禾伸堂生技「雙喜臨門」製程技術、臨床進度大跨步 鉅亨網作者： 鉅亨網記者張旭宏 台北 | 鉅亨網 – 2014年2月21日 上午10:55 興櫃新藥股禾伸堂生技(禾生技)(4194-TW)開春利多不斷！日前新竹廠通過先導工廠GMP評鑑，有助於製劑技術加速發展，另外申請經濟部業界開發產業技術計劃「發炎性腸道疾病新複方IBD98-M新藥開發計劃」已經審查通過且獲得補助款，雙喜臨門，在製程技術及臨床用藥的進度提供務實且正面的助益。 禾生技在台灣竹北生醫園區依PIC/s GMP規範建立自主的先導工廠，已經過台灣衛生署查廠，在元宵節當天通過先導工廠 GMP 評鑑，規劃於未來申請美國FDA查廠審查，以取得美國FDA c-GMP廠資格，先導工廠除了開發「IBD98-M」新劑型所需的製程技術，以供給PhaseⅠ-Ⅲ期的臨床用藥外，同時肩負開發未來其它新藥所需的製程技術。另外，禾生技以透明質酸作為傳輸載體所發展的藥物傳輸平台，經過研發團隊投入超過五年的時間，已開發出新複方新藥「IBD98-M」，用於治療炎性腸道疾病，日前申請經濟部業界開發產業技術計畫「發炎性腸道疾病新複方IBD98-M新藥開發計劃」，全程開發期程20個月，計劃總經費4100萬元，獲得經濟部技術處補助金額新台幣1,230萬元，預計在103年間以505(b)(2)的途徑申請新藥IBD98-M在美國FDA臨床試驗審查(IND)，補助款對於計劃中各項實驗的推展帶來正面的挹注。 禾生技的新藥「IBD98-M」，係將藥物活性分子 5-aminosalicylic acid (5-ASA)引導至結腸、迴腸末端之病灶處後，再緩慢釋出，與Lialda具緩釋及控釋特性相同；加上以透明質酸為藥物載體，對人體無顯著副作用，且具有良好生物相容性以及加速傷口癒合的特性，預計今年首季申請美國IND PhaseⅠ，103年底完成PhaseⅡa之臨床試驗，加上今年及明年亦有多項以透明質酸應用於腸道疾病的新醫材上巿，除增添營運動能外，展現其「透明質酸藥物傳輸技術平台」的發展潛力。
Treatment options in detail (Inflammatory Bowel Disease, IBD)
Aminosalicylates Aminosalicylates are the first treatment option for mild to moderate ulcerative colitis. They help reduce inflammation and can be taken:•Orally: as a tablet or capsule that you swallow•Suppository: a capsule that you insert into your rectum, where it then dissolves•Enema: where fluid is instilled into your colon How you take aminosalicylates will depend on the severity and extent of your condition.The side effects of aminosalicylates can include: Diarrhoea•Feeling sick•Headaches•Skin rashes
Corticosteroids Corticosteroids (steroid medication) may be used if your ulcerative colitis is more severe or not responding to aminosalicylates. Steroids act much like aminosalicylates. That is, they help by reducing inflammation, except they are a lot stronger. As with aminosalicylates, steroids can be administered orally, topically or as a suppository or enema. Long-term use of steroids, especially oral steroids, is not recommended as they can cause potentially serious side effects. Therefore, once your colitis responds to treatment, it is likely you will need to stop using them. The side effects of short-term steroid use can include: Changes in the skin (e.g. acne)/Sleep and mood disturbance/Indigestion/Swelling/Side effects of prolonged steroid use (more than 12 weeks) include: Osteoporosis – weakening of the bones /High blood pressure (hypertension)/Diabetes – or worsening of existing diabetes/Weight gain/Cataracts – where cloudy patches in the lens of the eye can make vision blurred or misty
To minimise the risk of prolonged steroid use, it is important that you: Eat a healthy and balanced diet with plenty of calcium/Maintain a healthy body weight/Stop smoking/Do not drink more than the safe limits of alcohol (recommended daily levels are three-to-four units of alcohol for men and two-to-three units for women)/Exercise regularly You will also require regular appointments to check for high blood pressure, diabetes and osteoporosis if your treatment requires long-term use of corticosteroids.
Immunosuppressants You may be given immunosuppressants if your condition is still not responding to treatment, sometimes in combination with other medicines although it may also be recommended to withdraw your steroid treatment to reduce possible side effects. This is known as steroid-sparing therapy. Immunosuppressants work by reducing or suppressing your body's immune system. This will then stop the inflammation caused by ulcerative colitis but they may take a while to start working (typically two to three months). The drawback is they affect your whole body, not just your colon. This may make you more prone to infection, so it is important to report any signs of infection, such as inflammation, fever or sickness, promptly to your GP. They can also lower the production of red blood cells, making you prone to anaemia. You will need regular blood tests to monitor your levels of blood cells and check for any other problems. The preferred immunosuppressant used in the treatment of ulcerative colitis is a medicine known as azathioprine. This is because it rarely causes side effects in most people. However, long-term use of azathioprine has been linked to a small increase in the risk of cancer, particularly skin cancer. Azathioprine is not normally recommended for pregnant women. Unfortunately, if it is the only treatment that successfully controls your condition, it is likely you will be advised to continue taking it. Any risk to you or your child is far outweighed by the risks presented by ulcerative colitis.
Anti TNF-α This type of medication is only used to treat severe active ulcerative colitis if you are unable to take steroid medication for medical reasons, such as being allergic to it. There is also a relatively new type of medication called infliximab that can be used to treat severe ulcerative colitis where corticosteroids cannot be used for medical reasons. It works by targeting a protein called TNF-alpha which the immune system uses to stimulate inflammation. This is given through a drip in your arm over the course of two hours (infusion administration). Further infusions are given after two weeks and again after six weeks. Infusions are then given every eight weeks, if treatment is still required.
Around one-in-four people have an allergic reaction to infliximab and experience symptoms such as: Joint and muscle pain/Itchy skin/High temperature/Rash/Swelling of the hands or lips/Problems swallowing/Headaches
Symptoms range from mild to severe and usually develop in the first two hours after the infusion has finished. Rarely, people have experienced a delayed allergic reaction days or even weeks after an infusion. If you begin to experience the symptoms listed above after having infliximab, seek immediate medical assistance. You will be carefully monitored after your first infusion and, if necessary, powerful anti-allergy medication, such as epinephrine, may be used.
Other complications that might occur and have been reported are: "Reactivation" of a previously dormant tuberculosis (TB) infection - therefore, it may not be suitable if you have a previous history of TB; The same is also true with the viral infection hepatitis B; Infliximab is also not recommended for people with a history of heart disease. Infliximab will make you more vulnerable to infection, so avoid contact with people who have a known chickenpox or shingles infection. It's important to report any symptoms of a possible infection, such as coughs, high temperature or sore throat, to your GP.
Surgery Surgery is the most extreme course of treatment and may be recommended when all medications have failed or if "flare-ups" of symptoms are frequent. This involves the removal of a section of the colon. If you are not (or no longer) responding to intensive medical treatment, then surgery may be required. You may also wish to consider surgery if your maintenance therapy is not working and the condition is affecting your quality of life. Surgery involves permanently removing the colon– a colectomy. As part of the operation, your small intestine will be re-routed from the colon so it can pass waste products out of your body. This used to be achieved by carrying out an ileostomy, where an incision is made in your stomach and the small intestine is pulled slightly out of the hole and connected to a pouch (which collects waste materials). However, in recent years, another technique known as the ileo-anal pouch has been increasingly used. This is an internal pouch constructed by the surgeon out of the small intestines and then connected to the muscles surrounding your anus. The pouch can be emptied in much the same way when you pass stools. The advantage of this technique is that you are not required to carry an external pouch.