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 October 2016

 

Prana Biotechnology Limited

(Name of Registrant)

 

Level 2, 369 Royal Parade Parkville  Victoria  3052 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.	New data from Reach2HD trial presented at American Neurological Association Annual Meeting

 

 

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

  

October 18, 2016

 

 

 

 

New data from Reach2HD trial presented at American Neurological Association Annual Meeting 

 

MELBOURNE, Tuesday October 18^th, 2016: Prana Biotechnology Ltd (ASX PBT: NASDAQ PRAN) is pleased to announce that further analysis of the cognitive results of its Reach2HD trial to treat Huntington Disease was presented in a poster¹ at the American Neurological Association (ANA) Annual Meeting in Baltimore, United States.

Previously it has been reported that executive function as measured by the Trail Making Test Part B (TMTB) was significantly improved in the Reach2HD trial². Moreover, as previously announced at the Movement Disorders conference at Berlin this year³, of those patients in Reach2HD that reported cognitive improvement using the Huntington Disease Patient-Reported Outcome of Problems, or ‘HD-PROP’ assessment, 90% had received Prana PBT2 treatment.

 

This new analysis being reported today was undertaken to further explore the verbatim patient-reported outcomes captured by the HD-PROP by applied Natural Language Processing (NLP). The poster titled Applying Natural Language Processing (NLP) to Verbatim Patient Reported Outcomes explores natural language processing and memory activity of patients enrolled in the Reach2HD clinical trial and was presented by Professor Ira Shoulson and Dr Karen Anderson and research colleagues at the at Georgetown MedStar University (Washington DC).

 

Using NLP methods to extract relationships and meaning from large text-based resources, such as the HD-PROP verbatim data, word clouds (images composed of words from a text where the size of the word indicates frequency or importance) were derived from the HD-PROP data in the Reach2HD trial at baseline and week 26. The Reach2HD NLP data showed a decrease in “memory” complaints at week 26 in the PBT2 250mg treatment compared with placebo. This improvement in cognitive function using the NLP computer based examination of the patient reported data, supports the positive cognition findings with PBT2 to date from both the HD-PROP assessment and the TMTB rating scale.

 

Dr Karen Anderson, study principal investigator stated: “The study shows the potential of listening to subjects’ own reports about how a treatment impacts them, rather than relying only on clinician ratings.”

 

¹ ANA Abstract Submission NLP 4.8.16 and NLP Poster

 

² Huntington Study Group Reach2HD Investigators (2015). Safety, tolerability, and efficacy of PBT2 in Huntington's disease: a Phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol.14(1):39-47. Published Online November 14, 2014 http://dx.doi.org/10.1016/S1474-4422(14)70262-5

 

³ 20^th Annual International Movement Disorder Society Congress, Berlin 22 June, 2016

 

 

 

 

Contacts:
Investor Relations	Media
Rebecca Wilson	Scott Newstead
E: rwilson@buchanwe.com.au	E: snewstead@buchanwe.com.au
Tp: +61 3 9866 4722	Tp: +61 3 9866 4722

 

About Prana Biotechnology Limited

Prana Biotechnology was established to commercialise research into Alzheimer's disease, Huntington disease and other major age-related neurodegenerative disorders. The Company was incorporated in 1997 and listed on the Australian Stock Exchange in March 2000 and listed on NASDAQ in September 2002. Researchers at prominent international institutions including The University of Melbourne, The Mental Health Research Institute (Melbourne) and Massachusetts General Hospital, a teaching hospital of Harvard Medical School, contributed to the discovery of Prana’s technology.

 

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, PBT2, 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, PBT2, 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, PBT2, 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 PBT2, 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.