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Post by mnholdem on Apr 22, 2018 5:21:11 GMT -5
I noticed an interesting update on the pipeline graphic at the MannKind Corporate website. Notice how two pipeline candidates list "AVAILABLE FOR LICENSE" but the Treprostinil does not? This indicates to me that MannKind may have a collaborating partner for TreT.   |
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Post by boca1girl on Apr 22, 2018 6:19:44 GMT -5
I don’t believe that is a recent change. I remember seeing this chart before and that others had pointed out that Trep-T was not available for liicense.
It may very well be the case that a “licensee” is waiting in the wings pending a favorable outcome to Phase I trials. But Mike has also said that clinical trails should be relativly quick and inexpensive so maybe they are going it alone.
The chart shows Phase I complete March 2018 but May is just around the corner. Mike K just added a 3rd catyst that is public information. He must be talking about the Trep-T Phase I results.
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Post by pat on Apr 22, 2018 6:19:52 GMT -5
Who knows if that’s what the missing verbiage means.
But wouldn’t that change the conversation!
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Post by mnholdem on Apr 22, 2018 6:27:18 GMT -5
I don’t believe that is a recent change. I remember seeing this chart before and that others had pointed out that Trep-T was not available for liicense. It may very well be the case that a “licensee” is waiting in the wings pending a favorable outcome to Phase I trials. But Mike has also said that clinical trails should be relativly quick and inexpensive so maybe they are going it alone. The chart shows Phase I complete March 2018 but May is just around the corner. Mike K just added a 3rd catyst that is public information. He must be talking about the Trep-T Phase I results. MannKind issued a press release in early March that enrollment had just opened, so you may be misinterpreting the graph. investors.mannkindcorp.com/news-releases/news-release-details/mannkind-opens-enrollment-phase-1-trial-treprostinilThe ClinicalTrials.gov site displays start date of March 9, 2018 with Primary results expected Sept-2018 and trial completion in Dec-2018. Source: clinicaltrials.gov/ct2/show/NCT03464864?term=MannKind&cond=Pulmonary+Arterial+Hypertension&rank=1 |
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Post by golfeveryday on Apr 22, 2018 6:30:52 GMT -5
I don’t believe that is a recent change. I remember seeing this chart before and that others had pointed out that Trep-T was not available for liicense. It may very well be the case that a “licensee” is waiting in the wings pending a favorable outcome to Phase I trials. But Mike has also said that clinical trails should be relativly quick and inexpensive so maybe they are going it alone. The chart shows Phase I complete March 2018 but May is just around the corner. Mike K just added a 3rd catyst that is public information. He must be talking about the Trep-T Phase I results. MannKind issued a press release in early March that enrollment had just opened, so you may be misinterpreting the graph. investors.mannkindcorp.com/news-releases/news-release-details/mannkind-opens-enrollment-phase-1-trial-treprostinil study started in March. They are recruiting. Primary completion date is Sept 2018. |
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Post by boca1girl on Apr 22, 2018 6:31:40 GMT -5
Any idea when this Phase I trial is due to complete?
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Post by mnholdem on Apr 22, 2018 6:34:00 GMT -5
Any idea when this Phase I trial is due to complete? I updated my post (above) to include this info. Have a fine day!  |
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Post by digger on Apr 22, 2018 7:31:25 GMT -5
I don’t believe that is a recent change. I remember seeing this chart before and that others had pointed out that Trep-T was not available for liicense. It may very well be the case that a “licensee” is waiting in the wings pending a favorable outcome to Phase I trials. But Mike has also said that clinical trails should be relativly quick and inexpensive so maybe they are going it alone. The chart shows Phase I complete March 2018 but May is just around the corner. Mike K just added a 3rd catyst that is public information. He must be talking about the Trep-T Phase I results. I question whether the trials will be quick and inexpensive. The afrezza trials showed some people with COPD and smokers developed some sort of allergic like reaction that was serious enough to impose a black box. I suspect the FDA will require a lengthier trial than what Mannkind is anticipating to see if the same is necessary for tre-t. |
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Post by peppy on Apr 22, 2018 7:44:04 GMT -5
Treatment Pulmonary hypertension can't be cured, but doctors can help you manage your condition. Treatment may help improve your symptoms and slow the progress of pulmonary hypertension. Medications Blood vessel dilators (vasodilators). Vasodilators open narrowed blood vessels. One of the most commonly prescribed vasodilators for pulmonary hypertension is epoprostenol (Flolan, Veletri). The drawback to epoprostenol is that its effects last only a few minutes.This drug is continuously injected through an intravenous (IV) catheter via a small pump that you wear in a pack on your belt or shoulder. Potential side effects of epoprostenol include jaw pain, nausea, diarrhea and leg cramps, as well as pain and infection at the IV site.Another form of the drug, iloprost (Ventavis), can be inhaled six to nine times a day through a nebulizer, a machine that vaporizes your medication. Because it's inhaled, it goes directly to the lungs. Side effects associated with iloprost include chest pain — often accompanied by a headache and nausea — and breathlessness. Treprostinil (Tyvaso, Remodulin, Orenitram), another form of the drug, can be given four times a day. It can be inhaled, taken as oral medication or administered by injection. It can cause side effects such as a headache, nausea and diarrhea. Endothelin receptor antagonists. These medications reverse the effect of endothelin, a substance in the walls of blood vessels that causes them to narrow. These drugs may improve your energy level and symptoms. However, these drugs shouldn't be taken if you're pregnant. Also, these drugs can damage your liver and you may need monthly liver monitoring. These medications include bosentan (Tracleer), macitentan (Opsumit), and ambrisentan (Letairis). Sildenafil and tadalafil. Sildenafil (Revatio, Viagra) and tadalafil (Cialis, Adcirca) are sometimes used to treat pulmonary hypertension. These drugs work by opening the blood vessels in the lungs to allow blood to flow through more easily. Side effects can include an upset stomach, headache and vision problems. High-dose calcium channel blockers. These drugs help relax the muscles in the walls of your blood vessels. They include medications such as amlodipine (Norvasc), diltiazem (Cardizem, Tiazac, others) and nifedipine (Procardia, others). Although calcium channel blockers can be effective, only a small number of people with pulmonary hypertension respond to them. Soluble guanylate cyclase (SGC) stimulator. Soluble guanylate cyclase (SGC) stimulators (Adempas) interact with nitric oxide and help relax the pulmonary arteries and lower the pressure within the arteries. These medications should not be taken if you're pregnant. They can sometimes cause dizziness or nausea. Anticoagulants. Your doctor is likely to prescribe the anticoagulant warfarin (Coumadin, Jantoven) to help prevent the formation of blood clots within the small pulmonary arteries. Because anticoagulants prevent normal blood coagulation, they increase your risk of bleeding complications. Take warfarin exactly as prescribed, because warfarin can cause severe side effects if taken incorrectly. If you're taking warfarin, your doctor will ask you to have periodic blood tests to check how well the drug is working. Many other drugs, herbal supplements and foods can interact with warfarin, so be sure your doctor knows all of the medications you're taking. Digoxin. Digoxin (Lanoxin) can help the heart beat stronger and pump more blood. It can help control the heart rate if you experience arrhythmias. Diuretics. Commonly known as water pills, these medications help eliminate excess fluid from your body. This reduces the amount of work your heart has to do. They may also be used to limit fluid buildup in your lungs. Oxygen. Your doctor might suggest that you sometimes breathe pure oxygen, a treatment known as oxygen therapy, to help treat pulmonary hypertension, especially if you live at a high altitude or have sleep apnea. Some people who have pulmonary hypertension eventually require continuous oxygen therapy. www.mayoclinic.org/diseases-conditions/pulmonary-hypertension/diagnosis-treatment/drc-20350702 |
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Post by mnholdem on Apr 22, 2018 10:25:19 GMT -5
I don’t believe that is a recent change. I remember seeing this chart before and that others had pointed out that Trep-T was not available for liicense. It may very well be the case that a “licensee” is waiting in the wings pending a favorable outcome to Phase I trials. But Mike has also said that clinical trails should be relativly quick and inexpensive so maybe they are going it alone. The chart shows Phase I complete March 2018 but May is just around the corner. Mike K just added a 3rd catyst that is public information. He must be talking about the Trep-T Phase I results. I question whether the trials will be quick and inexpensive. The afrezza trials showed some people with COPD and smokers developed some sort of allergic like reaction that was serious enough to impose a black box. I suspect the FDA will require a lengthier trial than what Mannkind is anticipating to see if the same is necessary for tre-t. You're referring to bronchospasm, which is not an allergic reaction and, unlike Afrezza, TreT is a treatment specifically FOR the lungs - pulmonary arterial hypertension (PAH). There are already inhaled medications on the market for this condition. The trial protocols have already been worked out between MannKind and FDA, so the duration and costs for this trial have already been established, well before the CEO's comments about it being relatively inexpensive. |
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Post by digger on Apr 22, 2018 23:03:19 GMT -5
I question whether the trials will be quick and inexpensive. The afrezza trials showed some people with COPD and smokers developed some sort of allergic like reaction that was serious enough to impose a black box. I suspect the FDA will require a lengthier trial than what Mannkind is anticipating to see if the same is necessary for tre-t. You're referring to bronchospasm, which is not an allergic reaction and, unlike Afrezza, TreT is a treatment specifically FOR the lungs - pulmonary arterial hypertension (PAH). There are already inhaled medications on the market for this condition. The trial protocols have already been worked out between MannKind and FDA, so the duration and costs for this trial have already been established, well before the CEO's comments about it being relatively inexpensive. No matter, according the trial requirements, they already exclude lung problems -- "History of chronic lung disease such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung disease, pulmonary fibrosis, etc." -- as well as potential lung problems -- "Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio < 80% predicted or FEV25-75 <50% predicted" -- as well as smokers -- "Smoking or use of tobacco- or nicotine-containing products within 6 months prior to the first dose of study medication until the end-of-study visit." Some curious requirements that I only just noticed -- "Has been on a significantly abnormal diet (as determined by the Investigator) during the 4 weeks preceding the first dose of study medication." "Consumption of beverages or foods that contain alcohol, grapefruit, poppy seeds, broccoli, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours prior to the first dose of study medication until the end-of-study visit. Subjects will be instructed not to consume any of the above products; however, allowance for an isolated single incidental consumption may be evaluated and approved by the study Investigator based on the potential for interaction with the study drug." "Unwilling to remove any artificial nails (e.g. acrylic, gel) or fingernail polish and to not use such products for the duration of the study." If the drug were approved, would those restrictions be on the label as well? Tyvaso trials -- eg clinicaltrials.gov/ct2/show/NCT00147199 -- didn't include similar restrictions about COPD, FEV, smoking and the rest. |
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Post by mnholdem on Apr 23, 2018 2:45:40 GMT -5
Your link is to the Tyvaso Phase 3 trial. By then, safety considerations had already been determined and were eventually written into the label. IMPORTANT SAFETY INFORMATION FOR TYVASO
Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System.
Before you take Tyvaso, tell your healthcare provider about all of your medical conditions, including if you:
Have a lung disease (such as asthma or chronic obstructive pulmonary disease (COPD)).
Have a lung infection.
Have liver or kidney problems, as your ability to tolerate Tyvaso may be affected.
Have low blood pressure, as Tyvaso may cause symptomatic hypotension (low blood pressure).
Are pregnant or plan to become pregnant. It is not known if Tyvaso will harm your unborn baby. Women who can become pregnant should use effective birth control while taking Tyvaso.
Are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk.
Source: www.tyvaso.com/dtc/isiMannKind is only at Phase 1. |
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Post by liane on Apr 23, 2018 4:34:44 GMT -5
"Unwilling to remove any artificial nails (e.g. acrylic, gel) or fingernail polish and to not use such products for the duration of the study." If the drug were approved, would those restrictions be on the label as well? Tyvaso trials -- eg clinicaltrials.gov/ct2/show/NCT00147199 -- didn't include similar restrictions about COPD, FEV, smoking and the rest. Probably using some sort of pulse oximetry (sensor placed over the nail bed) to check oxygen levels. This would only be for the study |
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Post by mnholdem on Apr 23, 2018 8:55:38 GMT -5
There are numerous publications related to recommended diet for people with pulmonary arterial hypertension. Many of the food items listed for exclusion during the trial period are actually BENEFICIAL and recommended, so I suspect that MannKind's decision to eliminate certain food items during the trial period is to minimize certain food interactions in order to better evaluate the drug's safety and effectiveness. |
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Post by slugworth008 on Apr 23, 2018 9:10:45 GMT -5
Of course they have a partner. That's why they haven't announced anything.  |
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