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New treatment - Protalex

  • Sandi
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  • Sandi Forum Moderator Diagnosed in 1998, currently in remission. Diagnosed with Lupus in 2006. Last Count - 344k - 6-9-18
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9 years 7 months ago - 9 years 7 months ago #49971 by Sandi
New treatment - Protalex was created by Sandi
FLORHAM PARK, N.J.-- Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to PRTX-100 for the treatment of immune thrombocytopenia (ITP). The OOPD is tasked with evaluating the scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. PRTX-100, Protalex’s lead product, is a highly purified form of Staphylococcal Protein A. The FDA previously accepted the Company’s Investigational New Drug (IND) application for a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP. Protalex expects to enroll its first patient in an ITP study in the third quarter of 2015.

Orphan drug designation provides certain exclusivity benefits, tax credits for certain research and a waiver of the New Drug Application user fee. ITP is recognized by the FDA as an orphan disease, usually defined as a condition that affects fewer than 200,000 people nationwide.

ITP is an autoimmune-mediated condition characterized by bruising and increased bleeding as a result of immune-mediated accelerated destruction of platelets and impaired production of platelets. The diagnosis of ITP is based upon a low platelet count, usually less than 100,000 per microliter of blood, in the absence of other possible causes of reduced platelet numbers such as an underlying illness or medication.

“The FDA’s timely approval of our request for orphan drug designation for PRTX-100 to treat ITP is a key milestone that supports our broader strategy of bringing this potentially life-saving therapy to patients with ITP,” stated William E. Gannon, M.D., Chief Medical Officer of Protalex. “ITP is a chronic, debilitating disease. There are patients who do not respond to current treatment options or cannot maintain an increased platelet count requiring ongoing or additional treatment. Patients may also experience adverse events or are unable to tolerate current therapies, limiting their ability to continue treatment. So there is a need for new agents that treat the underlying mechanisms of ITP and provide effective, safe and well tolerated treatments that are also convenient for patients with ITP. We look forward to enrolling patients in our Phase I/II clinical trials of PRTX-100 to treat patients with ITP and expect to have top-line data in 2016.”

The two most recently approved drugs used to treat ITP, Nplate® (romiplostin) and Promacta®(eltrombopag) both increase the production of platelets but do not appear to affect the underlying platelet destruction process. In contrast, pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets. Furthermore, PRTX-100 has established an acceptable safety profile based on data from patients treated in five clinical studies including patients with Rheumatoid Arthritis (RA), another autoimmune disease.

About Protalex, Inc.

Protalex, Inc. is a clinical-stage biopharmaceutical company focused on the development of a class of drugs for treating autoimmune and inflammatory diseases including Rheumatoid Arthritis (RA) and Immune Thrombocytopenia (ITP). Protalex’s lead product, PRTX-100, is a formulation of a proprietary, highly purified form of Staphylococcal Protein A, which is an immunomodulatory protein produced by bacteria. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes. The safety, tolerability and pharmacokinetics of PRTX-100 have been characterized in five clinical studies. In two Phase 1b clinical trials in adult patients with active RA, PRTX-100 was generally safe and well tolerated at all dose levels, and at certain higher doses, more patients showed improvement in measures of RA disease activity than did patients at the lower dose or placebo cohorts.

www.protalex.com/news/press-releases/detail/377/protalex-receives-orphan-drug-designation-from-fda-for
The following user(s) said Thank You: rpetzel, EmilyK, Fervenz, cindyfrye, sheri

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9 years 3 months ago #51626 by MDgal
Replied by MDgal on topic New treatment - Protalex
This sounds very promissing

"With man this is impossible, but not with God; all things are possible with God." - Matthew 19:26

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7 years 5 months ago #60254 by AnneMarie P
Replied by AnneMarie P on topic New treatment - Protalex
Does anybody know how this clinical trial is going?

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7 years 4 months ago #60941 by jfitzalan
Replied by jfitzalan on topic New treatment - Protalex
The company said they are dosing the third cohorts in the US and European studies; patients in both of the first 2 dosing cohorts had a response, but they only had a very small number of patients trying

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7 years 4 months ago #61046 by RayshesMum
Replied by RayshesMum on topic New treatment - Protalex
The UK phase 1 trial starts tomorrow so has not been closed

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  • mrsb04
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  • ITP since 2014. Retired nurse. My belief is empower patients to be involved as much as possible in their care. Read, read, read & ALWAYS question medics about the evidence base they use.
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7 years 4 months ago #61047 by mrsb04
The following user(s) said Thank You: apantoj1

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  • thomaskm
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  • Male 69 Diag. April 2017 in ER with Petechiae from knees to toes 4 oral cheek blood blisters 3000 count. 3-IVIG rescues, 4, 4 day 40mg Dexamethadrone blasts. Best read 416,000 11/24/2020 (Covid+ bump) On Nplate maintenance every 3 weeks
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6 years 5 months ago #64341 by isha
Ayurvedic treatment is ancient treatment for any disease which help to cure from any problem

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5 years 8 months ago - 5 years 8 months ago #66755 by apantoj1
Replied by apantoj1 on topic New treatment - Protalex
Thanks for the info. I’ve been on NPlate since November 2017 after splenectomy. Good to know there’s other treatment in case one won’t work.
Aside from ITP for almost 30 years. I also was diagnosed with Lupus in May 2018 and on Cellcept since then.

Allie2

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  • Cindy1
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  • For 7 months, platelets crashed (as low as 1,000) every 10 days between IVIG treatments. I got cured 10/2017 after taking parasite destroying medicine and Rife US tx.
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2 months 1 week ago #73754 by Cindy1
Replied by Cindy1 on topic New treatment - Protalex
Just in case this can help even one PDSA member, I think it is important share my ITP issue. I had a diagnosis of ITP for 8 months in 2017 with platelets crashing to as low as 1,000 and needed IVIG and decadron, etc to keep me from bleeding out. FYI, my ITP occurred one month after I rode horses in the jungle of Costa Rica. I went to a great University hospital Dr. and to a large well known clinic hematologist and these specialists said I'll have ITP forever. The great news is they were WRONG! I was cured in 1 month by a homeopathic dr who did rife therapy and after I took over the counter antiparasite medication. I have not had ITP since 2017. Hopefully this information is helpful. 

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