0001144204-18-037599.txt : 20180709 0001144204-18-037599.hdr.sgml : 20180709 20180709060952 ACCESSION NUMBER: 0001144204-18-037599 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20180709 FILED AS OF DATE: 20180709 DATE AS OF CHANGE: 20180709 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PRANA BIOTECHNOLOGY LTD CENTRAL INDEX KEY: 0001131343 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-49843 FILM NUMBER: 18943324 BUSINESS ADDRESS: STREET 1: P.O. BOX 655 CITY: CARLTON, SOUTH VIC STATE: C3 ZIP: 3053 BUSINESS PHONE: 61-0-9824-5254 MAIL ADDRESS: STREET 1: P.O. BOX 655 CITY: CARLTON, SOUTH VIC STATE: C3 ZIP: 3053 6-K 1 tv498176_6k.htm 6-K

 

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

  

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR

15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of July 2018

 

Prana Biotechnology Limited

(Name of Registrant)

 

Level 3, 460 Bourke Street, Melbourne, VIC 3000, Australia.

(Address of Principal Executive Office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x                   Form 40-F ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): __

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): __

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes ¨                      No x 

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _____

 

This Form 6-K is being incorporated by reference into the Registrant’s Registration Statements on Form F-3 (File No. 333-199783) and Form S-8 (File No. 333-153669). 

 

 

 

 

 

PRANA BIOTECHNOLOGY LIMITED

 

6-K Items

 

1.

Prana to present PBT434 data at International Congress

 

 

 

 

SIGNATURES

 

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

  

  PRANA BIOTECHNOLOGY LIMITED
    (Registrant)
     
     
  By: /s/ Geoffrey Kempler   
    Geoffrey Kempler,
    Executive Chairman

  

July 9, 2018

 

 

EX-99.1 2 tv498176_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

PBT434 data to be presented at the International Congress of Parkinson’s Disease and Movement Disorders

 

Prana’s PBT434 prevents neuronal loss in a new model of neurodegeneration

 

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – July 9th 2018: Prana Biotechnology Ltd (ASX PBT: NASDAQ PRAN) has today announced it will be presenting further pre-clinical evidence for PBT434 at the International Congress of Parkinson’s Disease and Movement Disorders® to be held in Hong Kong from October 5-9, 2018.

 

The data to be presented will include new in-vivo evidence of the efficacy of PBT434 to prevent neuron loss and improve function in an animal model of Multiple system atrophy (MSA), an important cause of atypical Parkinsonism.  MSA is a rapidly progressive and devastating neurological disease with no established treatments and is one of the target indications for PBT434.

 

PBT434 is the first of a new generation of small molecules designed to inhibit the aggregation of alpha(α)-synuclein and tau, vital intracellular proteins that are implicated in neurodegenerative diseases such as Parkinson’s disease and atypical Parkinsonism. PBT434 has been shown to reduce the abnormal accumulation of these proteins in animal models of disease by restoring normal iron balance in the brain. Prior non-clinical characterization of PBT434, including animal models of Parkinson’s disease, was published last year in Acta Neuropathologica Communications and may be found at https://doi.org/10.1186/s40478-017-0456-2.

 

The experimental data to be presented demonstrate that in an animal model of MSA, PBT434 prevents α-synuclein accumulation, preserves neurons, and decreases the number of glial cell inclusions in the brains of treated animals.  Glial cell inclusions are the key pathological finding in MSA and contain abundant aggregated α-synuclein that is associated with neurodegeneration.  Importantly, these benefits led to improved motor function in treated animals.  Alpha-synuclein is of great interest because aggregated forms of the protein are considered a pathological hallmark of Parkinsonian conditions and are a recognised therapeutic target by basic and clinical neuroscientists. 

 

“Multiple system atrophy, or MSA, is a devastating orphan disease with limited treatment options. These animal data are robust and indicate that PBT434 has excellent potential to help individuals with MSA. Having recently started our first human study of PBT434, these data represent an important step as we pursue new treatments for Parkinsonian diseases”, said David Stamler, Chief Medical Officer and Senior Vice President of Clinical Development.

 

The initial human study of PBT434 commenced in June 2018.

 

Page 1 of 2

 

 

 

 

The International Congress of Parkinson’s Disease and Movement Disorders® is the preeminent scientific meeting for sharing ideas and stimulating interest in the care and research of movement disorders, and is organized annually by the International Parkinson and Movement Disorder Society.

 


Contacts:

 

Investor Relations Media
Ben Walsh Scott Newstead
E: bwalsh@we-buchan.com E: snewstead@we-buchan.com
Tp: +61 422 520 012 Tp: +61 3 9866 4722

 

For further information please visit the Company’s web site at www.pranabio.com.

 

Forward Looking Statements

 

This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, PBT434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, PBT434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, PBT434, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, the intellectual property relating to PBT434, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.

 

Page 2 of 2

 

GRAPHIC 3 image_001.jpg GRAPHIC begin 644 image_001.jpg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