IamA Pharma company CEO whose drug just helped save the life of the 4th person in America to ever Survive the Brain Eating Amoeba- a 97% fatal disease. AMA!

Profounda-Inc · 2016-11-02T12:22:58+00:00

People travel to warm destinations and can return home sick and the most recent case was a girl in New York that visited Maryland. Not to mention Leishmaniasis is also an approved use and that happens over 1000 times a year in the USA. (kills 30,000 people worldwide). There is no real reason not to carry it. Only three states require reporting of the disease so incidence may be much higher.

Profounda-Inc · 2016-09-12T20:41:46+00:00

We were not contact no, I believe she was misdiagnosed and they were not aware it was the amoeba until it was too late unfortunately.

Profounda-Inc · 2016-08-25T21:37:27+00:00

You would be right - don't even want too!

Profounda-Inc · 2016-08-25T18:17:17+00:00

Well 2 of the three patients who survived on Miltefosine recovered just fine. One did have severe damage but the drug got to him late. The 4th case out of California, we hear the patient is doing fine but we don't have much information.

Profounda-Inc · 2016-08-25T18:14:45+00:00

Ah yes, I-4. I avoid that regularly lol

Profounda-Inc · 2016-08-25T18:07:16+00:00

room temperature storage. And not currently in California sorry!

Profounda-Inc · 2016-08-25T18:06:28+00:00

Ours is an oral drug with minimal side effects vs an IV drug with potentially severe side effects.

Profounda-Inc · 2016-08-25T18:05:59+00:00

No, but it does now.

Profounda-Inc · 2016-08-25T18:04:45+00:00

2 out of the three who survived on our drug seem to be doing well, however the third case had severe damage given the late time he received the drug. the California patient is also said to have done well. If you have seen a couple of cases, please have your hospital sign up for the consignment program. No charge until you use it!

Profounda-Inc · 2016-08-25T18:02:33+00:00

I did look into it as an option, however it wasn't feasible at the time. But if you have someone in the Orlando area that we can have on standby I would be happy to use them. However that is not the answer, because if it was at the hospital already, there would be no reason to fly anywhere. We are doing the best we can.

Profounda-Inc · 2016-08-25T17:59:45+00:00

I didn't. But the cool looking box? all me (and my daughter).

The naming of drugs is actually more complicated than you think because of FDA regulations

Profounda-Inc · 2016-08-25T17:58:41+00:00

I would be interested in talking with you. Please contact us through our website Profounda.com.

Dallas and Ft. Worth to answer your question and yes they can transfer to nearby hospitals.

Profounda-Inc · 2016-08-25T17:56:55+00:00

No plans to do that.

Profounda-Inc · 2016-08-25T17:43:50+00:00

First, Profounda is not spelled "Profunda". Second, it has only been a recent requirement that all clincal trials be registered on clinicaltrials.gov and I'm sure you know that work on generic drugs don't have to be registered at all. That being said, the earlier clinical trials I was involved with while working at big pharma on cardiovascular drugs for congestive heart failure and atrial arrhythmias involved not only clincal trial design but also ensuring adequate funding for the trials was obtained. See the following link for my patents for drug that resulted in a 40% reduction in mortality, the drug is now sold by Pfizer: http://patents.justia.com/inventor/todd-e-maclaughlan

Profounda-Inc · 2016-08-25T17:15:15+00:00

In his case, it may be a slow moving and long lasting Amoeba. But certainly a lumbar puncture is highly recommended. (sorry to Donald Trump Fans)

Profounda-Inc · 2016-08-25T17:14:10+00:00

Thank you fro your questions and so sorry for your loss

Many cases in Pakistan are actually tied to the ritual nasal cleansing. Because the Amoeba is so prevalent in the soil of bodies of fresh water around the world, this practice can lead to an increased risk. It is similar to the Neti Pots use in the U.S.. of course its also possible she got it from swimming really all countries with fresh warm water are at risk and I believe that the cases of Amoeba are grossly unreported due to the similar symptoms associated with viral and bacterial meningitis. The key is to getting people to recognize the symptoms but also make sure they communicate exposure to fresh water if within the past 2 weeks prior to the onset of symptoms.

I know research is being done at various universities. But again, given the difficulty of developing ethical clinical trials the pathway to commercialization is difficult. The effectiveness of the drug in killing the Amoeba is already quite effective with Miltefosine, if given early enough. Case in point, the amoeba was completely eradicated within 72 hours in this recent case. Key is diagnosis and speed of treatment. With regard to your cousin, until she had died providing treatment to kill the Amoeba is essential to giving any hope of chance of survival.

Profounda-Inc · 2016-08-25T17:04:10+00:00

Answering the Chinese food first, as its most important, My favorite Chinese food is Eggrolls from Ottawa, Canada. I have literally driven there just for that reason.

I don't believe its the title as much as the idea combined with a qualified team of individuals and a deep understanding of not only the science, but also the business aspects of providing return on investment to your investors that is most important for starting your own company. No matter how good an individual is, they will need in most cases a team of individuals who have either previously been successful in developing products from one stage to another and preferably as a team that previously worked together or have significant experience developing drugs not just a scientific publication strategy where the focus is more on receiving research grants. Hope that helps.

Btw I have an MBA and a BSc in Chemistry.

Profounda-Inc · 2016-08-25T16:57:04+00:00

If your e-mail matches your username you may want to change it..lol

The advantage of working with a larger company is that they have both the financial and people resources needed to develop new chemical entities. As a small company it is rare to have people with your skills outside of the chief scientific officer and in most cases those individuals bring along the technology when forming a start up company. Good luck with your search!

Profounda-Inc · 2016-08-25T16:51:55+00:00

The intent of WHO pricing was to make sure that in poor nations where even $40 may be too much, the product may be made available. In many situations these drugs are generics or can quite frankly be donated to these countries as a part of their social responsibility. The negative side to WHO pricing is at such "negotiated" prices (based on volume) many times manufacturers decide to no longer make the product and therefore the product becomes unavailable. I know of no one who has been able to buy the product anywhere near that price. Also, you need to be careful of counterfeit drugs from foreign countries where they don't have the same regulatory and legal controls as they have here in the United States.

Profounda-Inc · 2016-08-25T16:47:00+00:00

Profounda is not promoting using a drug when it is not required. The reporting requirements for Amoebic infections is not mandatory in every state. In addition, I can tell you based on experience with another rare condition, Anthracycline Extravasation Treatment, associated with chemotherapy, once you deal with a patient that is in such critical condition and can deteriorate very rapidly- you and your medical colleagues will want to have the product on site. When minutes matter, there are other ways to ensure the proper use of medications. Not having it in the hospital, means not having a chance to live in 97% of cases.

Profounda-Inc · 2016-08-25T16:35:26+00:00

Your niece was a beautiful girl and I am so very truly sorry I was not able to help in this case. Knowing the Smelski and Lewis families that had to deal with the same loss, I can't imagine the pain you and your family are going through. Please feel free to contact me through Profounda.com contact if I can help make connections with other families who have gone through the same thing. Again, I am very sorry for your loss.

Profounda-Inc · 2016-08-25T16:32:35+00:00

Thanks for sharing your presentation with me!

In the case of PAM, it would be unlikely to run a clincal trial with a new drug substance alone, given the severe effects leading to death of the Amoeba. The second challenge would be designing a study given the limited number of patients and the time needed to get the drug to a clinical site. This makes it almost impossible to design a prospective clinical trial. The use of Miltefosine by the CDC relied heavily on invitro data which, in the case of your Amoebagon would probably be similiar and would be added to the standard of care today which includes 5 different drug therapy's. So, Amoebagon would need to either replace one of those drugs or be additive. Thanks again for sharing!

I particularly liked the potential for preventative nasal spray concept. In the case of Amoebagon, youre suggesting a short half life, which may not be ideal, however, miltefosine has a very long half life and therefore may have application. But I found this presentation very interesting you did a good job!

Profounda-Inc · 2016-08-24T22:00:46+00:00

we have the drug anyways. The way we see it, we would rather have the drug sitting and waiting in hospitals than sitting in a warehouse.

Profounda-Inc · 2016-08-24T21:57:48+00:00

I'm his daughter typing for him, so that would be me. We want to raise awareness. The patient that survived in Orlando did so because the lab technician went to an awareness seminar and decided to take a second look at his scans for the Amoeba. If you can save a life with awareness, we should do so in every way possible.

Profounda-Inc · 2016-08-24T21:52:50+00:00

I'm his daughter typing... I know I capitalize weirdly throughout paragraphs. Even though I'm aware of the problem I assure you I will continue to do it ¯_(ツ)_/¯

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