NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

NanOlogy may offer an alternative treatment option for patients with bladder cancer

Investigational drug, NanoDoce, is injected locally into tumor resection bed via cystoscope guidance followed by intravesical instillation

FT. WORTH, Texas (April 9, 2019) —NanOlogy, a clinical-stage oncology company, today announced the first patient has been enrolled in a clinical trial of NanoDoce (sterile submicron particle docetaxel suspension) for treatment of bladder cancer. The Phase 1/2 dose-rising trial will evaluate the safety and preliminary efficacy of NanoDoce for patients with high-risk non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC).

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Positive Preclinical Findings from Inhaled NanoPac® Lung Study Published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery

Preclinical Study Demonstrated Inhaled NanoPac Shows Prolonged Retention and Limited Systemic Exposure

FORT WORTH/DALLAS, (October 30, 2018) — NanOlogy, a clinical-stage oncology development company, announced today that positive findings from a pharmacokinetic (PK) preclinical study of inhaled NanoPac (submicron particle paclitaxel for nebulized inhalation) was published in an article entitled “Pharmacokinetic Profile of Inhaled Submicron Particle Paclitaxel (NanoPac) in a Rodent Model,” in the Journal of Aerosol Medicine and Pulmonary Drug Delivery.

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DFB Soria Completes a Phase 2 Clinical Trial of Submicron Particle Paclitaxel Anhydrous Ointment for Actinic Keratosis

Soria investigational drug provides evidence of actinic keratosis (AK) lesion reduction without the local irritation of approved topical AK treatment products

FT.WORTH, Texas & DALLAS– DFB Soria, a DFB Pharmaceuticals company, today announced completion of a dose-rising clinical trial of a topically applied submicron particle paclitaxel suspended in a pharmaceutically elegant, preservative-free anhydrous base. The trial was designed to evaluate safety and preliminary efficacy of four strengths of the product applied twice daily for 28 days. Results from the trial show evidence of AK lesion reduction in size and count, dose response, and minimal local irritation or other side effects.

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NanOlogy Adds Clinical Trial Sites for Phase 2 Clinical Trials of NanoPac® in Pancreatic Cancer and Pancreatic Mucinous Cysts

Preliminary Data from Both Trials Show NanoPac Well-Tolerated via Intratumoral and Intracystic Injection

FORT WORTH/DALLAS, (August 8, 2018) — NanOlogy LLC, a clinical-stage pharmaceutical development company, today announced the opening of three new sites for its Phase 2 clinical trials of NanoPac (submicron particle paclitaxel) sterile suspension in the treatment of pancreatic adenocarcinoma and mucinous cystic neoplasms (MCNs) of the pancreas.

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NanOlogy™ Completes Dose Escalation Portion of Phase 2 Clinical Trial of NanoPac® for Treatment of Prostate Cancer

FT.WORTH/DALLAS, (April 30, 2018) — NanOlogy LLC, a clinical-stage pharmaceutical development company, has completed the dose escalation phase of an open-label clinical trial of NanoPac (submicron particle paclitaxel sterile suspension) injected directly into the tumor area for treatment of prostate cancer. Successful completion of the dose escalation phase has allowed the highest concentration of NanoPac to begin the dose confirmation phase of the trial, which will continue to generate data on safety and tumor response.

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NanoPac® Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model

Background: NanoPac® is patented submicron particle paclitaxel in stable powder form without coating or carrier agents. In a previous PK study, healthy male rats inhaled a single exposure of nebulized NanoPac® (0.37 mg/kg or 1.0 mg/kg) or IV Abraxane® (5.0 mg/kg) with a final necropsy time-point at 14
days. T1/2 of NanoPac® and Abraxane were 56hrs and 20hrs with drug present at 14 days and not after 3 days, respectively. Tissue examined from the last time point were microscopically indistinguishable from non-treated controls.

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Targeted Delivery of Submicron Particle Cancer Chemotherapy: Helping Shift the Immunotherapy Paradigm

NanOlogy™, a clinical-stage pharmaceutical development company, was formed in 2015 to increase the effectiveness and safety of CT through targeted delivery. Based on a proprietary submicron particle production technology, the company has developed stable, uncoated submicron particles of the taxanes, paclitaxel and docetaxel, as investigational drugs, which can be administered directly to the site of disease via injection, instillation, or inhalation.

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Pharmacokinetic Profile of Inhaled Submicron Particle Paclitaxel (NanoPac) in a Rodent Model

Inhaled chemotherapeutics may enhance pulmonary drug exposure to malignant lesions in the lung without substantially contributing to systemic toxicities. The pharmacokinetic profile of inhaled submicron particle paclitaxel (NanoPac) in healthy rodent plasma and lung tissue is evaluated here to determine administration proof-of-principle.

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Evaluation of Submicron Particle Docetaxel Directly Injected into Uro-Oncologic Xenografts

Suspensions of submicron particle taxanes (Figure 1) allow for direct administration of high, sustained levels of chemotherapeutics at the site of disease. Intratumoral (IT) injections of submicron particles of pure docetaxel (NanoDoce) into clear cell renal carcinoma (786-O), transitional cell bladder carcinoma (UM-UC-3) and prostate carcinoma (PC-3) xenografts were evaluated.

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NanOlogy Named to BioSpace Top 20 Life Science Startups to Watch in 2019

BioSpace is proud to present its NextGen Bio “Class of 2019,” a list of 20 up-and-coming life science companies in North America that launched* no earlier than 2017.

The NextGen Bio Class of 2019 is a stellar group of companies that are already making an enormous impact on the industry now and will continue into the future. Congratulations to this group!

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Targeted Delivery of Submicron Particle Cancer Chemotherapy: Helping Shift the Immunotherapy Paradigm

Chemotherapy (CT) has been used in the treatment of cancer since the late 1940s.  A new class of chemotherapeutic agents called taxanes were introduced in the 1990s and remains on of the key advances in the fight against cancer.

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Wuxi AppTec: Small Molecule Chemotherapy May Play a Big Role in Cancer Immunotherapy

The combination of chemotherapies and immunotherapies highlights the significance of small molecule drug development as an ongoing treatment modality. Although there has been an explosion in immunotherapy development, small molecules continue to dominate the treatment of cancers, and recent research reveals that chemotherapies, such as taxanes, benefit immunotherapies.

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CritiTech Particle Engineering Solutions Launches New Pharmaceutical Spray Drying Business

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.

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

FT. WORTH/DALLAS, (May 16, 2018) — 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).

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New Cancer Answer

FORT WORTH, Texas—Researchers have been trying to develop therapeutic agents powerful enough to destroy tumors without harmful effects to healthy cells for a long time. NanOlogy is working toward this goal by trying to transform systemic chemotherapy into local delivery of naked nanoparticles to treat various forms of cancer with greater efficacy and safety.

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NanOlogy takes nanoparticle tech into Phase II trials

NanOlogy

In the last two weeks, NanOlogy has launched trials evaluating its cancer-fighting paclitaxel nanoparticle suspension in patients with prostate cancer and in patients with ovarian cancer.

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DFB Pharmaceuticals, CritiTech, and US Biotest Form NanOlogy™ for Clinical Development of Naked Nanoparticle Platform to Treat Cancer and Related Illnesses

Systemic chemotherapy transformed into local delivery with potential for greater efficacy and safety to treat cancer and other serious illnesses

FORT WORTH, Texas, Sep 12, 2017 (BUSINESS WIRE) — DFB Pharmaceuticals, a private investment and development group, in collaboration with CritiTech and US Biotest, has formed NanOlogy to finance and develop a breakthrough technology platform to produce unique, patented, naked nanoparticle forms of paclitaxel and docetaxel for local delivery with the potential for greater efficacy and safety to treat cancer and other serious illnesses.

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