On February 5, 2018 NanOlogy, a clinical stage pharmaceutical development company, reported that Gere diZerega, MD, VP of Medical Affairs, will present at BIO CEO & Investor Conference, February 12, 2018, at 3:15 PM EST in the Brecht room of the New York Marriott Marquis (Press release, NanOlogy, FEB 5, 2018, View Source [SID1234523737]).
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Dr. diZerega will share promising preliminary data from the NanOlogy clinical development programs. The company is developing a submicron particle technology platform for local delivery of chemotherapeutic agents for the treatment of cancer and related illnesses via intratumoral, intracystic, intraperitoneal, and topical administration.
"The NanOlogy submicron particle platform may provide more effective therapies for multiple indications either as early first line treatments or in combination regimens," said lead scientific advisor Maurie Markman, MD, President of Medicine and Science, Cancer Treatment Centers of America. "Early trial results indicate that the platform may enable local delivery of large, sustained amounts of the drug at the site of disease, thereby reducing systemic exposure and systemic side effects."
Clinical Programs
NanOlogy has four Phase 2 clinical trials underway for NanoPac, a sterile suspension of submicron particle paclitaxel, in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. NanOlogy also is conducting a Phase 2 trial of SOR007, submicron particle paclitaxel suspended in a topical anhydrous base, for cutaneous metastases, while NanOlogy affiliate, DFB Soria, has a Phase 2 trial of SOR007 nearing completion for actinic keratosis. In 2018, a clinical trial is planned in bladder cancer for NanoDoce, a sterile suspension of the submicron particle docetaxel, pending IND approval.
Preclinical
In addition, NanoPac for nebulized inhalation has shown tumor reduction in a preclinical lung cancer study after pharmacokinetic studies demonstrated an unprecedented 14-day retention of drug in lung tissue with no gross or histologic abnormalities in the tissue.
Patent Portfolio
The NanOlogy submicron particle technology platform is protected by an extensive intellectual property (IP) portfolio covering production processes, uses, formulations, and specifications, as well as composition under US patent 9,814,685 entitled Taxane Particles and Their Use valid until June 2036 covering particle size, density, surface area, drug dissolution, and other aspects. NanOlogy investigational drugs are being developed under FDA’s streamlined 505(b)2 pathway. Coupled with the composition patent, and expanding IP portfolio, the company enjoys NME (new molecular entity) – like advantages without the corresponding risk and timeline.
NanOlogy expects results from its clinical trials in 2018 and during this time will be exploring options to progress its drug candidates to NDA submission, market approval, and commercial distribution.