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CritiTech Particle Engineering Solutions Launches New Pharmaceutical Spray Drying Business

FOR IMMEDIATE RELEASE
May 30, 2018

LAWRENCE, KS – CritiTech Particle Engineering Solutions, a growing Contract Development Manufacturing Organization (CDMO) and expert in particle engineering, announced today the launch of its new pharmaceutical spray drying business.  The company provides spray drying services to enhance the bioavailability of poorly soluble drugs (BSC II and IV), and to design and manufacture a variety of API’s and excipients.

CritiTech Particle Engineering Solutions offers spray drying services from proof-of-concept to cGMP production for a wide array of compounds, including non-potent compounds to those with an OEL down to 0.03mg/m3 (Safebridge Category 3 compounds), using organic solvents or water.  It can spray dry material from milligrams to hundreds of kilograms.  The company is licensed to handle substances classified by the U.S. Drug Enforcement Administration as Schedule II-V.

In addition to its spray drying services, CritiTech Particle Engineering Solutions also provides extensive on-site particle characterization and analytical services.  All services are supported by an in-house quality assurance and quality control team.

The investment made in the spray drying business builds on the company’s capabilities to engineer drug particles with its proprietary Supercritical Precipitation Technology, which is used to improve the bioavailability, efficacy, pharmacokinetics, dosing, delivery and toxicity of poorly soluble drugs.  CritiTech Particle Engineering Solutions has worked with over 80 drugs using its Supercritical Precipitation Technology and developed four drug products that are currently being tested in six Phase II Trials.

“CT PES is committed to providing a best-in-class CDMO experience to each and every one of its customers. Our goal is to create personal, productive, long-term, business relationships that create significant value for our clients,” said Matthew McClorey, President.  “Combining spray drying with our Supercritical Precipitation Technology strengthens our particle engineering capabilities and enables us to better serve our customers’ particle engineering needs.”

Responses from CritiTech Particle Engineering Solutions’ initial spray drying customers have been positive.  For example, upon completion of their project, a multi-billion-dollar spray drying client remarked, “Thank you for the wonderful work you have done on this project.  Your skills and work ethic are exemplary and unique.  We look forward to continuing to work with your company.”

CritiTech Particle Engineering Solutions will expand its CDMO business and add new capabilities and staff as customer demand grows.

About CritiTech Particle Engineering Solutions

CritiTech Particle Engineering Solutions (CT PES) is an established, growing, pharmaceutical Contract Development Manufacturing Organization (CDMO) with extensive experience and expertise in particle engineering, material characterization, analytical testing, early stage drug development, pre-clinical and clinical manufacturing.  The company utilizes Spray Drying and Supercritical Precipitation to help its customers develop their drugs.  CT PES uses proprietary Supercritical Precipitation Technology and Spray Drying to help its customers improve and optimize the bioavailability of poorly soluble drugs.  It also uses these technologies to engineer a wide range of pharmaceutical drugs to improve their efficacy, pharmacokinetics, dosing, delivery and toxicity.  CT PES’ clients include three “Top 15” pharma companies.

Contact:

Matthew McClorey
President
785-841-7120
mmcclorey@crititech.com

For more information about CritiTech, please visit www.crititech.com.

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NanOlogy to Unveil Positive Preclinical Data for Inhaled NanoPac® in Treatment of Lung Cancer at 2018 ASCO Annual Meeting

Update – 6/4/18:  Link to NanOlogy Poster presented at 2018 ASCO Annual Meeting

  • Studies of Inhaled NanoPac Show Prolonged Retention in the Lung, Decreased Primitive Tumor cells, and Increased Tumor Regression

FT. WORTH/DALLAS, (May 29, 2018) BUSINESS WIRE — NanOlogy LLC, a clinical-stage pharmaceutical development company, will present data from preclinical studies of inhaled NanoPac (submicron particle paclitaxel) showing prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations in an orthotopic animal model of non-small cell lung cancer (NSCLC).

The data will be presented in an abstract entitled “NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model” during the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, June 3rd, from 8:00 AM to 11:30 AM in Hall A of McCormick Place in Chicago.

An initial preclinical pharmacokinetic (PK) study examined the retention of NanoPac in rat lung tissue following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue.

A preclinical study followed to examine the therapeutic effect of inhaled NanoPac using an orthotopic model of NSCLC. Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression.

Gere diZerega, MD, VP of Medical Affairs, said, “In our initial PK study, inhaled NanoPac resulted in longer lung retention of drug at a higher concentration compared to systemically administered paclitaxel. The evidence seen in our preclinical PK and efficacy studies has given us the confidence to move forward with IND-enabling studies in preparation for clinical trials.”

Lung cancer is by far the leading cause of cancer death according to the American Cancer Society with more than 154,000 deaths expected this year. More people die of lung cancer every year than breast, prostate, and colon cancers combined.

The preclinical lung cancer studies are in addition to an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce® (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

NanOlogy is also progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.

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About NanOlogy

NanOlogy, LLC (www.nanology.us) is a clinical stage pharmaceutical company formed by DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

Media Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com 
404-245-0591