XIAFLEX Phase II Trial In Human Lipoma

Until now, there is no approved, non-surgical treatment for lipoma. Nonetheless, it seems that a biopharmaceutical company plans to design a specific treatment to help people with lipoma. It’s named BioSpecifics Technologies Corp. (NASDAQ: BSTC) and developed collagenase-based products.


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These products are marketed as XIAFLEX in the U.S. and XIAPEX® in Europe and Eurasia. The company announced that it has started its Phase II trial of XIAFLEX (collagenase clostridium histolyticum), a treatment for human lipoma.

Phase II trial is perfect for patients who suffer from lipomas as there is no FDA-approved pharmaceutical for this type of condition. Thomas Wegman, President of Biospecifics said: “We are enthusiastic about the promising clinical results already seen with injectable collagenase in this indication, as well as in canine lipoma for which we also have an ongoing Phase II trial. We look forward to completing both of these studies next year.”


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The study involves a single injection, open label trial and will enroll 14 patients. The treatment is administered in four ascending doses, ranging from 0.058 mg to 0.44 mg of XIAFLEX.

Efficacy endpoints will include:

  • the primary efficacy endpoint will consist of a change in the visible area of the lipoma at about 6 months post injection
  • the secondary efficacy endpoints refer to a change in length of the lipoma

The study will also include pieces of information of lipoma features and will administer a questionnaire to each patient prior to injection. Additionally, safety information will also be a part of this research.


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This study could lead to a wonderful solution to a non-surgical treatment for lipomas of all sizes. The injectable collagenase for lipomas has a great potential, an idea supported also by Zachary Gerut, M.D., lead investigator on the trial.

Auxilium Pharmaceuticals, Inc. (Auxilium), the strategic partner of Biospecifics can opt for license development and marketing rights to this indication. This would mean an opt-in payment and also potential future milestone and royalty payments from Auxilium to Biospecifics.

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Learn More About The Excision Before You Do It

Having to remove a lipoma is not the end of the world. This is an adipose tumor that often appears in the subcutaneous tissue on several areas of the body. It mostly appears on those who between 40 and 60 years old, but this is not a rule, it can also appear on younger or older people. Lipomas grow slowly and in many cases they can be left as they are. They look similar to liposarcoma, but only a doctor can establish if the growth the patient has under his skin is a lipoma or a liposarcoma.

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If you are the one who has a lipoma and you plan to get rid of it, this is the perfect place to read more about this health issue and about the surgery that can help you fix the problem. As mentioned earlier, a lipoma can be left as it is, but if it bothers you, if it affects your looks or if you simply want to take it out you can do it with the help of a pretty simple operation. A problem that might affect you is the financial one, as in most of the cases, if a lipoma is not dangerous, the surgery is considered to have cosmetics purposes and is not paid by the insurance company.

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The lipoma you have can be an usual one, soft, with a doughy feel and with the skin over it looking normal. It may also be an infiltrating lipoma, if it infiltrated into the muscle. If it is not malignant and it doesn’t present any problems, the lipoma you have can be removed quite easily through an excision. The excision is made on the skin which covers it. The incisions that the doctor will make follow the skin tension lines and are much smaller than the tumor, to avoid a big and unpleasant-looking scar. The piece of skin which covers the lipoma is held with an Allis clamp to ensure the dissection. This is done under the subcutaneous fat. When the tissue is cut, the doctor must pay a lot of attention to avoid cutting nerves or blood vessels that lie under the tumor. When a part of the lipoma is dissected from the tissue around it, the doctor will hold it with clams to remove it totally, as a whole. The tissue remaining is then palpated, so the doctor can make sure the tumor was completely removed and the possibility of complications is reduced.


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After the lipoma is completely removed, suture is performed. The space is closed and Vicryl sutures are used. In some cases, the place needs to be drained to avoid the accumulation of fluids. To avoid the appearance of a hematoma, a pressure dressing is used on the spot where the tumor was. You will receive care instructions to make sure your would will not suffer an infection. In the beginning you will need to do a check once in a few days (about two times a week). After a few weeks the sutures are removed. The scar will be more visible in the beginning, but it will vanish in time. The tumor will be analyzed just to make sure everything is OK and you don’t need further investigation or treatment.

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As you can see, the surgery which will help you get rid of the lipoma is not that difficult. You should not be afraid because your doctor will explain every step to you and you will be able to find out all the details about how it went immediately after it is over. Your recovery will probably be very fast and you will be fine, as such a tumor is not a really big problem.

Removing A Lipoma

A lipoma is a tumor formed from adipose tissue. This is not dangerous, but this does not mean it should not be seen by a doctor. It should be soft and easy to move. Also very important, it should not hurt. Most of the lipomas are small, having less than one centimeter, and they do not grow. However, there are cases in which they grow and if this happens, a new visit to the doctor is recommended. Lipomas can appear anywhere on the body and they generally grow in people who reached adulthood, actually, the majority of them are between 40 and 60. The cause of their appearance is not analyzed, but it is generally known that they might appear after minor injuries or they can be hereditary. A treatment for them is not mandatory and in many cases, they are not even removed, but if they grow and they bother the patient or if the patient has a problem with them because his looks are affected, the lipomas are removed with surgery.

Many times, looks are the only reason for which lipomas are removed, as they are not dangerous and do not represent a problem for the health of the patient. There are small chances for such a bump to transform into cancer, but a doctor needs to see the patient from time to time. If the removal is necessary, the patient needs to pay it, as the procedure is considered a cosmetic one. Only if the bump affects the mental or physical state of the patient it can be supported by the health insurances. In some cases, lipomas press nerves and cause pain and they must be immediately removed. Usually, they can be removed in private clinics with the use of local anesthesia.

If the lipoma has grown and is too big, the procedure may need general anesthesia. This will numb the area where it is located and the doctor will be able to cut the skin in order to remove it. The wound can be easily closed with stitches and the patient can leave the hospital after just a day. If the fat is not completely extracted, the pump may reappear, this is why another procedure, that of liposuction is not recommended in these cases. The best thing about lipomas is that they do not endanger health and they can be easily removed.

Details On The Treatment Of Lipoma

If you have been diagnosed with lipoma, there is nothing you should worry about. Obviously, this is not such a wonderful news, but this tumor does not represent a real danger for your health. It is a benign tumor and is made of soft adipose tissue. It can probably be moved, it does not hurt when you touch it and it does not really disturb you. Even so, you should get it out of your body, because it is not something natural. Many adults have lipomas, but also some children. The causes for which the lipomas appear are many times hereditary. Sometimes, this tumors appear after traumas, as effect of minor injuries. No matter why do you have one, the important fact is that you should get it out and in order to do this, you need a treatment.

If the tumor is very tiny, many times it is left like that, but if it continues to grow, it needs to be removed. If you are verifying details about the treatment of lipomas, it is clear that you want it out. Doctors usually recommend the removal of lipomas if they affect the movement. Even so, most people decide to remove these tumors in order to regain their looks. Your look is equally important and you should feel good about yourself, so take it out as soon as you can. If your tumor will continue to grow, you may become suspect of liposarcoma. In such a case, after it will be taken out, it will be verified to see if everything is alright. In any case, a bump like this on your body cannot be considered 100% safe only after it is removed and verified.

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Usually, the lipomas are removed with a simple excision. If they are not very big, the anesthesia is just local and the surgery does not take more than 30 minutes. In most of the cases, the patient is cured after surgery, but you should be aware that there also are cases in which the lipoma reappears after some time. Of course, there are just 2% chances for this to happen. The tumor can also be removed by liposuction and the best thing about this procedure is that it leaves less scars. If you have a big tumor, it may not be removed completely like this, thus reappear soon after intervention.

>>>>>Click here to Download our eBook today and learn how to treat Lipoma Naturally<<<<<