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Insmed Incorporated Message Board

rehdvm2004 105 posts  |  Last Activity: Apr 16, 2014 9:20 AM Member since: Oct 21, 2004
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  • rehdvm2004 rehdvm2004 Apr 16, 2014 9:20 AM Flag

    Cipro is safer than amikacin. Floroquinolone versus aminoglycoside.

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Apr 16, 2014 9:19 AM Flag

    Particularly in view of the outcome of the clinical trial for Arikace over at INSM. This group will pave the way for ARDM.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    officially confused

    by walktheline43 Apr 15, 2014 1:10 PM
    rehdvm2004 rehdvm2004 Apr 16, 2014 8:00 AM Flag

    This is all "stock presentation and positioning" stuff. It has nothing to do with the science which "slowly" drives the entire operation to success. If you want to play the market while the science slowly pushes through the regulatory pathway to approval . . . be my guest. If you want to buy and hold for scientific and regulatory milestones . . . you have to wait years. That is how long it takes to demonstrate "safety and efficacy" in treating specific human conditions such as NTM infections. But fortunately, INSM is showing the way and making the mistakes for ARDM.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    career positions numbers down

    by iounothjing1 Apr 15, 2014 4:44 PM
    rehdvm2004 rehdvm2004 Apr 16, 2014 7:42 AM Flag

    They are hiring because of the complexity of the roll out and NDA application processes. Besides, if INSMs next clinical trial protocol is for "first time" NTM or CF/Pa patients, the results will be vastly improved. This is why these treatments are "evolutionary" and few are "revolutionary." Most of the "breakthrough applications at the FDA came out of CBER (biologics) and only two were approved. Arikace will be by the longer process, but in a timely fashion. INSM has only been working on Arikace for 3 years and one year was wasted under the "witless" merger team. Gone but not forgotten!

    GLTASL

    Sentiment: Buy

  • Reply to

    officially confused

    by walktheline43 Apr 15, 2014 1:10 PM
    rehdvm2004 rehdvm2004 Apr 15, 2014 8:19 PM Flag

    The most important aspect of Pulmoquin inhalational antibiotic therapy is the high level of antibiotic that reaches the alveoli, conducting airways, fixed macrophages and primary bronchi with just once per day inhalation therapy. INSM proved this is a head to head comparative study with TOBI (tobramycin inhalation solution) in Europe with CF patients infected with Pseudomonas aeruginosa. Once per day antibiotic liposomes has the corner on the inhalation antibiotic therapy market for the foreseeable future. What form of therapy is less intense?

    Sentiment: Strong Buy

  • Reply to

    officially confused

    by walktheline43 Apr 15, 2014 1:10 PM
    rehdvm2004 rehdvm2004 Apr 15, 2014 5:27 PM Flag

    If you want to participate in games for 2-3 years . . . follow the bozos who are doing as you describe. If you want to cash in on ARDM and Pulmoquin, buy your shares and do not sell for the targeted period for them to get really important clinical and scientific news. One facet of the diamond that is Pulmoquin was revealed in the last 48 hours. Make your choice based upon understanding the science and medicine, or playing with paper. Your choice.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    officially confused

    by walktheline43 Apr 15, 2014 1:10 PM
    rehdvm2004 rehdvm2004 Apr 15, 2014 5:23 PM Flag

    The importance of the in vitro study at Oregon State validates what I have been saying for a year. Cipro is safer than other antibiotics used to treat NTM and the inhalational route of administration is preferred in treating this disease. If you put this information side-by-side with the Insmed data on Arikace (aka, Arikayce, with the antibiotic amikacin in a liposome) ARDM is in a good position to apply with another IND with the FDA. Here is the position they take:

    1. We already have Phase IIa safety data and Phase IIb efficacy data on Pseudomonas aeruginosa.

    2. We have recently demonstrated that Cipro liposomes (Pulmoquin) is efficacious for NTM, in vitro.

    3. We want to initiate a Phase IIa (safety study) and a Phase IIb (Phase III enabling) study with Pulmquin, but with naïve NTM patients.

    INSM just completed their Phase II study with NTM patients that had to be treated with the ineffective NTM treatment regimen for six months PRIOR to going onto Arikace treatment. They met their safety endpoints but did not attain their efficacy (remission/cure) endpoints. That was because all these NTM patients had exposure to a load of antibiotics for 6 months prior to receiving Arikace. If they were naïve (first time dignosed with NTM patients) there would not have been antibiotic resistance, deep bacterial embedding in the macrophages, and minimum airway damage which allows NTM to be even more protected from antibiotic exposure. All ARDM has to do is follow in the footsteps of INSM and they will have a defined path to NTM approval.

    Besides, Pulmoquin is safe when administered with oral (systemic) Cipro. That is a trump card that is awaiting being turned over.

    Studies antibiotics under Dr. Jay Fishman at MGH. Smart cookie.

    Both Arikace and Pulmoquin are needed for NTM and each will assume its demonstrated proper place in the antibiotic regimen for treating this infection.

    GLTAL.

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Apr 15, 2014 4:36 PM Flag

    "Soon" in the heavily regulated biopharma business means after the Sponsor has met with the regulatory agency (FDA) in a non-public forum, presented their information and received comments back from the regulatory agency about interpretations of data, side effects and other IND related information. The Sponsor is always saying we have met the safety and efficacy criteria for a approval to the next phase because of X, Y, Z. When the regulatory agency responds to the presentation by the Sponsor, then a public announcement is made. Up and until the answer comes back from the regulatory agency, the Sponsor cannot say anything that is misleading under the "safe harbor/forward looking statement" limitation of SEC regulations. Then there are the adjustments to the next phase of clinical trial/submission that need to be made. WL alluded to the possibility that a Phase III was in the works. But there was a speculative statement that it might only take 3 months. This suggested to me after weighing the statements against the pathway options, that a Phase III in naïve NTM patients would be the pathway that INSM and Dr. Olivier would follow. New NTM patients show up at various clinics everyday. With (what was it? 19 med centers in the Phase II) another 100 patients could be enrolled quickly. Take heart, INSM is quite possibly near the announcement you are anticipating. We shall see.

    GLTASL

    Sentiment: Buy

  • rehdvm2004 by rehdvm2004 Apr 14, 2014 12:02 PM Flag

    From the headline, the change to Stanford Medical Center will allow access to more patients. The criteria for patient enrollment will be broadened (enrolling patients) but also narrowed (exclusion of patients). The total enrollment for the study is still listed as 15, which suggests to me that this is a "compassionate" type of protocol for patients who have not been responsive to other treatments (the article indicates there are few effective treatment. Any change like this has to be approved by the Stanford HIRB (Human Investigation Research Board) to comply with Public Health Service Policy. Because the study is not going over state lines (Sponsor and Investigating Institution are all in California) the HIRB approval is all that is needed. I think that this change indicates a Phase IIb approach. We shall see. I figured 3 years for this company and I have two more to go before I get nervous.

    Any work about Melanoma Man? He is a nice guy to share his experience with this MB and not speculate on outcome. He said the electorporation was not necessarily comfortable, but when you are staring down the ultimate statistic, a bit of discomfort does not count for much.

    GLTAL

    Sentiment: Buy

  • Reply to

    New Phase lll trial is coming

    by fdaadvisor Apr 13, 2014 9:59 AM
    rehdvm2004 rehdvm2004 Apr 13, 2014 4:56 PM Flag

    The study could get very fast consideration by the FDA depending upon what Dr. Olivier can present. I think his presentation is at the heart of this matter.

    GLTASL

    Sentiment: Buy

  • Reply to

    New Phase lll trial is coming

    by fdaadvisor Apr 13, 2014 9:59 AM
    rehdvm2004 rehdvm2004 Apr 13, 2014 4:50 PM Flag

    A quick NTM Phase III study would accrue naïve patients as fast at they can meet the minimum criteria. I think there is an estimated 50,000 NTM patients per year from various states and sources. If you calculate based upon simple math, that is more than 100 patients per month. So if the multicenter study that did the Phase II does not have to wait for the six month preliminary treatment and can accrue as patients become clinical, they could probably enroll 100 patients in a month and a few days. Then it is the duration of treatment until the patient becomes "zero" NTM. Again, without chronic infection with NTM, the build-up of mucous, the embedding in the macrophages and no conducting airway lesions forming, Arikace could have a vastly improved therapeutic index than the results of the Phase II demonstrated. But antibiotics still have to substantially kill bacteria to be labeled as an antibiotic.

    But this is a clearer study.

    GLTASL

    Sentiment: Buy

  • Reply to

    New Phase lll trial is coming

    by fdaadvisor Apr 13, 2014 9:59 AM
    rehdvm2004 rehdvm2004 Apr 13, 2014 11:00 AM Flag

    With naïve patients that have never been exposed to antibiotics before, Arikace will achieve the expected results. The Phase II study had little chance because of all the systemically administered antibiotics which only built up resistance in the NTM. If INSM/Dr. Oliver get naïve patients, the likelihood is 80% plus that they will hit all endpoints with statistical significance. The key statement by WL was (sic) that the Phase III study will take 3 months. So it sounds like the project team has convinced the FDA that with "first time infected NTM patients" they 84 day Arikace therapy would work in a highly efficacious manner. Naïve patients would have no excessive biofilm, mucous build-up or pathology. Should be a quick study. I had to do a lot of homework to figure it out, but the light came on yesterday PM. In Phase III clinical trials, all you have to do his have the product in final formulation and patients that are optimum for Rx. Just think, if patients did not have to go through even one round of the therapy that does not work . . . Arikace will have its optimum and maximum effect.

    We shall see.

    GLTASL

    Sentiment: Buy

  • will succeed because the patient enrollment population will be selected from patients that have NTM detected for the first time. Not patients enrolled after failure of the currently non-effective 6 months regimen. If NTM patients are enrolled when they first are diagnosed with three positive sputum samples, the damage to the lungs and the build-up of biofilm, infected macrophages and any associated pathology is averted. Treating this patient population should get a high order of cures and positive results (zero NTM detected and/or statistically significant NTM population reduction) well within the 84 day period.

    INSM does not want to treat more patients where Arikace rescues from failed treatments. They want to treat naïve patients that have low levels of infection, minimal biofilm/mucous build-up and minimal airway damage so the Arikace can fill the conducting airways. That will produce the cures.

    I think that might be the INSM/Dr. Olivier approach. We shall see.

    GLTASL

    Sentiment: Buy

  • Reply to

    FDA discussions will include . . .

    by rehdvm2004 Apr 9, 2014 12:24 PM
    rehdvm2004 rehdvm2004 Apr 10, 2014 12:43 PM Flag

    Do any type of a medical scientific literature search you want and show this MB any antibiotic that has been approved by the FDA in whatever time frame you want where:

    1. The antibiotic has less than a 50% bactericidal (kill/cure rate); or

    2. Less than one log reduction in bacterial count compared to a non-antibiotic placebo (e.g., 100 bacteria count being reduced to 10 bacterial count).

    Antibiotics, by definition, kill a significant number of bacteria in a patient while creating no greater risk to the patient by taking the antibiotic. That is why the Sponsor has to perform a safety and efficacy study in the target species. BTW, I was a participant in the Albion study for Burroughs Welcome back in the late 1970s. That was the first formulation of sulfa trimethoprim. EOS.

    WL is talking about a Phase III for no reason according to you and your crooked cronies. Pump away!

    Sentiment: Hold

  • Reply to

    FDA discussions will include . . .

    by rehdvm2004 Apr 9, 2014 12:24 PM
    rehdvm2004 rehdvm2004 Apr 10, 2014 11:40 AM Flag

    Here is what INSM has to figure out - even if 25% of the Control arm converting to Arikayce converts, that still means 75% are not cured. You have to look at both sides of the equation. So with a 25% cure expectation and 75% only achieving statistically insignificant NTM bacterial reduction (I would think that even a 1.0 log reduction would have been statistically significant) what doctor is going to prescribe a $30,000 treatment regimen that has less than a 50% chance of success? Medicine does have some business sense. What insurance company is going to pay 80% of that low benefit to high risk unless it is life threatening? There are lots of factors in the clinical trial, but INSM has to rely on Dr. Olivier coming up with a better treatment regimen and then they have to negotiate with the FDA. Fifty percent is a coin flip to the FDA. Many drugs have been dropped because they did not achieve better than 50% efficacy. Cancer drugs are different because of the risks of tissue invasion, metastases through the blood or metastases through the lymph.

    The NTM trial did not come out as clean and crisp as investors thought it would (me included) but that is the biopharma business. There is a reason why almost 70% of startup biopharmas fail.

    But we have to see what WL and staff come up with in the next 3-4 months. There are undoubtedly negotiations going on right now.

    GLTASL

    Sentiment: Hold

  • Reply to

    FDA discussions will include . . .

    by rehdvm2004 Apr 9, 2014 12:24 PM
    rehdvm2004 rehdvm2004 Apr 10, 2014 10:04 AM Flag

    The entire point of this thread was obvious to anyone who knows the regulatory system of drugs.

    These data are already with the FDA and the Advisory Committee for this IND. That is the only way that INSM could release any data in an Investor Presentation, which is a public document. So what is new?

    INSM talking about a Phase III study for NTM and partnering. The previous discussions and CCs from WL all pointed to expedited review and "breakthrough treatment." Now the discussion is Phase III and partnering.

    While bwd validated my point that the liposome alone has some therapeutic effect, the data do not support a strong antibiotic effect from the amikacin. That is going to be a focal point of discussion for many months.

    This same group of posters kept saying Iplex would be a Phoenix from the ashes after the dismal MMD study results. Same #$%$ keep spouting blather. It took two years for the Transave merger to reposition INSM. They had three Phase III studies almost immediately. Then the two rats with precancerous lesions that could be explained away by any competent veterinary pathologist in an instant. But it took 7 months to get back on track, with the NTM study being relegated to a Phase II (feasibility study).

    This situation is going to go on for months before it gets cleared-up. I think that INSM is going to come up with a different treatment regimen for a Phase III, because expanding on these results will not get them to an NDA.

    GLTASL

    Sentiment: Hold

  • Reply to

    Cost of study

    by justarook04 Apr 9, 2014 8:35 AM
    rehdvm2004 rehdvm2004 Apr 9, 2014 1:17 PM Flag

    The cost is not the limitation. What dose, duration of treatment and endpoint will be agreed upon with the FDA so that INSM meets their primary and secondary endpoints? Hopefully Dr. Olivier has some insights that will be written into the Phase III.

    If you look at the one Primary and the other Secondary endpoints, they all say "Safety" after the criteria. I think the NTM study was written as a Phase IIa with the hope that the therapeutic index would be so outstanding that FDA would expedite them to submit an NDA. That is not going to happen as a result of this study. But they did achieve safety.

    We shall see what appears on the horizon in the next 3-4 months.

    GLTASL

    Sentiment: Hold

  • Reply to

    FDA discussions will include . . .

    by rehdvm2004 Apr 9, 2014 12:24 PM
    rehdvm2004 rehdvm2004 Apr 9, 2014 1:01 PM Flag

    That was always the potential of the liposome. Read the patent. It included ALL aminoglycosides, floroquinolones, macrolides, etc., etc. But it also included antibodies, biological and drugs. Only one problem. For any other formulation and until INSM has its first approved product . . . the liposome is a Control Article under GLPs and FDA CMR 310 Clinical Trial regulations. A master file is for "carrier vehicles" that are proven safe, but do not necessarily have an efficacy of their own. But as I am sure posters on this MB remember, Transave did a preclinical safety study on the ability of the liposome to penetrate the biofilm and be taken up by the fixed macrophages in the lung. Anyway, it is moot because if Longs thought two precancerous lung lesions in rats caused a delay, the points I raised in this thread and that one death in the Arikayce group are going to be discussed for many months. INSM may be looking to partner to get some other projects started, or get a project started for just the mucolytic liposome. Many posters on this MB have fingers that go 60 miles an hour and brains that go less than 10 miles per hour. Thinking first is always best.

    Sentiment: Hold

  • Several points on Slide 6 in the investor's presentation including:

    "Reduction in bacterial density (numerically superior, not statistically significant)."

    Critical point of discussion with FDA. Frankly, I was totally surprised as a former investor and supporter of inhaled liposome amikacin that there was not a statistically significant reduction in at least 50% of the Arikayce patients, let alone 70% becoming negative in 30 days. There was just that much theoretical power behind WL's presentation. The slam dunk level would have been (minimally) 50% of patients would become NTM negative during the 84 day period. As it was, that got half that number (25%).

    "Culture conversions to negative in 11 out of 44 patients at Day 84 (statistically significant)."

    OK. Twenty-5% became negative after 84 days. But these data have to be explained in view of three Placebo patients that also became negative after 84 days. This is after they had received six months of currently prescribed multiple modality therapy and remained NTM culture positive. So what in the treatment regimen made these patients become negative when it did not before?

    If Longs listen to the non-scientific, non-medical interpretations of what happens event by event at INSM . . . you are tracking the wrong information. When Dr. Olivier speaks, it will be worth listening to because he is both the clinician and a scientist of record for this effort.

    My personal belief is now that the NTM data is in, amikacin may not have been the best antibiotic for Pa or NTM. There may be more efficacious antibiotics to be included in the liposome. That could also be why WL suggested INSM would be pursuing a partner. Perhaps one with a stronger in vitro therapeutic index to Pa and NTM. INSM still has a proprietary liposome, which is one-half the battle.

    We shall see, but the remaining Longs who are sane and not pumping are in the "Hold" mode again.

    Sentiment: Hold

  • culture or PCR. That would be such an obvious shortfall in the clinical trial that I doubt INSM, or NIH (Dr. Olivier) would not have planned for that question from the FDA. Remember, Dr. O is advisory to FDA. If he cannot get them to agree . . . that would really be another Moxley/MMD/Iplex repetition of history.

    Longs just have to hold so that INSM and NIH can sort out any changes they want to make in a Phase III (which now seems a possibility because the data that everyone is tossing about.

    GLTASL

    Sentiment: Hold

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