Protalex, Inc.

Name: Protalex, Inc.
Address: Philadelphia, PA, US
Telephone: (215) 862-9720
Price range: $$

Protalex, Inc. (OTCQB: PRTX) is focused on the development of a class of drugs for treating a wide array of autoimmune and inflammatory diseases.

(OTCQB: PRTX) is a clinical-stage biopharmaceutical company focused on the development of a class of drugs for treating a wide array of autoimmune and inflammatory diseases, including rheumatoid arthritis. Protalex’s lead product, PRTX-100, is derived from bacteria that are known to circumvent aspects of the human immune system. PRTX-100 is a formulation of a proprietary, highly purified form of t

he Staphylococcal Protein A, which is an immunomodulatory protein produced by Staphylococcus aureus bacteria. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes that mediate inflammation in certain autoimmune diseases. Laboratory studies indicate that the mechanism involves interaction with specific immunologic signaling pathways. Pre-clinical animal studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects in certain models of immune mediated inflammatory diseases. To date, human clinical studies indicate that PRTX-100 is generally safe and well tolerated at all dose levels evaluated.

06/15/2018

Protalex today announced that data highlighting results from its European Phase 1b open-label, dose-escalation study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) (the PRTX-100-203 Study) were presented in a poster today at the European Hematology Association 23rd Annual Meeting underway in Stockholm. The poster, entitled “A Phase 1B Open-Label Dose-Escalation Study of PRTX-100, a Highly Purified Form of Staphylococcal Protein A (SpA), in Adult Patients with Persistent/Chronic Immune Thrombocytopenia,” was presented by a principal investigator for the 203 Study, Dr. Nicola Cooper, Hammersmith Hospital, London. For more details:

FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, today announced that data highlighting results from its European Phase 1b open-label, dose-escalation study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (I...

06/12/2018

Protalex today announced preliminary findings that its lead drug candidate PRTX-100 reduced disease activity in a second, confirmatory mouse study of myasthenia gravis (MG), an autoimmune disorder mediated by anti-self antibodies that react with the neuromuscular junction. The study was conducted by the Laboratory for Myasthenia Gravis Research at George Washington University, Washington, D.C. “We are encouraged by the data readout on our second confirmatory preclinical study for PRTX-100 in MG and hope to use it to advance our path to clinical development in this indication,” said Michelle D. Catalina, PhD., Preclinical Director of Protalex. Read the release for details:

FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, today announced preliminary findings that its lead drug candidate PRTX-100 reduced disease activity in a second, confirmatory mouse study of myasthenia gravis (MG), an autoimmune disorder m...

05/17/2018

Protalex today announced that preliminary results from its European Phase 1b open-label, dose-escalation study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) (PRTX-100-203 Study) will be presented at the upcoming European Hematology Association (EHA) 23rd Annual Meeting being held in in Stockholm from June 14-17, 2018. The 203 Study has recently completed enrollment; safety and platelet count data will be presented from all patients enrolled. The abstract is available on the EHA website at www.ehaweb.org and on the Company’s website at www.protalex.com.

FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, today announced that preliminary results from its European Phase 1b open-label, dose-escalation study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) (P...

04/09/2018

Protalex today announced that the Company has enrolled the first of three patients in cohort four of its U.S./U.K. Phase 1/2 trial evaluating PRTX-100 for the treatment of adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-202 Study). “We are excited to open cohort four in the U.S. and UK, as it demonstrates progress in our evaluation of PRTX-100 in the treatment of ITP, a serious condition that is still under-served from a therapeutic perspective. Opening additional clinical sites in the U.K. will facilitate increased enrollment, and support trial completion within the next several months,” said Richard J. Francovitch, Ph.D., Protalex’s Vice President, ITP Programs.

FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, today announced that the Company has enrolled the first of three patients in cohort four of its U.S./U.K. Phase 1/2 trial evaluating PRTX-100 for the treatment of adults with persistent/ch...

03/01/2018

Protalex Announces Completion of $1.425 Million Private Placement, Recapitalization and Entry Into Call Option Agreement With Its Principal Stockholder

FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, today announced that on February 28, 2018, it consummated a private placement financing to accredited investors of $1.425 million of Senior Convertible Notes. No commissions were payable i...

01/18/2018

Protalex has initiated enrollment in the fifth and final cohort of its European Phase 1B study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP). The first patient in this final cohort was recently dosed in the United Kingdom at 24.0 µg/kg, the highest dose used in any clinical trial to date. Read the release for details:

FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim analysis of data from the fourth dose cohort of its European Phase 1b study of PRTX-100 (PRTX-100-203 Study) in adults with persistent/chro...

11/13/2017

Protalex has initiated enrollment in the fourth cohort of its European Phase 1B study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-203 Study). The first patient in this penultimate cohort was recently dosed in the United Kingdom at 18.0 µg/kg, the highest dose of PRTX-100 used in any clinical trial to date. For details please visit:

Protalex today announced the Company has initiated enrollment in the fourth cohort of this dose-escalating study.

10/26/2017

Protalex today announced that preclinical data showing its lead drug candidate PRTX-100 increases blood platelet counts in a murine model of immune thrombocytopenia (ITP) were published in the recent issue of the peer-reviewed journal, British Journal of Haematology, in an article titled, “A highly purified form of Staphylococcal protein A alleviates murine immune thrombocytopenia.” Read the full release for details: http://bit.ly/2yO3q2q

Protalex Announces Publication in the British Journal of Haematology Supporting the Potential of PRTX-100 to Treat Immune Thrombocytopenia. FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, announces that preclinical data ...

08/29/2017

Protalex today announced that following a planned interim analysis of data from the second dose cohort of its European Phase 1b study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP), the Company has initiated enrollment in the third cohort of this dose-escalating study. The first patient in the third cohort was recently dosed at 12.0 µg/kg, double that of the second dose cohort of 6.0 µg/kg. Richard J. Francovitch, Ph.D., Vice President, ITP Programs at Protalex, commented, “Initiating the third dose cohort of the PRTX-100-203 Study is an important milestone as Protalex evaluates the activity of PRTX-100 across a broad range of doses."

Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim analysis of data from the second dose cohort of its European Phase 1b study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-203 Study), the...

08/17/2017

Protalex has been awarded a $403,000 grant from the U.S. Food and Drug Administration Office of Orphan Products Development (OOPD) to support future clinical development activity of PRTX-100 as a treatment for Immune Thrombocytopenia (ITP). Protalex President, Arnold P. Kling, commented, "The FDA provides grants for clinical studies on safety and/or effectiveness that will hopefully result in or substantially contribute to market approval of these candidate drugs. Given that this FDA program has been used in the past to bring more than 60 drugs to market, we are encouraged by their support and the promise that PRTX-100 holds in treating ITP as well as other autoimmune diseases." Read the full release for details:

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 awarded the Company a $403,000 grant to support future clinical development activity of PRTX-100 as a treatment f...

08/01/2017

Protalex today announced that following completion of a planned interim analysis of safety and efficacy data from the second dose cohort, the Company is escalating the dose of PRTX-100 in its U.S. Phase 1/2 study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP). Dr. Richard Francovitch, Protalex’s VP ITP Programs, commented, "Protalex is pleased that patient enrollment into the second dose cohort of the PRTX-100-202 Study has been completed and that one patient from the cohort responded to treatment with PRTX-100. Since responses have been observed in each of the completed cohorts, we look forward to the results of treatment in the new cohort as Protalex evaluates the activity of PRTX-100 across a broad range of doses." Read the full release for details:

FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, today announced that following completion of a planned interim analysis of safety and efficacy data from the second dose cohort, the Company is escalating the dose of PRTX-100 in ...

06/07/2017

President & CEO, Arnold P. Kling issued a Letter to Shareholders providing a business update. "Protalex started 2017 with several advances to our global clinical development programs of our lead product, PRTX-100, a highly-purified form of Staphylococcal protein A (SpA), as a potentially safe and effective new treatment for autoimmune diseases, that position us for continued advancement throughout the balance of the year and beyond," noted Kling. Click to read the full Shareholder Letter.

Protalex Issues Letter to Shareholders. FLORHAM PARK, N.J.--(BUSINESS WIRE)-- Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, announces that Arnold P. Kling, President, and Chief Executive Officer of Protalex, has issued a Letter to Shareholders providing a business ...

Address

Philadelphia, PA

Telephone

(215) 862-9720

Website

http://protalex.com/

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