prospective trial. I live in California and wanted to join but they are only accepting people with leg lymphedema. The results from the first grisly was good.

[divadogface in reply to lymphite]

I have in both legs really would love to join trial I live in Ak but can get to ca. anytime let me know how to join this trial thanks

[Alla in reply to divadogface]

Hello divadogface,

You can find the information about the trial of Ubenimex, locations and the contacts here:

clinicaltrials.gov/ct2/show...

[ulverin]

Does anyone have information of when this would be available for patients? I heard it takes approximately 5 years that a drug is on market, but I assume this can vary tremendously. A second trial going on it sounds not so very far...

[Alla in reply to ulverin]

I have no ideia. Maybe 5 years, but since when? Since the beginning of the trials? As for as I know, they have started this trail some years ago, at least in 2013. Another thing, this drug -ubenimex - is already on market in Japan, but it is't yet being used for lymphedema treatment.

[CCT67 in reply to ulverin]

It will be a few years at least after the trials conclude and research published. The trials are only part way through. Then the FDA in America has to approve. Then it will have to be approved for the UK market, and the NHS will go through its process for approving it on prescription. We could be in store for a long wait but hopefully not!!

[lymphite in reply to ulverin]

Sorry but there is a video on you tube from the reasearchers and they said if the trial is good they apply for a formal training and will need to do more than one of those so at least 8 years before FDA approval. The drug is in use in Japan for 20 years for reducing blood vessel inflammation from chemotherapy. FDA is supper cautious. Maybe docs in Europe would prescribe it off label and see if it works.

[lymphite in reply to lymphite]

The drug is Ubinemix.

[syrup01]

I don't want to burst any bubbles but reading this analysis does explain a lot

torontophysiotherapy.ca/ube...

Basically states it's great when treating an initial injury to lymphatics but nothing to suggest it will help people with long standing conditions.

However I will try anything and if they trial in the UK, I'm in!!!!

[lymphite in reply to syrup01]

I think you need to watch the video that is linked in this assessment. I believe he is completely wrong. The description of how the drug works by the researcher, Dr. Rockson, Is very detailed on it affections the disease in the skin. The first prospective trial was placeboed and had 124 participants with lymphedema from 6mons to 6 years duration. He says they were able to show that it is effective because of the changes in the patients on the drug that didn't occur in the placebo group. He also shows slides from a biopsy and skin thickness measurements on the arm of a patient. This is at about 14- 16 min into the video.

[skybluepink in reply to lymphite]

I think placebo groups are unethical out of order & research should be patient orientated asking why not using discriminatory criteria.

[sammyvan]

When they have trials like this, where the results are good and everything is moving in the right direction, I do wish that this infernal ''trial period'' could be waived in certain cases?

What if a group of people said they would be willing to start the drug/drugs right now, and to hell with the consequences!! I know that my life is really dominated by this disease, that every day starts with searching for new blisters/infection, that I get almost NO help from the medical fraternity [ apart from one dedicated nurse! ] and feel completely alone. If not for this forum, I would have no where to go for help.

So why can't I volunteer to take the treatment? If it works then millions more would benefit. If not, or if something goes wrong....then I really would not care much anyway. Sounds defeatist, but that is the way I feel. I would do anything to be able to walk again, to get out of these four walls, to not live in fear and pain.

Sorry - must be a bad day! I normally have some fight left in me. I so admire all of you who take time to help others.

[Alla in reply to sammyvan]

Yes. Certainly, every drug works better, if it is being used as soon as possible, at the beginning of the inflammatory process. But, in reality, acute lymphedema ( acute lymphatic injury) doesn t exist. Because it turns immediately cronic. It the LE stars, it is irreversible, even so it is very small. Besides, only the patients , whose diagnose of LE was confirmed by the lymphoscintilographie were able to participate at the first phase of trials (with humans). But this exam only shows LE in serious cases, and that means that all the patients have serious lyphatic injuries. Eves so, the results of the trials are good.

[CCT67]

Hi Alla

I'm a member of LE&RN who sponsored this webinar by Drs Rockson and Quan not long ago about the Ubenimex trials currently in phase 2. Thought you may find it interesting - it's now available on Utube - Clinical Trials for Lymphedema: what you need to know

youtu.be/KlBTvKU5bso(Not working as expected?)

[Alla in reply to CCT67]

Thank you, CCT7! Very interesting.

[skybluepink in reply to CCT67]

Could this help Primary Lipo- Lymphoedema/ Obesity Stage 2 .I am in uk with no access or provision even Privately because of BMI & heart failure that suspect is related even though self funded own gastric band & abdomnoplasty in Belgium to halt progression !

[CCT67 in reply to skybluepink]

The drug trial has been discontinued as from this week after phase 1 and 2 of the clinical randomised trial did not have the favourable results that were hoped for. Some people did benefit from Ubenimex but others did not. The drug trialled, Ubenimex iis not currently available in the UK but will hopefully be liscenced soon so that we can try it, if we want to.

Have you applied for personal independence payment/PIP benefit (previously DLA)? It could be used to pay for regular manual Lymphatic drainage which would likely be extremely helpful in treating your Lipo-Lymphoedema. There are qualified MLD therapists on MLDUK website; search by post code. Also having a very healthy, clean diet without ready meals and low in salt is helpful for symptom management

[skybluepink in reply to CCT67]

I all goes in using WAVs mobility scooters & employing others to assist as Function gone .I also self fund oxygen acupuncture , refexology , Private Drs . It shouldn't have to be used for basic assistance .

[thehealthylady in reply to CCT67]

As I read this, the trial being halted, was referring to the Pulmonary Arterial Hypertension (PAH) in the Phase 2 Liberty Study that was using the drug Ubenimex. pulmonaryhypertensionnews.c....

[CCT67 in reply to thehealthylady]

The trial I posted about re Ubenimex was not pulmonary related , it was the ULTRA Ubenimex clinical phase 1&2 trials of Primary lower limb Lymphoedema.

Eiger BioPharmaceuticals terminated further phases; this was announced in their press release last week (18th or 19th Oct).

The lead investigator of the trial, Dr Rockson spoke about it publicly yesterday. He still feels Ubenimex may offer great hope for some Lymphies and he is continuing to study it at Stanford University , but the international ULTRA Ubenimex trial has been permanently discontinued

[thehealthylady in reply to CCT67]

Yes, you are right. It took some looking , but I do see that the Ubenimex Trial was halted. Thanks for the update.

[morganite]

lets hope all this comes to fuition for us