NEWS,NEWS,NEWS MR.BUFFETT CHECK IT OUT Sunshine Biopharma Negotiating With CRO's to Initiate Master Drug File for Adva-27a Anticancer Compound
Marketwired Sunshine Biopharma Inc. 11 minutes ago
MONTREAL, QC--(Marketwired - Sep 3, 2014) - Sunshine Biopharma Inc. (OTCQB: SBFM), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it is currently negotiating with several Contract Research Organizations (CRO's) with the intent to engage one of them for the purposes of initiating, compiling and managing a regulatory master drug file for Adva-27a, the Company's flagship anticancer compound. A master drug file contains all of the information that regulatory agencies require as part of the drug development and approval process. Such information includes preclinical data, GMP manufacturing process, large animal studies and human trials.
"Engaging a CRO is the next step in our Adva-27a drug development program," said Dr. Steve N. Slilaty, CEO of Sunshine Biopharma. "We are delighted to have arrived at this advanced stage in the development of our Adva-27a. The CRO will compile the testing results conducted to date, follow and document the GMP manufacturing process, manage the large animal studies and file with the appropriate regulatory agencies for go-ahead with Phase I human trials."
About Adva-27a
Adva-27a is Sunshine Biopharma's lead anticancer compound, a small molecule that has recently been shown to be effective at killing Multidrug Resistant Breast Cancer cells, Small-Cell Lung Cancer cells, Uterine Sarcoma cells and Pancreatic Cancer cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Adva-27a is currently in the IND-Enabling stage of development. The original U.S. patent covering Adva-27a was issued on August 7, 2012 under U.S. patent number 8,236,935. The Company is planning a Phase I clinical trial of Adva-27a for Pancreatic Cancer in parallel to the Phase I clinical trial of Adva-27a for multidrug resistant Breast Cancer to be conducted at McGill University's Jewish General Hospital in Montreal (Canada).
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.
Contact:
For Additional Information
Camille Sebaaly
CFO
Sunshine Biopharma Inc.
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
www.sunshinebiopharma.com
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