0001144204-14-038936.txt : 201406260001144204-14-038936.hdr.sgml : 2014062620140623080415ACCESSION NUMBER:0001144204-14-038936CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:27CONFORMED PERIOD OF REPORT:20140623ITEM INFORMATION:Other EventsITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20140623DATE AS OF CHANGE:20140623

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:PROTALEX INCCENTRAL INDEX KEY:0001099215STANDARD INDUSTRIAL CLASSIFICATION:SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731]IRS NUMBER:912003490STATE OF INCORPORATION:DEFISCAL YEAR END:0531

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:000-28385FILM NUMBER:14934175

BUSINESS ADDRESS:STREET 1:131 COLUMBIA TURNPIKESTREET 2:SUITE 1CITY:FLORHAM PARKSTATE:NJZIP:07932BUSINESS PHONE:215-862-9720

MAIL ADDRESS:STREET 1:131 COLUMBIA TURNPIKESTREET 2:SUITE 1CITY:FLORHAM PARKSTATE:NJZIP:07932

8-K1v381986_8k.htm8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM8-K

CURRENT REPORT
PURSUANT TO SECTION13 OR 15(d)OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported):June 23, 2014

PROTALEX, INC.

(Exact Name of Registrant as Specified inCharter)

DELAWARE 000-28385 91-2003490

(State or Other Jurisdiction
of Incorporation) (Commission File Number) (I.R.S. Employer
Identification No.)

131 Columbia Turnpike, Suite 1

Florham Park, NJ 07932

07932

(Address of Principal Executive Offices) (Zip Code)

(215) 862-9720

(Registrants telephone number, includingarea code)

N/A

(Former name or former address, if changedsince last report)

Check the appropriate box below if the Form8-K filingis intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

o Written communications pursuant to Rule425 under the Securities Act of 1933, as amended (17 CFR 230.425)

o Soliciting material pursuant to Rule14a-12 under the Securities Exchange Act of 1934, as amended (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule14d-2(b)under the Securities Exchange Act of 1934, as amended (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule13e-4(c)under the Securities Exchange Act of 1934, as amended (17 CFR 240.13e-4(c))

Item 8.01.Other Events.

On June 23, 2014, Protalex, Inc. will beattending the BIO International Convention, being held June 23 - 26, 2014 at San Diego, California, at which it may utilize thepresentation attached as Exhibit 99.1 hereto.

Item 9.01.Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Protalex, Inc. BIO International Convention presentation

******

SIGNATURES

Pursuant to the requirements of the SecuritiesExchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

PROTALEX, INC.

Dated: June 23, 2014 By: /s/ Arnold P. Kling

Arnold P. Kling

President

EX-99.12v381986_ex99-1.htmEX-99.1

June, 2014

Forward - Looking Statement Statements made in this presentation stating the Company s beliefs, intentions, and expectations are forward - looking statements. The company s actual results could differ materially from those projected. Additional information is contained in the company s SEC filings such as our Form 10 - K and Form 10 - Qs filed at www.sec.gov . 2 Protalex , Inc .

Protalex , Inc. Biotechnology company focused on autoimmune diseases Public company, ticker is PRTX, market capitalization approximately $250 mm Lead product: PRTX - 100 Staphylococcal protein A, a natural protein isolated from cultured bacteria Safe and well - tolerated in four human clinical trials Efficient and inexpensive production process 3 Protalex , Inc.

Protalex Key Team Members Arnold P Kling President, Director; Principal of Niobe Ventures, LLC, experienced investor in and manager of early stage technology companies Kirk M Warshaw CFO, Director; experienced in finances of development stage company James W Dowe III Vice - Chair of SAB; active investor in biotechnology, computer software and investment management companies William E. Gannon, MD Chief Medical Officer; more than 20 years experience in clinical development and regulatory affairs at Quintiles, PPD, and other companies; Medical Director for Capital City Technical Consulting Bruce McClain, MD Medical Director; more than 20 years experience in clinical development and product safety; senior roles at Aeras Global and MedImmune Richard Frankovich , Ph.D . -- VP of ITP Programs; 27 years pharma experience, former Head of Hematology Franchise and Global Commercial Leader for Promacta at GSK Benjamin R Bowen, Ph.D . Senior Advisor; background in pharma and biotech R&D, investment banking Michelle Catalina, Ph.D . Director of Preclinical Studies; academic research background in immunology, former instructor at U Mass Medical Center 4

PRTX - 100 Background Highly purified Staphylococcus aureus protein A (SPA) SPA is a superantigen SPA acts as an immunological disguise and increases bacterial virulence Purified SPA binds antibodies, forming discrete immune complexes, and immune cells of monocyte lineage, attenuating their inflammatory activity ( MacClellan , et al. 2011) Demonstrated activity in cellular and animal models of disease 5 Protalex , Inc.

Animal Studies of PRTX - 100 PRTX - 100 reduces footpad swelling in the murine CIA model of arthritis PRTX - 100 inhibits platelet phagocytosis by human macrophages in vitro model for ITP, an orphan disease PRTX - 100 is not immunosuppressive like anti - TNFs Pretreat w drug Challenge w Candida albicans Anti - TNF potentiates infection 6 0 20 40 60 80 100 -1 1 2 3 4 5 6 7 8 9 PERCENT SURVIVAL STUDY DAY Vehicle Etanercept PRTX 50 PRTX 250 anti-TNF

Autoimmune Disease Market Opportunity RA biologics current market value exceeds $18 B and is growing RA market disruptions envisioned PFEs Xeljanz ( tofacitinib ) oral drug recently approved Biosimilars to anti - TNFs and anti - CD20s in development Current biologics are expensive to produce and have limited use outside of US, Europe, and Japan; our cost per treatment is thousands - fold less, enabling a global strategy Other autoimmune diseases represent highly underserved indications with potential for orphan drug designation 7 Protalex , Inc .

PRTX - 100 Clinical Experience 2005 IND filed for RA 2006 Phase 1 study completed 2007 Second Phase 1 using PRTX - 100 with improved production/CMC processes 2010 - 11 Phase 1b Study (PRTX - 100 - 103) in South Africa; presented at ACR Annual Meeting in November, 2012 November 2012 Second Phase 1b Study (PRTX - 100 - 104 ), initiated in US June 2014 Topline results of unblinded analysis of cohorts 1 through 4 of PRTX - 100 - 104 8 Protalex , Inc.

PRTX - 100 - 103: Study Objectives Primary Assess safety and tolerability of iv PRTX - 100 weekly x 4 doses Secondary Assess immunogenicity after 3 doses Determine PK and estimate of PRTX - 100 plasma exposure after first and fourth dose Determine whether a relationship exists between immunogenicity of PRTX - 100 and safety and PK Assess effect of PRTX - 100 on measures of disease activity, e.g., DAS28 - CRP and CDAI 9 Protalex , Inc.

PRTX - 100 - 103: DAS28 < 3.2 0 5 10 15 20 25 30 PRTX-100 Placebo % of patients with DAS28 < 3.2 at 6 and 10 weeks Day 42 Day 70 3/29 6/29 0/8 0/8 10 Protalex , Inc.

PRTX - 100 - 103: Summary PRTX - 100 was well tolerated 3 mild to moderate infusion reactions, no SAEs related to study drug Anti - PRTX - 100 antibodies elicited in majority of patients but neither incidence nor titer was related to dose Patients with antibody response showed increased clearance without increase in AEs. Antibodies do not appear to preclude treatment response Relationship between dose and C max was linear but clearance and AUC were variable The higher doses of PRTX - 100 resulted in low disease activity, with maximal improvement at 10 weeks after the first dose 11 Protalex , Inc.

PRTX - 100 - 104 : Overview Multi - center US study initiated 4Q12. Phase 1b randomized, multiple - dose, placebo - controlled, dose - escalation study of PRTX - 100 in adults with active RA on MTX 41 patients dosed in four dose - escalating cohorts, starting at 1.50 m g/kg, with fifth cohort to investigate extended dosing schedule Primary objective: safety and tolerability of PRTX - 100 administered by iv injections over five weeks Secondary objectives include determining effects on measures of disease activity, assessing immunogenicity, evaluating PK, and investigating durability of response Enrollment commenced November 2012 in the US; last dose of cohorts one through four completed July 2013; expansion cohorts completed September 2013; cohort 5 initiated October 2013, last dose expected August 2014, topline cohort 5 data 4Q14 Topline data for cohorts 1 through 4 announced June 3, 2014 12 Protalex , Inc .

PRTX - 100 - 104: Study Design Patients with RA: 4 swollen and 5 tender joints (28 joint count) Positive RF or anti - CCP Stable dose of MTX or leflunomide Treatment Randomized in blocks (3:1) PRTX - 100 at 1.5, 3.0, 6.0, or 12.0 g/kg iv, five weekly doses Measurements PK at 1 st and 4 th doses; antibodies at day 1, 22, 57 and EOS; safety at screening and day 15, 29, 57, and EOS; CBCs at 1, 2, 15, 22, 29, 57, 85, 113, and EOS; components of ACR20/50/70 and DAS28CRP at screening, day 1, 8, 15, 22, 29, 57, 85, 113, and EOS 13

PRTX - 100 - 104: Patient Demographics 14 PRTX - 100 dose 1.5 g/kg 3.0 g/kg 6.0 g/kg 12 g/kg All Placebo No. of patients a 6 9 9 5 29 8 Mean age, years (SD) 61.2 (13.3) 57.6 (11.8) 63.3 (9.7) 62.6 (6.8) 61.1 (10.3) 59.9 (9.4) Age range, years 47 76 30 72 42 71 51 72 30 72 46 71 Male, % 66.7 44.4 33.3 57.1 48.4 30 Caucasian, % 83.3 88.9 77.8 85.7 83.9 80.0 Weight, kg (SD) 74.6 (4.3) 91.4 (20.6) 81.0 (16.2) 86.0 (16.9) 83.9 (16.9) 82.3 (14.0) Day 1 DAS28 - CRP (SD) 4.9 (0.55) 5.3 (0.62) 4.8 (0.67) 4.65 (0.88) 4.93 (0.68) 5.30 (0.87) Day 1 DAS28 swollen joint count (SD) 10.2 (4.54) 13.0 (6.4) 8.9 (4.23) 13.6 (5.18) 11.2 (5.32) 12.8 (5.50) Day 1 CDAI (SD) 37.9 (10.7) 44.7 (12.4) 34.7 (11.3) 37.6 (14.0) 39.0 (12.1) 43.6 (13.2) Day 1 CRP (SD) 0.86 (1.02) 0.29 (0.24) 0.25 (0.18) 0.69 (1.01) 0.49 (0.69) 0.74 (0.66) RA disease duration, years (SD) 10.0 (2.93) 15.9 (11.7) 15.6 (11.1) 8.1 (3.9) 13.0 (9.7) 8.4 (6.8)

PRTX - 100 - 104: Overall safety Doses of 1.5 to 12 g/kg PRTX - 100 appeared well - tolerated and demonstrated no dose - limiting toxicities. No treatment - related SAEs and no requirement for expedited reports to FDA Most commonly reported AEs were fatigue and flare of RA symptoms of mild to moderate severity No laboratory abnormalities associated with PRTX - 100 except transient lymphopenia 24 hours post - dose 37 of 41 randomized patients completed day 85; 2 of 31 PRTX - 100 - treated and 2 of 10 placebo - treated patients withdrew because of AEs. 15

PRTX - 100 - 104: Promising Effects on Measures of Disease Activity Results are not inconsistent with therapeutic activity PRTX - 100 - treated patients had a higher categorical response rate for ACR, CDAI, and DAS28 - CRP at days 29, 57, 85, and 113 vs placebo 43% of PRTX - 100 treated patients achieved DAS28 - CRP < 3.2 (mean pretreatment DAS28 - CRP was 4.93) Other promising trends with categorical analyses 16

PRTX - 100 - 104: RA Disease Activity 17 PRTX - 100 dose Disease activity endpoint, a % of patients 1.5 g/kg (n=6) 3.0 g/kg (n=9) 6.0 g/kg (n=9) 12.0 g/kg (n=5) All (n=29) Placebo ( n =8) ACR20 CRP day 29 33.3 33.3 22.2 40.0 31.0 12.5 ACR20 CRP day 57 50.0 50.0 33.3 80 50.0 37.5 ACR20 CRP day 85 33.3 33.3 66.7 48.3 48.3 42.9 ACR50 CRP day 29 16.7 11.1 11.1 20 13.8 0 ACR50 CRP day 57 33.3 37.5 22.2 40 32.1 12.5 ACR50 CRP day 85 16.7 22.2 25.0 20 21.4 14.3 ACR70 CRP day 57 16.7 12.5 11.1 0 10.7 0 DAS28 - CRP 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