AndhraNews.net
Home » Business News » 2015 » November » November 10, 2015

New Colombia Resources to Apply for an Orphan Drug Designation With the FDA for a Medical Marijuana Pharmaceutical Drug to Treat a Rare Pediatric Disease


November 10, 2015 - Sunny Isles Beach, Fl And Cali, Colombia

New Colombia Resources, Inc.(OTC PINK: NEWC) ("New Colombia" or the "Company"), a U.S. company with specialty metallurgical coal, medical marijuana, and hemp assets, is pleased to announce they are partnering with Advanced Imaging Projects (AiP) on the development, clinical trials, and accelerated regulatory agency approvals of a cannabinoid for multiple medical indications with a focus on treatment of a rare pediatric disease. The company and its partner are studying several indications to apply for. Once the application is submitted the designation is expected within a few months. Cannabinoid pharmaceuticals are expected to be a multi-billion dollar industry.

Advanced Imaging Projects (AiP) is a clinical stage specialty biopharmaceutical company based in South Florida that develops molecular medicines for diagnosis and treatment of oncological, neurological, and infectious diseases. They are committed to providing drugs that can enhance patient outcomes and improve quality-of-life. "AiP received several million dollars in peer reviewed competitive research grants and similarly, could anticipate support for this project from the U.S. National Institute of Health, which may also be a potential collaborator," stated Dr. Stanley Satz, PhD., Chairman and Chief Scientific Officer of Advanced Imaging Partners. "There would be great personal satisfaction in this project as I lived in Colombia for 5 years while working for the World Health Organization there," further commented Dr. Satz.

Various orphan drug designations were applied for and received by AiP from the U.S. Food and Drug Administration (FDA) for tuberculosis, pediatric neuroblastoma, Moyamoya disease and multiple system atrophy, a Parkinsonian movement disorder. These designations confer significant advantages including waiver of application filing fees, expedited approval, government grants, and reduced number of patients in clinical trials. Dr. Satz stated, "My sense is that by working together with New Colombia Resources, similarly we could obtain this for the cannabinoid under development."

Last year only three orphan drug designations were approved for rare pediatric disease, AiP received one of them. Visit http://www.orphan-drugs.org/2014/11/04/fda-orphan-drug-designations-october-2014/. Last week AiP received an approval for another orphan drug designation as well.

Dr. Satz has developed and obtained U.S. Food and Drug Administration approval for Strontium Chloride Sr89, an injectable therapeutic radiopharmaceutical for treatment of prostate and breast cancer metastatic bone pain (See Strontium or Bio-Nucleonics in the FDA Orange Book). The drug is also approved by INVIMA, Colombia's equivalent of the FDA. "After meeting with Stan, I'm convinced he is the right partner for our FDA application, doing the clinical trials in Colombia in collaboration with Universities and Government agencies will greatly reduce the costs of clinical trials," stated John Campo, Chairman and President of New Colombia Resources.

New Colombia Resources and AiP are building a team of physicians, biostatisticians, and toxicologists in preparedness of FDA trials and a pre- IND meeting.

Additionally, Sannabis began their first workshop at a major university in Colombia to set up protocols for accredited courses in Agronomic and Agro Industrial Engineering for hemp production and medical marijuana studies. Students and faculty are very interested in exploring this new industry. The next workshop will be December 4th. The first hemp crops are scheduled to be planted in January at the University. More specific details will follow in the coming weeks.

To view or purchase Sannabis products visit www.sannabis.co. Follow Sannabis on Facebook for photos and testimonials at https://www.facebook.com/sannabis.cannamedicinal

New Colombia Resources, Inc.

New Colombia Resources, Inc. is focused on the acquisition and development of high-quality metallurgical coal properties and other available resources in the Republic of Colombia. They expect to have several revenue producing businesses including; metallurgical coal mining and rock quarry aggregates for domestic Colombian highway and railroad building projects. The Company owns 100% of La Tabaquera metallurgical coal mine in Colombia with an estimated 15- 17 million tonnes of reserves. They have another pending acquisition for 390 ha and a solicitation contract for 184 ha metallurgical coal concession. New Colombia Resources also holds a significant position in Sannabis SAS which legally produces medical marijuana products in the Republic of Colombia, visit www.sannabis.co. For more information on the Company visit www.newcolombiaresources.com.

Forward Looking Statements

Forward Looking Statements; This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing works such as "anticipate," "seek," intend," "believe," "plan," "estimate," "expect," "project," "plan," or similar phrases may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements might not occur. Factors that could cause or contribute to such differences include financing, the future U.S. and global economies, the impact of competition, and the Company's reliance on existing regulations. New Colombia Resources, Inc. does not undertake any duty nor does it intend to update the results of these forward-looking statements.

Contact:
Company Contact:
New Colombia Resources, Inc.
John Campo
President/Chairman
(1)-410-236-8200 USA
jcampo@newcolombiaresources.com
info@newcolombiaresources.com

MarketWire

Comment on this story

Share