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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.

The preclinical PK study examined the retention of NanoPac in rat lung 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. The 14-day retention of drug in lung tissue came as a surprise to researchers who had never seen this length of retention before.

A follow-on preclinical study examined the therapeutic effect of inhaled NanoPac using an orthotopic model of non-small cell lung cancer (NSCLC). Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression. Data from this study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting this past June in an abstract entitled “NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model”. Immunohistochemistry stains of NanoPac treated animals demonstrated immune cell infiltration that suggested immune-mediated tumor kill in addition to a direct tumoricidal effect.

IND-enabling studies are underway on NanoPac to allow for a clinical trial in 2019. This work is in addition to an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, bladder cancer, renal cancer, breast cancer, and 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 new molecular entity-like advantages without the risks and timeline associated with NME drug development.

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About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 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 Contact

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

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

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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.

Actinic Keratosis affects 58 million Americans and is caused by exposure to the sun and other sources of UV radiation. The condition is responsible for 8 million visits to dermatologists or primary care physicians in the US annually. Left untreated, AK can progress to squamous cell carcinoma (SCC), the second most common form of skin cancer. Each year, more than one million people are diagnosed with SCC and as many as 9,000 people die from the disease. IV Paclitaxel is approved by FDA for the treatment of advanced SCC, which provided Soria the rationale for developing its topical product for AK.

“The most widely prescribed topical treatment for AK contains 5-fluorouracil, which causes severe dermal irritation and significantly decreases quality of life for several weeks during use,” said Gere diZerega, MD, VP of Medical Affairs. “Our goal was to demonstrate our product would result in AK lesion reduction without the severe irritation that limits other topical products. We now may identify a pharma partner or proceed ourselves as the results from this trial allow us to move forward with a dose confirmation trial followed by a pivotal phase 3 trial if successful.”

The submicron particle paclitaxel contained in the Soria product is produced by a proprietary production technology that reduces the size of unprocessed paclitaxel API crystals up to 400 times into stable, uncoated particles of pure drug with exponentially increased surface area and unique geometry. The particles are so unique they have been granted a composition of matter patent (US 9,814,685) that is valid until 2036. This provides the product new molecular entity-like IP advantages with a streamlined 505(b)2 FDA regulatory pathway.

NanOlogy, LLC, a company related to Soria, is also underway on a phase1/2 clinical trial of a similar topical product for the treatment of cutaneous metastases, which is expected to complete in early 2019. Cutaneous metastases are skin lesions secondary to certain metastatic cancers and represents an unmet medical need because no approved topical treatments exist for common forms of the condition.

The company is evaluating options for bringing both products to regulatory approval including sale or license to a dermatology-focused company or continued internal investment.

NanOlogy has an exclusive license for the submicron particle production technology with investigational drugs currently in clinical trials for peritoneal malignancies (with orphan drug status), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, clinical trials are planned by NanOlogy in bladder cancer in late 2018 and in lung cancer and renal cancer in 2019.

About Soria and NanOlogy

DFB Soria, LLC (www.dfbsoria.com) is owned and operated by DFB Pharmaceuticals LLC. Soria developed its submicron particle paclitaxel anhydrous ointment under an exclusive worldwide license from CritiTech, Inc. for dermatology. NanOlogy, LLCis a private clinical stage pharmaceutical company formed in 2015 to finance and clinically develop the submicron particle technology platform for local, sustained delivery of chemotherapeutic agents 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 and Soria 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 U.S. 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 print

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CritiTech PES partner 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.

The new sites for the pancreatic cancer trial are Parkview Regional Medical Center in Fort Wayne, IN with Neil Sharma, MD serving as principal investigator (PI) and Texas Tech University Health Sciences Center in El Paso with Antonio Mendoza-Ladd, MD the PI. Parkview will also be a new site for the Phase 2 MCN trial with Dr. Sharma serving as PI.

Parkview and Texas Tech join two other sites for the pancreatic cancer trial: Baylor St. Luke’s Medical Center in Houston, TX and Cedars-Sinai Medical Center in Los Angeles. The PIs for the Baylor and Cedars-Sinai sites are Mohamed Othman, MD and Simon Lo, MD, respectively.

In addition to Parkview, the other sites for the Phase 2 MCN trial are Baylor St. Luke’s Medical Center with Dr. Othman as the PI and University of Chicago Medical Center with Irving Waxman, MD, serving as PI.

To date, the independent Data and Safety Monitoring Boards for both trials have found no drug-related safety concerns and both studies have dose-escalated in accordance with their clinical protocols.

NanoPac is part of a broad submicron particle technology platform developed by NanOlogy. The technology reduces paclitaxel crystals to submicron particles for direct injection into the pancreatic cancer tumors and MCNs. The particles are so unique in terms of size and surface area that they have recently been granted a composition of matter patent valid until 2036.

Intratumoral injection of NanoPac, rather than systemic infusion of paclitaxel, enables local delivery of a more concentrated dose at the site of disease that kills pancreatic cancer cells over a longer period without adverse systemic side effects.

If successful in clinical trials, intracystic delivery of a high, locally sustained concentration of NanoPac for patients with high risk MCN’s could serve as an alternative to surgery, which is the primary treatment.

An estimated 55,000 new cases of pancreatic cancer will be diagnosed in 2018 and 44,000 people will die from the disease. Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the US with a survival rate of only 25% at one year and less than 10% at five years.

Pancreatic cysts affect an estimated 3 million Americans, and most are benign. However, a subset of pancreatic cysts called MCN’s are deemed to be at high risk for progression to pancreatic cancer and prevalence estimates range from 60,000 to 180,000 people.

The Phase 2 trials in pancreatic cancer and pancreatic mucinous cysts are part of an extensive clinical development program underway by NanOlogy. Local administration of NanoPac also is being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation) and prostate cancer. A clinical trial of NanoDoce (submicron particle docetaxel sterile suspension) is planned to begin in in late 2018 for bladder cancer and in 2019 for renal cancer.

In addition, NanOlogy is progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases. An inhaled version of NanoPac in preclinical lung cancer studies demonstrated prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations. The positive findings will be used to support an IND to begin clinical trials of inhaled NanoPac for treatment of non-small cell lung cancer.

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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 regarding our product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and NanOlogy disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven safe and effective in accordance with the requirements of the FDCA and are not 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

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

  • Intratumoral injection of three concentrations of NanoPac successfully completed across a total of 9 patients
  • Highest concentration of NanoPac continues into dose confirmation phase of trial as no drug-related local or systemic side effects observed
  • Histologic examination of prostate tissue shows tumor regression

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.

The Phase 2a trial is enrolling patients with local prostate cancer scheduled for prostatectomy. In the trial, patients receive intratumoral injection of NanoPac 28 days before surgery. Tumor volume and prostate tissue biopsy taken prior to NanoPac administration is compared to tumor volume and tissue after surgery.

In the dose escalation phase to determine highest concentration of drug which can be safely administered, 6 mg/mL, 10 mg/mL, 15 mg/mL concentrations of NanoPac were each injected into three patient cohorts followed by safety review for each cohort. No drug related serious adverse events were reported in any of the cohorts and preliminary data show evidence of tumor reduction and tumor cell death.

“NanoPac is injected directly into the cancerous lobe of the prostate under MRI/TRUS fusion guidance”, said Andre Abreu, MD, Assistant Professor of Clinical Urology, Co-director of Image-Guided Surgery & Focal Therapy of Prostate and Kidney Cancer at the University of Southern California’s Institute of Urology. “The drug injected locally has been well tolerated to date and we have progressed into the dose confirmation phase of the trial to further assess safety and tumor response.”

“NanoPac is injected directly into the cancerous lobe of the prostate under MRI/TRUS fusion guidance”, said Andre Abreu, MD, Assistant Professor of Clinical Urology, Co-director of Image-Guided Surgery & Focal Therapy of Prostate and Kidney Cancer at the University of Southern California’s Institute of Urology. “The drug injected locally has been well tolerated to date and we have progressed into the dose confirmation phase of the trial to further assess safety and tumor response.”

The dose confirmation phase has begun and will enroll 9 additional patients for a total of 18 patients who received direct injection of NanoPac 28 days prior to their scheduled prostatectomy. In addition to assessing safety and tolerability, tumor size and histologic evidence of tumor response will be evaluated, and local lymph nodes will be analyzed to investigate potential lymphatic transport of NanoPac. Completion of the clinical trial and final report are expected in the third quarter of 2018.

Prostate cancer affects an estimated 3 million men in the US with about 160,000 new cases and 27,000 deaths annually. Patients at higher risk for disease progression or those in whom the cancer has spread may face surgical removal of the prostate or radiation therapy. Unfortunately, these patients often suffer incontinence or impotence, which significantly decrease quality of life.

Dr. Abreu added, “If we are successful, we may offer a treatment option for moderate or high-risk patients with localized or non-metastatic disease potentially providing better oncologic outcomes while minimizing side-effects of chemotherapy, and therefore maintaining quality of life.”

The prostate cancer study is part of 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), pancreatic cancer, and pancreatic mucinous cysts.

An inhaled version of NanoPac for lung cancer has demonstrated prolonged lung tissue residence time and tumor regression in preclinical studies and a clinical trial of NanoDoce® (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

In addition, NanOlogy is progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases. The topical product was developed by NanOlogy affiliate DFB Soria, who has also recently completed a Phase 2 clinical trial of the product in actinic keratosis, which showed lesion reduction and no drug-related local or systemic adverse events.

All the NanOlogy and Soria products 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, naked submicron particles of pure drug with exponentially increased surface area and unique geometry. The particles are so unique they have recently been granted a composition of matter patent (US 9,814,685) which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.

###

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. DFB disclaims any intent or obligation to update these statements. NanOlogy and Soria 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

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Presentation

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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Presentation

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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Presentation

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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Presentation

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.