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Press Release

Orlando patient survives Primary Amebic Meningoencephalitis (PAM) using Profounda's drug Impavido® (miltefosine)

Posted on: 24 Aug 16

PR Newswire

ORLANDO, Fla., Aug. 24, 2016

ORLANDO, Fla., Aug. 24, 2016 /PRNewswire/ -- Profounda, Inc. ("Profounda") announced today that the drug Impavido® (miltefosine) was used to successfully treat 16 year old patient Sebastian DeLeon at Florida Hospital for Children, in Orlando with an infection of Naegleria fowleri (commonly known as the "Brain eating Amoeba"). Impavido is the first and only oral treatment for visceral, mucosal and cutaneous leishmaniasis (a rare tropical parasitic disease) approved by the U.S. Food and Drug Administration ("FDA") and the first Rx product launched in the U.S. by Profounda, Inc.  Leishmaniasis is the second leading parasitic cause of death in the world after malaria and is rare in the USA but we see 15-30 cases per year.  Recently, Impavido has been recommended by the CDC for treating Primary Amebic Meningoencephalitis (PAM), the brain infection caused by the water-born amoeba Naegleria fowleri.

From 2005 to 2014, 35 PAM infections have been reported in the United States. All but two of these cases were fatal - the two survivors were on miltefosine. The Orlando patient is the third time miltefosine has been used to treat Naegleria fowleri in the United States successfully, showing promise in Impavido's capability to treat this rare-but deadly disease.  So far this year, we are aware of three deaths tied with PAM and the brain eating amoeba in the United States.  Miltefosine has also been used previously to successfully treat patients infected with Balamuthia and disseminated Acanthamoeba infection, two other FLA infections.  Until recently, miltefosine was only available through the Centers for Disease Control and Prevention (CDC) and had to be shipped to hospitals on a patient-by-patient basis often taking too long to reach the patient in time to help.  Access to Miletofosine in a timely manner is crucial. Profounda's headquarters in Orlando, Florida was in this case able to get Miltefosine to the Orlando patient within 30 minutes after the initial call to the company, which combined with the rapid diagnosis by the medical team led to a successful outcome.

In order to ensure that Miltefosine is available to patients who need it, Profounda created a consignment program for hospitals that allows them to keep the drug on hand at no cost to the hospital until the drug is used. So far, six hospitals carry the potentially life saving drug.

"We want to raise awareness of Free Living Amoeba (FLA) by working closely with the Jordan Smelski Foundation for Amoeba Awareness in Orlando and the Kyle Lewis Amoeba Awareness Foundation in Texas," Profounda CEO, Todd MacLaughlan stated, "While there is a low incidence of patients, without prompt treatment the condition is deadly. PAM symptoms mimic those of viral and bacterial meningitis, with proper knowledge and the drug on hand, we believe lives can be saved. That's why we are making it available to hospitals at no cost until the drug is needed. Once Naegleria fowleri is suspected, time can't be wasted in sourcing and transporting treatment."

Miltefosine achieves a high concentration of the active drug in the brain tissue as a result of excellent passage through the brain-blood barrier. Miltefosine is an alkylphosphocholine compound originally developed as an anticancer drug, which is now established as an effective anti-leishmanial therapy.  It acts on key enzymes involved in phospholipid and sterol biosynthesis, suggesting that the cell membrane is its main target.

"We could not be happier for this recent patient and their family," says Todd MacLaughlan, CEO of Profounda.  "This case confirms that having Impavido (miltefosine) readily available at the hospital and with early diagnosis and treatment, that we can provide hope for attaining a clinical cure for an otherwise lethal condition."

Clinicians can find out more about how to order Impavido for their patients or how to have the ability to have Impavido on consignment at their hospital by visiting

About Impavido® (miltefosine)

Impavido® (miltefosine) is an FDA-approved, oral treatment for visceral, mucosal and cutaneous leishmaniasis in patients 12 years of age and older.  In is currently used off label for PAM.  Please see Full Prescribing Information on for complete information. In the United States, leishmaniasis may be seen in returning travelers following exposure in endemic regions, and in American soldiers serving in Asia and the Middle East.

Miltefosine is an alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. Miltefosine was included in the WHO essential medicines list as an anti-leishmaniasis medicine in March 2011.

About Profounda, Inc.

Profounda is a product-oriented, privately backed pharmaceutical company that aims to license or develop high quality specialty niche pharmaceutical products in both the branded and generic pharmaceutical or OTC markets. Our objective is to focus on bringing high quality innovative options to patients being treated for various conditions in order to improve the lives of those that take our medication.  Profounda's first commercial OTC products, Rhinase® Nasal Gel and Rhinase® Nasal Mist, help patients with nasal dryness associated with allergies.  Profounda is also developing a potential first to file generic product competing in a $100+ million brand market. For more information, visit Profounda's website at

For further information please contact:

Profounda, Inc.
Todd MacLaughlan
Chief Executive Officer
Tel: 407-270-7792
Website: //

Steve & Shelly Smelski

Jeremy & Julie Lewis

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SOURCE Profounda, Inc.

PR Newswire

Last updated on: 24/08/2016

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