Protalex Inc (PRTX) 3.3500 $PRTX
Protalex Receives Positive Interim Review from Independent Safety Monitoring Committee in Its European Phase 1b Study of PRTX-100 to Treat Immune Thrombocytopenia
BusinessWire - Mon May 02, 7:00AM CDT
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim data review by its independent Safety Monitoring Committee (SMC), the Company is continuing enrollment and increasing the dose for subjects in its European Phase 1b study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-203 Study). The dose of PRTX-100 for subjects in the next treatment group (6.0 micrograms/kg) will be twice that of the initial starting dosage (3.0 micrograms/kg).
Protalex Announces Preliminary Findings from Phase I/II Continuation Trial of PRTX-100 in Active Rheumatoid Arthritis Patients
BusinessWire - Mon Apr 25, 7:00AM CDT
Protalex, Inc. (OTCQB RTX), a clinical-stage biopharmaceutical company, today announced preliminary findings following completion of its Phase I/II open-label, single group study with former participants from its U.S.-based PRTX-100-104 Study. In this continuation study ("PRTX-100-105 Study"
, rheumatoid arthritis (RA) patients received a fixed dose of PRTX-100 over a 6-month period in combination with either methotrexate or leflunomide.
Four Biotechs To Consider On Intermediate Bottom, Trend Change Signal
ACCESSWIRE - Mon Mar 14, 9:10AM CDT
NEW YORK, NY / ACCESSWIRE / March 14, 2016 / 2015 was a wild year in biotech, with six months of sector-wide gains during January to July reversed throughout the latter half of the year on a combination of political reform expectations and US rate-hike-induced risk-off sentiment. We're nearly a full quarter into 2016, and it looks like we may have finally seen an intermediate bottom in stocks with yesterday's big up move holding today, March 2.
SQNM: 1.09 (-0.03), CDTX: 10.71 (-0.05), ATHX: 2.41 (-0.07)
Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) Therapeutic Development Pipeline Review, H2 2015
M2 - Wed Jan 27, 5:13AM CST
Research and Markets (http://www.researchandmarkets.com/research/8qf3c9/idiopathic) has announced the addition of the "Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) Overview - Therapeutics Development - Pipeline Products for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Overview - Pipeline Products for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Comparative Analysis - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Therapeutics under Development by Companies - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Therapeutics under Investigation by Universities/Institutes - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Products under Development by Companies - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Products under Investigation by Universities/Institutes - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Companies Involved in Therapeutics Development - 3SBio Inc. - Amgen Inc. - Baxalta Incorporated - Boehringer Ingelheim GmbH - Bristol-Myers Squibb Company - Eisai Co., Ltd. - Hansa Medical AB - Immunomedics, Inc. - Intas Pharmaceuticals Ltd. - Jiangsu Hengrui Medicine Co., Ltd. - Merck & Co., Inc. - Momenta Pharmaceuticals, Inc. - Novartis AG - Pfizer Inc. - PhytoHealth Corporation - Protalex, Inc. - Rigel Pharmaceuticals, Inc. For more information visit http://www.researchandmarkets.com/research/8qf3c9/idiopathic
IMMU: 3.60 (-0.28), PFE: 35.23 (+0.39), AMGN: 157.82 (-1.07), BMY: 73.52 (-0.39), RIGL: 2.42 (-0.02), MNTA: 12.10 (-0.03), MRK: 57.76 (+0.76), BXLT: 46.02 (-0.18), NVS: 81.37 (-0.24)
Protalex Announces First Patient Dosed in European Phase Ib Study of PRTX-100 for Immune Thrombocytopenia
BusinessWire - Thu Jan 07, 7:30AM CST
Protalex, Inc. (OTCQB RTX), a clinical-stage biopharmaceutical company, today announced dosing of the first patient in its European Phase Ib study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (the PRTX-100-203 Study). PRTX-100, Protalex's lead drug candidate, is a highly purified form of Staphylococcal protein A (SpA), which was granted Orphan Drug Designation in Europe and the U.S. for the treatment of ITP. A similar Phase I/II clinical study of PRTX-100 is underway in the U.S. (the PRTX-100-202 Study). PRTX-100 is also the subject of ongoing clinical development in Rheumatoid Arthritis (RA).
Protalex Could Be an Early Stage Buyout Target come February
ACCESSWIRE - Mon Nov 23, 10:00AM CST
NEW YORK, NY / ACCESSWIRE / November 23, 2015 / In the rheumatoid arthritis (RA) treatment space, Humira is king. The drug generated $11 billion revenues for AbbVie Inc. (ABBV) during 2014, accounting for more than 60% of the company's total revenues and forecast to generate between $13 billion and $18 billion by 2020. The drug is a TNF inhibitor - it binds to tumor necrosis factor-alpha (TNFα), stopping the TNFα from binding to TNFα receptors - the process that initiates the inflammatory immune response and causes RA.
Protalex Announces First Patient Dosed in U.S. Phase 1/2 Study of PRTX-100 for Immune Thrombocytopenia
BusinessWire - Mon Nov 23, 7:30AM CST
Protalex, Inc. (OTCQB RTX), a clinical-stage biopharmaceutical company, today announced that it has dosed the first patient in its U.S. Phase 1/2 study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-202 Study). PRTX-100, Protalex's lead drug candidate, is a highly purified form of Staphylococcal protein A (SpA), which was recently granted Orphan Drug Designation in the U.S. and in Europe for the treatment of ITP. PRTX-100 is also the subject of ongoing clinical development in Rheumatoid Arthritis (RA).
Protalex Announces Presentation of Preclinical Data with PRTX-100 Supporting Treatment of Immune Thrombocytopenia at the American Society of Hematology 57th Annual Meeting and Exposition
BusinessWire - Wed Nov 11, 7:30AM CST
Protalex, Inc. (OTCQB RTX), a clinical-stage biopharmaceutical company, today announced that an abstract highlighting preclinical results from a study of Staphylococcal protein A (PRTX-100) for the treatment of Immune Thrombocytopenia (ITP) will be presented at the upcoming American Society of Hematology (ASH) 57th Annual Meeting and Exposition being held in Orlando, Florida from December 5-8, 2015. The abstract is available on the ASH website at http://www.hematology.org and on the Company's website at www.protalex.com.
Protalex passes French National Agency for Medicines and Health Products' approval to begin Phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia
M2 - Tue Oct 06, 5:41AM CDT
Biopharmaceutical company Protalex (OtherOTC RTX) reported on Monday the receipt of the French National Agency for Medicines and Health Products' (ANSM) approval to begin a Phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP), an autoimmune-mediated condition characterised by bruising and increased bleeding as a result of immune-mediated accelerated destruction of platelets and impaired production of platelets.
Protalex Announces Regulatory Approval to Initiate Phase Ib Trial of PRTX-100 to Treat Immune Thrombocytopenia in France
BusinessWire - Mon Oct 05, 7:00AM CDT
Protalex, Inc. (OTCQB RTX), a clinical-stage biopharmaceutical company, announced today that the French National Agency for Medicines and Health Products (ANSM) has approved the company's clinical trial application to begin a Phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP). This approval authorizes Protalex to initiate the study (PRTX-100-203 Study) at several sites in France. The company expects to commence enrollment before year end.
Protalex to launch US Phase I/II trial of PRTX-100 in immune thrombocytopenia patients
M2 - Fri Sep 04, 3:05AM CDT
Biopharmaceutical company Protalex (Other OTC RTX) said on Thursday that it will begin enrollment under its Phase I/II study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) at several sites in the United States (the PRTX-100-202 Study) in the coming weeks.
Protalex to Initiate Enrollment of U.S. Phase I/II Trial of PRTX-100 to Treat Immune Thrombocytopenia
BusinessWire - Thu Sep 03, 7:00AM CDT
Protalex, Inc. (OTCQB RTX), a clinical-stage biopharmaceutical company, announced today that it will initiate enrollment for a Phase I/II study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) at several sites in the United States (the PRTX-100-202 Study) in the coming weeks. Protalex previously announced U.S. FDA acceptance of an Investigational New Drug application (IND) for this study. PRTX-100, Protalex's lead drug, is a new generation immunomodulatory therapy that is under investigation for autoimmune diseases such as rheumatoid arthritis (RA) and ITP. PRTX-100 is a highly purified form of Staphylococcal protein A (SpA), a bacterial protein known to modify aspects of the human immune system.
Thrombocytopenia Pipeline Review, H1 2015 - 35 Companies & 41 Drug Profiles
M2 - Fri Jul 31, 8:42AM CDT
Research and Markets (http://www.researchandmarkets.com/research/jqnh8b/thrombocytopenia) has announced the addition of the "Thrombocytopenia - Pipeline Review, H1 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Thrombocytopenia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Thrombocytopenia and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Ablynx NV - Anthera Pharmaceuticals Inc. - Archemix Corp. - Arcturus Therapeutics, Inc - aTyr Pharma, Inc. - Bayer AG - BioLineRx, Ltd. - Boehringer Ingelheim GmbH - Bolder Biotechnology, Inc. - Bristol-Myers Squibb Company - Cellerant Therapeutics, Inc. - Eisai Co., Ltd. - GlaxoSmithKline Plc - Glenmark Pharmaceuticals Ltd. - HanAll Biopharma Co., Ltd. - Immunomedics, Inc. - InvivoGen Therapeutics - Jiangsu Hengrui Medicine Co., Ltd. - Kaketsuken K.K. - Merck & Co., Inc. - Momenta Pharmaceuticals, Inc. - Myelo Therapeutics GmbH - Neumedicines Inc. - Novartis AG - Octapharma AG - Omeros Corporation - Pfizer Inc. - PhytoHealth Corporation - Portola Pharmaceuticals, Inc. - Prophylix Pharma AS - Protalex, Inc. - Rigel Pharmaceuticals, Inc. - Shionogi & Co., Ltd. - STATegics, Inc. - ViroMed Co., Ltd. Drug Profiles - Antibody for Autoimmune Disorders and Inflammation - ARC-15105 - avatrombopag - BAX-930 - BBT-030 - BBT-045 - BI-655064 - BL-8040 - blisibimod - BMS-986004 - caplacizumab - CLT-009 - eltrombopag olamine - fostamatinib disodium - GBR-600 - Gene Therapy for Chemotherapy-Induced Thrombocytopenia - GL-2045 - GSK-2285921 - Hetrombopag Olamine - HL-161 - LUNAR-TPO - lusutrombopag - MK-8723 - Monoclonal Antibody to Antagonize FcgR1 for Inflammatory and Autoimmune Disorders - Monoclonal Antibody to Antagonize FcgRIIa for Inflammatory and Autoimmune Disorders - Myelo-001 - NMIL-121 - Oligonucleotides to Activate miRNA-150 for Thrombocytopenia - OMS-721 - PEG-VM501 - PHN-013 - plasma (human) - PRT-060318 - PRTX-100 - rivaroxaban For more information visit http://www.researchandmarkets.com/research/jq...ocytopenia
IMMU: 3.60 (-0.28), PTLA: 27.20 (+0.18), PFE: 35.23 (+0.39), BMY: 73.52 (-0.39), GSK: 42.58 (-0.12), RIGL: 2.42 (-0.02), MNTA: 12.10 (-0.03), OMER: 10.93 (+0.14), ANTH: 3.76 (-0.06), MRK: 57.76 (+0.76), NVS: 81.37 (-0.24)
This is Why the Orphan Drug Space is Easing Worries About Broader Biotech Bubble
ACCESSWIRE - Thu Jul 23, 7:00AM CDT
CORAL GABLES, FL / ACCESSWIRE / July 23, 2015 / Since July 2010, the iShares Nasdaq Biotechnology ETF (IBB) has gained more than 370%, rising from $77 on July 12, 2010 to June 2015 highs of $377 a share. A number of leading news media outlets are starting to report that we are in the midst of a biotech bubble, and that this bubble looks set to burst before the end of the year. This is not to say, however, that there are not opportunities in the space going forward.
RTRX: 18.31 (-0.01), LPCN: 8.85 (+0.10), LBIO: 7.92 (-0.10)
Protalex Announces Listing on OTCQB Exchange
BusinessWire - Mon Jul 20, 12:12PM CDT
Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, announces that it has been listed for trading on the OTCQB(R) Market exchange in the United States under the symbol "PRTX."
Protalex wins US FDA's orphan drug designation for PRTX-100 to treat immune thrombocytopenia
M2 - Wed Jun 17, 4:25AM CDT
Biopharmaceutical company Protalex (OtherOTC RTX) disclosed on Tuesday the receipt of orphan drug designation from the US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for PRTX-100 for the treatment of immune thrombocytopenia (ITP).
Protalex Receives Orphan Drug Designation from FDA for PRTX-100 to Treat Immune Thrombocytopenia
BusinessWire - Tue Jun 16, 7:30AM CDT
Protalex, Inc. (OTCQB RTX), 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.
Protalex Announces Findings from Final Cohort of U.S. Phase 1b Trial of PRTX-100 in Active Rheumatoid Arthritis Patients
BusinessWire - Thu Apr 16, 7:30AM CDT
Protalex, Inc. (OTCQB RTX), a clinical-stage biopharmaceutical company, announced that it has completed analysis from the final cohort (Cohort 5) of its U.S.-based multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (RA; the 104 Study). PRTX-100, Protalex's lead drug, is a highly purified form of Staphylococcal Protein A, which is the subject of ongoing clinical development in rheumatoid arthritis RA. Under a separate Investigational New Drug application, the Company will soon commence a clinical trial of PRTX-100 in patients suffering from chronic Immune Thrombocytopenia (ITP), an orphan disease.
Protalex Receives Positive Interim Review from Independent Safety Monitoring Committee in Its European Phase 1b Study of PRTX-100 to Treat Immune Thrombocytopenia
BusinessWire - Mon May 02, 7:00AM CDT
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim data review by its independent Safety Monitoring Committee (SMC), the Company is continuing enrollment and increasing the dose for subjects in its European Phase 1b study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-203 Study). The dose of PRTX-100 for subjects in the next treatment group (6.0 micrograms/kg) will be twice that of the initial starting dosage (3.0 micrograms/kg). Protalex Announces Preliminary Findings from Phase I/II Continuation Trial of PRTX-100 in Active Rheumatoid Arthritis Patients
BusinessWire - Mon Apr 25, 7:00AM CDT
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, today announced preliminary findings following completion of its Phase I/II open-label, single group study with former participants from its U.S.-based PRTX-100-104 Study. In this continuation study ("PRTX-100-105 Study" , rheumatoid arthritis (RA) patients received a fixed dose of PRTX-100 over a 6-month period in combination with either methotrexate or leflunomide. Four Biotechs To Consider On Intermediate Bottom, Trend Change Signal
ACCESSWIRE - Mon Mar 14, 9:10AM CDT
NEW YORK, NY / ACCESSWIRE / March 14, 2016 / 2015 was a wild year in biotech, with six months of sector-wide gains during January to July reversed throughout the latter half of the year on a combination of political reform expectations and US rate-hike-induced risk-off sentiment. We're nearly a full quarter into 2016, and it looks like we may have finally seen an intermediate bottom in stocks with yesterday's big up move holding today, March 2.
SQNM: 1.09 (-0.03), CDTX: 10.71 (-0.05), ATHX: 2.41 (-0.07)
Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) Therapeutic Development Pipeline Review, H2 2015
M2 - Wed Jan 27, 5:13AM CST
Research and Markets (http://www.researchandmarkets.com/research/8qf3c9/idiopathic) has announced the addition of the "Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) Overview - Therapeutics Development - Pipeline Products for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Overview - Pipeline Products for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Comparative Analysis - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Therapeutics under Development by Companies - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Therapeutics under Investigation by Universities/Institutes - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Products under Development by Companies - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Products under Investigation by Universities/Institutes - Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) - Companies Involved in Therapeutics Development - 3SBio Inc. - Amgen Inc. - Baxalta Incorporated - Boehringer Ingelheim GmbH - Bristol-Myers Squibb Company - Eisai Co., Ltd. - Hansa Medical AB - Immunomedics, Inc. - Intas Pharmaceuticals Ltd. - Jiangsu Hengrui Medicine Co., Ltd. - Merck & Co., Inc. - Momenta Pharmaceuticals, Inc. - Novartis AG - Pfizer Inc. - PhytoHealth Corporation - Protalex, Inc. - Rigel Pharmaceuticals, Inc. For more information visit http://www.researchandmarkets.com/research/8qf3c9/idiopathic
IMMU: 3.60 (-0.28), PFE: 35.23 (+0.39), AMGN: 157.82 (-1.07), BMY: 73.52 (-0.39), RIGL: 2.42 (-0.02), MNTA: 12.10 (-0.03), MRK: 57.76 (+0.76), BXLT: 46.02 (-0.18), NVS: 81.37 (-0.24)
Protalex Announces First Patient Dosed in European Phase Ib Study of PRTX-100 for Immune Thrombocytopenia
BusinessWire - Thu Jan 07, 7:30AM CST
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, today announced dosing of the first patient in its European Phase Ib study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (the PRTX-100-203 Study). PRTX-100, Protalex's lead drug candidate, is a highly purified form of Staphylococcal protein A (SpA), which was granted Orphan Drug Designation in Europe and the U.S. for the treatment of ITP. A similar Phase I/II clinical study of PRTX-100 is underway in the U.S. (the PRTX-100-202 Study). PRTX-100 is also the subject of ongoing clinical development in Rheumatoid Arthritis (RA). Protalex Could Be an Early Stage Buyout Target come February
ACCESSWIRE - Mon Nov 23, 10:00AM CST
NEW YORK, NY / ACCESSWIRE / November 23, 2015 / In the rheumatoid arthritis (RA) treatment space, Humira is king. The drug generated $11 billion revenues for AbbVie Inc. (ABBV) during 2014, accounting for more than 60% of the company's total revenues and forecast to generate between $13 billion and $18 billion by 2020. The drug is a TNF inhibitor - it binds to tumor necrosis factor-alpha (TNFα), stopping the TNFα from binding to TNFα receptors - the process that initiates the inflammatory immune response and causes RA.
Protalex Announces First Patient Dosed in U.S. Phase 1/2 Study of PRTX-100 for Immune Thrombocytopenia
BusinessWire - Mon Nov 23, 7:30AM CST
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, today announced that it has dosed the first patient in its U.S. Phase 1/2 study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-202 Study). PRTX-100, Protalex's lead drug candidate, is a highly purified form of Staphylococcal protein A (SpA), which was recently granted Orphan Drug Designation in the U.S. and in Europe for the treatment of ITP. PRTX-100 is also the subject of ongoing clinical development in Rheumatoid Arthritis (RA). Protalex Announces Presentation of Preclinical Data with PRTX-100 Supporting Treatment of Immune Thrombocytopenia at the American Society of Hematology 57th Annual Meeting and Exposition
BusinessWire - Wed Nov 11, 7:30AM CST
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, today announced that an abstract highlighting preclinical results from a study of Staphylococcal protein A (PRTX-100) for the treatment of Immune Thrombocytopenia (ITP) will be presented at the upcoming American Society of Hematology (ASH) 57th Annual Meeting and Exposition being held in Orlando, Florida from December 5-8, 2015. The abstract is available on the ASH website at http://www.hematology.org and on the Company's website at www.protalex.com. Protalex passes French National Agency for Medicines and Health Products' approval to begin Phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia
M2 - Tue Oct 06, 5:41AM CDT
Biopharmaceutical company Protalex (OtherOTC
RTX) reported on Monday the receipt of the French National Agency for Medicines and Health Products' (ANSM) approval to begin a Phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP), an autoimmune-mediated condition characterised by bruising and increased bleeding as a result of immune-mediated accelerated destruction of platelets and impaired production of platelets. Protalex Announces Regulatory Approval to Initiate Phase Ib Trial of PRTX-100 to Treat Immune Thrombocytopenia in France
BusinessWire - Mon Oct 05, 7:00AM CDT
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, announced today that the French National Agency for Medicines and Health Products (ANSM) has approved the company's clinical trial application to begin a Phase Ib study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP). This approval authorizes Protalex to initiate the study (PRTX-100-203 Study) at several sites in France. The company expects to commence enrollment before year end. Protalex to launch US Phase I/II trial of PRTX-100 in immune thrombocytopenia patients
M2 - Fri Sep 04, 3:05AM CDT
Biopharmaceutical company Protalex (Other OTC
RTX) said on Thursday that it will begin enrollment under its Phase I/II study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) at several sites in the United States (the PRTX-100-202 Study) in the coming weeks. Protalex to Initiate Enrollment of U.S. Phase I/II Trial of PRTX-100 to Treat Immune Thrombocytopenia
BusinessWire - Thu Sep 03, 7:00AM CDT
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, announced today that it will initiate enrollment for a Phase I/II study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) at several sites in the United States (the PRTX-100-202 Study) in the coming weeks. Protalex previously announced U.S. FDA acceptance of an Investigational New Drug application (IND) for this study. PRTX-100, Protalex's lead drug, is a new generation immunomodulatory therapy that is under investigation for autoimmune diseases such as rheumatoid arthritis (RA) and ITP. PRTX-100 is a highly purified form of Staphylococcal protein A (SpA), a bacterial protein known to modify aspects of the human immune system. Thrombocytopenia Pipeline Review, H1 2015 - 35 Companies & 41 Drug Profiles
M2 - Fri Jul 31, 8:42AM CDT
Research and Markets (http://www.researchandmarkets.com/research/jqnh8b/thrombocytopenia) has announced the addition of the "Thrombocytopenia - Pipeline Review, H1 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Thrombocytopenia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Thrombocytopenia and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Ablynx NV - Anthera Pharmaceuticals Inc. - Archemix Corp. - Arcturus Therapeutics, Inc - aTyr Pharma, Inc. - Bayer AG - BioLineRx, Ltd. - Boehringer Ingelheim GmbH - Bolder Biotechnology, Inc. - Bristol-Myers Squibb Company - Cellerant Therapeutics, Inc. - Eisai Co., Ltd. - GlaxoSmithKline Plc - Glenmark Pharmaceuticals Ltd. - HanAll Biopharma Co., Ltd. - Immunomedics, Inc. - InvivoGen Therapeutics - Jiangsu Hengrui Medicine Co., Ltd. - Kaketsuken K.K. - Merck & Co., Inc. - Momenta Pharmaceuticals, Inc. - Myelo Therapeutics GmbH - Neumedicines Inc. - Novartis AG - Octapharma AG - Omeros Corporation - Pfizer Inc. - PhytoHealth Corporation - Portola Pharmaceuticals, Inc. - Prophylix Pharma AS - Protalex, Inc. - Rigel Pharmaceuticals, Inc. - Shionogi & Co., Ltd. - STATegics, Inc. - ViroMed Co., Ltd. Drug Profiles - Antibody for Autoimmune Disorders and Inflammation - ARC-15105 - avatrombopag - BAX-930 - BBT-030 - BBT-045 - BI-655064 - BL-8040 - blisibimod - BMS-986004 - caplacizumab - CLT-009 - eltrombopag olamine - fostamatinib disodium - GBR-600 - Gene Therapy for Chemotherapy-Induced Thrombocytopenia - GL-2045 - GSK-2285921 - Hetrombopag Olamine - HL-161 - LUNAR-TPO - lusutrombopag - MK-8723 - Monoclonal Antibody to Antagonize FcgR1 for Inflammatory and Autoimmune Disorders - Monoclonal Antibody to Antagonize FcgRIIa for Inflammatory and Autoimmune Disorders - Myelo-001 - NMIL-121 - Oligonucleotides to Activate miRNA-150 for Thrombocytopenia - OMS-721 - PEG-VM501 - PHN-013 - plasma (human) - PRT-060318 - PRTX-100 - rivaroxaban For more information visit http://www.researchandmarkets.com/research/jq...ocytopenia
IMMU: 3.60 (-0.28), PTLA: 27.20 (+0.18), PFE: 35.23 (+0.39), BMY: 73.52 (-0.39), GSK: 42.58 (-0.12), RIGL: 2.42 (-0.02), MNTA: 12.10 (-0.03), OMER: 10.93 (+0.14), ANTH: 3.76 (-0.06), MRK: 57.76 (+0.76), NVS: 81.37 (-0.24)
This is Why the Orphan Drug Space is Easing Worries About Broader Biotech Bubble
ACCESSWIRE - Thu Jul 23, 7:00AM CDT
CORAL GABLES, FL / ACCESSWIRE / July 23, 2015 / Since July 2010, the iShares Nasdaq Biotechnology ETF (IBB) has gained more than 370%, rising from $77 on July 12, 2010 to June 2015 highs of $377 a share. A number of leading news media outlets are starting to report that we are in the midst of a biotech bubble, and that this bubble looks set to burst before the end of the year. This is not to say, however, that there are not opportunities in the space going forward.
RTRX: 18.31 (-0.01), LPCN: 8.85 (+0.10), LBIO: 7.92 (-0.10)
Protalex Announces Listing on OTCQB Exchange
BusinessWire - Mon Jul 20, 12:12PM CDT
Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, announces that it has been listed for trading on the OTCQB(R) Market exchange in the United States under the symbol "PRTX."
Protalex wins US FDA's orphan drug designation for PRTX-100 to treat immune thrombocytopenia
M2 - Wed Jun 17, 4:25AM CDT
Biopharmaceutical company Protalex (OtherOTC
RTX) disclosed on Tuesday the receipt of orphan drug designation from the US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for PRTX-100 for the treatment of immune thrombocytopenia (ITP). Protalex Receives Orphan Drug Designation from FDA for PRTX-100 to Treat Immune Thrombocytopenia
BusinessWire - Tue Jun 16, 7:30AM CDT
Protalex, Inc. (OTCQB
RTX), 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. Protalex Announces Findings from Final Cohort of U.S. Phase 1b Trial of PRTX-100 in Active Rheumatoid Arthritis Patients
BusinessWire - Thu Apr 16, 7:30AM CDT
Protalex, Inc. (OTCQB
RTX), a clinical-stage biopharmaceutical company, announced that it has completed analysis from the final cohort (Cohort 5) of its U.S.-based multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (RA; the 104 Study). PRTX-100, Protalex's lead drug, is a highly purified form of Staphylococcal Protein A, which is the subject of ongoing clinical development in rheumatoid arthritis RA. Under a separate Investigational New Drug application, the Company will soon commence a clinical trial of PRTX-100 in patients suffering from chronic Immune Thrombocytopenia (ITP), an orphan disease. 
