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CritiTech PES partner NanOlogy Announces Initiation of a Lung Cancer Clinical Trial Following FDA Allowances of Two IND Applications for NanoPac® in Lung Cancer

  • First-in-human clinical trial of intratumoral (IT) injections of NanoPac in non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) is expected to begin enrollment in August
  • The clinical trial follows FDA allowance of IT NanoPac in neoplasms of the lung
  • FDA also allowed a second IND for nebulized inhalation of NanoPac in NSCLC

FT. WORTH, (June 9, 2020) — NanOlogy, LLC, a clinical-stage oncology company, announced today initiation of a clinical trial of IT NanoPac® (submicron particle paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in NSCLC and SCLC. The trial follows FDA allowance of an investigational new drug (IND) application for IT NanoPac in neoplasms of the lung. A second IND was also allowed by FDA for a nebulized inhaled form of NanoPac in NSCLC. Five INDs have been established for NanoPac allowing progress of clinical trials via multiple routes of targeted administration for a variety of solid tumors including pancreatic, prostate, ovarian, peritoneal, and now lung.

Clinical Trial of NanoPac in Lung Cancer
The first study to proceed will be a Phase 2a dose-rising and expansion trial (NCT04314895) evaluating the safety and tolerability of up to 3 monthly IT injections of NanoPac delivered via EBUS-TBNI, concurrent with standard of care therapy, in patients with primary or recurrent NSCLC or SCLC. In addition to safety and pharmacokinetics (PK), the study will measure progression free survival, overall survival, and tumor response determined from CT scan imaging. Blood and biopsy samples will be evaluated for immune effect through flow cytometry and multiplex immunohistochemistry analysis. The trial will begin at two clinical sites: Parkview Healthcare Institute in Fort Wayne, Indiana and University of Florida Health Cancer Center in Gainesville, Florida. More clinical sites will follow. The first subject is expected to be enrolled in August 2020.

Preclinically, a nebulized inhaled form of NanoPac was retained in lung tissue for more than 14 days in a PK model and caused tumor regression and immune cell infiltration in an orthotopic model of NSCLC. Clinical plans for inhaled NanoPac are under development.

Other Clinical Experience with Targeted Delivery of NanoPac
To date, approximately 70 patients have received targeted injections of NanoPac across clinical trials in the prostate and pancreas. Another 30 patients have received intraperitoneal NanoPac for peritoneal and ovarian cancers. NanoPac has been well tolerated in these study subjects with no confirmed drug-related serious adverse events reported. Along with safety and tolerability, signs of activity have also been observed across the clinical programs.

NanOlogy Submicron Particle Therapeutic Platform
The NanOlogy submicron particle therapeutic platform is based on a proprietary production technology that converts taxane API crystals into stable submicron particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (US 10,507,195) both valid until 2036 in the US and pending globally. In addition to lung cancer, NanOlogy clinical programs are advancing in pancreatic, genitourinary, peritoneal, ovarian, and dermal cancers.

About Lung Cancer
In 2020, an estimated 228,820 new cases of lung cancer will be diagnosed in the U.S. and 135,720 people will die from the disease. Lung cancer is by far the leading cause of cancer deaths in the U.S. responsible last year for 22% of all cancer-related deaths (SEER). Globally, lung cancer is also the most common form of cancer and the deadliest accounting for an estimated 2.1 million annual new cases and 1.8 million deaths (GLOBOCAN 2018).

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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 targeted, sustained delivery of proven drugs aimed at increasing their value in the treatment of cancer and other serious diseases.

Disclaimers
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 as required by U.S. FDA and have not been approved for commercial distribution. NanOlogy and NanoPac are trademarks of NanOlogy LLC.

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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.

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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. 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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CritiTech PES partner 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

April 09, 2019 05:30 AM Eastern Daylight Time

FT. WORTH, Texas–(BUSINESS WIRE)–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).

In 2019, an estimated 80,000 new cases of bladder cancer will be diagnosed in the United States and an estimated 18,000 will die from the disease. Despite being one of the top five cancer diagnoses in the U.S., the last drug FDA approved for NMIBC was more than a decade ago. Of all cancers, bladder cancer tends to have the highest lifetime treatment costs due to the frequency of recurrence, progression to MIBC often requiring removal of the bladder (cystectomy), and lifetime cost of care thereafter.

In the NanOlogy clinical trial, following transurethral resection of the bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with an intravesical instillation of NanoDoce. Additional intravesical instillations of NanoDoce will be administered to NMIBC subjects while MIBC subjects will follow institutional standard of care.

The local delivery of submicron particle docetaxel suspension [NanoDoce] represents an important step in evaluating new therapies for the treatment bladder cancer”, said Dr. Donald Lamm, MD, President of BCG Oncology and principal investigator on the trial. “Preclinical studies suggest the submicron particle technology improves both the penetration of drug into the bladder wall and its duration of activity. If this investigational drug can be proven to delay or prevent disease progression and need for cystectomy, it would contribute significantly to the quality of life of patients with this disease.”

An abstract from preclinical studies of NanoDoce was presented in February at the 2019 Genitourinary Cancer Symposium. In one of the studies, NanoDoce administered via intratumoral injection resulted in prolonged, high concentration of drug in tumor tissue, significant tumor regression, and immune cell infiltration in a xenograft animal model of transitional cell bladder carcinoma. The immune cell infiltration is of particular interest to NanOlogy for future research into the role NanoDoce may play in combination with immunoncology therapy for the treatment of advanced disease.

This work is in addition to extensive preclinical and clinical development programs underway by NanOlogy in peritoneal/ovarian cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, renal cell carcinoma, non-small cell lung 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 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.

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.

Disclaimers

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.

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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NanOlogy Takes Nanoparticle Tech into Phase II Trials

OCTOBER 16, 2017 BY SARAH FAULKNER

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.

The Texas-based company’s nanoparticle tech is based on a production process that cuts the size of chemotherapy crystals by up to 400 times, creating stable nanoparticles with increased surface area and unique geometry, NanOlogy explained. The particles do not require coating agents for stability and are suspended prior to use.

NanOlogy’s dose-rising Phase IIa prostate cancer trial is slated to enroll up to 30 patients who are scheduled for a prostatectomy. Four weeks before their scheduled procedures, patients will receive the company’s NanoPac injected under transrectal ultrasound guidance directly into the tumor site. The company said it plans to assess NanoPac’s safety and tolerability, as well as tumor size change, local lymph nodes and histologic changes.

The company’s Phase II ovarian cancer study is designed to evaluate NanoPac’s safety and efficacy after being intraperitoneally administered following cytoreductive surgery.

NanOlogy is conducting an array of clinical trials for the NanoPac sterile suspension, including studies in pancreatic cancer and pancreatic mucinous cysts. The company is awaiting IND approval to launch a clinical trial for NanoDoce, a nanoparticle formulation of docetaxel.

The company is also running a preclinical efficacy study for an inhaled version of NanoPac. Pharmacokinetic studies have shown that lung tissues retain the inhaled nanoparticles for more than 14 days after nebulized delivery.