This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.

Start Date01 Aug 2014

Sponsor / Collaborator

Sumitomo Pharma America, Inc.

NCT01770353

/ CompletedPhase 1

A Phase I Study in Patients Treated With MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.

Start Date01 Nov 2012

Sponsor / Collaborator

Ipsen SA

EUCTR2011-004687-30-CZ

/ Not yet recruitingNot Applicable

NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398, with or without 5-Fluorouracil and Leucovorin, versus 5-Fluorouracil andLeucovorin, in Patients with Metastatic Pancreatic Cancer Who have Failed Prior Gemcitabine-based Therapy - NAPOLI 1

Start Date12 Apr 2012

Sponsor / Collaborator

Merrimack Pharmaceuticals, Inc.

100 Clinical Results associated with Irinotecan Sucrosofate Liposome

100 Translational Medicine associated with Irinotecan Sucrosofate Liposome

100 Patents (Medical) associated with Irinotecan Sucrosofate Liposome

Literatures (Medical) associated with Irinotecan Sucrosofate Liposome

01 Jun 2025·Current pharmaceutical biotechnology

Nanotheranostics: A Cutting-edge Technology for Cancer Management

Article

Author: Swain, Shasank Sekhar ; Dash, Shwetapadma ; Sahoo, Sanjeeb Kumar ; Dutta, Sneha ; Khuntia, Auromira

Cancer is the second-leading cause of death in the 21st century, where early detection and appropriate therapeutic interventions are two components essential for effective cancer management. Despite the availability of several conventional diagnostics and therapeutic agents, cancer mortality rates are rising due to an increase in the frequency of recurrence and metastasis in cancer patients. Therefore, tremendous efforts have been expended to address this significant clinical issue and improve therapeutic efficacy. In this regard, nanotheranostic is a multipotential single platform for both cancer diagnosis and treatment through enhanced aqueous solubility and bioavailability of the encapsulated agent, stimulus responsiveness, tumor-specific targeting ability, precise tumor imaging, and real-time drug delivery. Nonetheless, the translational success of nanotheranostic platforms is still in its infancy and requires more extensive research in the context of tumor heterogeneity, safety profile, and regulatory issues, which pose one of the largest technological limitations. The present review summarizes different nanotheranostic platforms and nanotheranostic candidates in clinical trials (AGuIX® , NBTXR3, Ferumoxtran, MM-398, EndoTAG-1, etc.), along with disadvantages and challenges to improving cancer diagnosis and treatment. Overall, the concept, platform, and technical knowledge of nanotheranostics are really helpful to academic and pharmaceutical researchers.

26 Dec 2022·Journal of biomolecular structure & dynamics

Probing intermolecular interactions and binding stability of antimicrobial peptides with beta-lactamase of Klebsiella aerogenes by comparing FDA approved beta-lactam drugs: a docking and molecular dynamics approach

Article

Author: Chakkyarath, Vijina ; Natarajan, Jeyakumar

Hospital pathogens, including Klebsiella aerogenes are becoming increasingly common, with the rise of Beta-lactam-resistant strains, especially in isolates recovered from intensive care rooms. Beta-lactamases participate in both the antibacterial activity and the mediation of the antibiotic resistance of Beta-lactams. The rapid spread of broad-spectrum Beta-lactam antibiotic resistance in pathogenic bacteria has recently become a major global health problem. As a result, new drugs that specifically target Beta-lactamases are urgently needed, and this enzyme has been identified to resolve the problem of bacterial resistance. In previous work, we de-novo developed, synthesized, and studied the in-vitro and in-silico behavior of four novel broad spectrum antimicrobial peptides, namely PEP01 to PEP04. All four peptides had significant antibacterial action against K. aerogenes. The literature evidence strongly suggests that Beta-lactamases are extremely important for bacteria, including K. aerogenes, and hence are therapeutically important and possible targets. Therefore, in this study we incorporated molecular modeling, docking, and simulation studies of the above four AMPs against the Beta-lactamase protein of K. aerogenes. The docking findings were also compared to eight FDA approved Beta-lactam antibiotics. According to our findings, all four peptides have strong binding affinity and interactions with Beta-lactamases and PEP02 has the highest docking score. In MD simulations, the protein-peptide complexes were more stable at 50 ns. We found that the new AMP-PEP02 is the most efficient and suitable drug candidate for inactivating Beta-lactamase protein, and that it is an alternative to or complements existing antibiotics for managing Beta-lactamase related resistance mechanisms based on this computational conclusion.Communicated by Ramaswamy H. Sarma.

01 Dec 2016·BMC cancerQ2 · MEDICINE

A phase I dose-escalation study of PEP02 (irinotecan liposome injection) in combination with 5-fluorouracil and leucovorin in advanced solid tumors

Q2 · MEDICINE

ArticleOA

Author: Yeh, C Grace ; Wang, Yi-Wen ; Chen, Li-Tzong ; Hsieh, Ruey-Kuen ; Wang, Cheng-Hsu ; Chao, Tsu-Yi ; Chiang, Nai-Jung

BACKGROUND:

PEP02 (also known as MM-398, nal-IRI) is a novel nanoparticle formulation of irinotecan encapsulated in liposomes. The aims of this study were to investigate the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics (PK) of PEP02 in combination with 5-FU and LV, in patients with advanced refractory solid tumors.

METHODS:

Patients were enrolled in cohorts to receive PEP02 from 60 to 120 mg/m² (dose expressed as the irinotecan hydrochloride trihydrate salt) as a 90-min intravenous infusion on day 1, followed by 24 h infusion of 5-FU 2,000 mg/m² and LV 200 mg/m² on days 1 and 8, every 3 weeks.

RESULTS:

A total of 16 patients were assigned to four dose levels, 60 (three patients), 80 (six patients), 100 (five patients) and 120 mg/m² (two patients). DLT was observed in four patients, two at the 100 mg/m² dose level (one had grade III infection with hypotension and grade III hemorrhage; the other had grade III diarrhea and grade IV neutropenia), and two at the 120 mg/m² dose level (one had grade III diarrhea and grade IV neutropenia; the other had grade III diarrhea). The MTD of PEP02 was determined as 80 mg/m². The most common treatment-related adverse events were nausea (81%), diarrhea (75%) and vomiting (69%). Among the six patients who received the MTD, one patient exhibited partial response, four patients had stable disease and one showed progressive disease. Pharmacokinetic data showed that PEP02 had a lower peak plasma concentration, longer half-life, and increased area under the plasma concentration-time curve from zero to time t of SN-38 than irinotecan at similar dose level.

CONCLUSIONS:

The MTD of PEP02 on day 1 in combination with 24-h infusion of 5-FU and LV on days 1 and 8, every 3 weeks was 80 mg/m², which will be the recommended dose for future studies.

TRIAL REGISTRATION:

The trial was retrospectively registered ( NCT02884128 ) with date of registration: August 12, 2016.

News (Medical) associated with Irinotecan Sucrosofate Liposome

22 Aug 2018

·www.biospace.com

A Glimpse into the Pancreatic Cancer Pipeline

According to the National Cancer Institute (NCI), pancreatic cancer is relatively rare, with about 55,440 cases diagnosed annually, representing about 3.2 percent of new cancer cases. But each year, 44,330 Americans die from the disease, or about 7.3 percent of cancer deaths. The passing of renowned singer Aretha Franklin has focused attention on pancreatic cancer. Franklin, 76, succumbed to a neuroendocrine tumor of the pancreas. According to the National Cancer Institute (NCI) , about 55,440 cases of pancreatic cancer are diagnosed annually, representing about 3.2 percent of new cancer cases. But each year, 44,330 Americans die from the disease, or about 7.3 percent of cancer deaths. It is now the third-leading cause of cancer death in the United States. And it’s a tough cancer to beat, with only 8.5 percent surviving for five years. One problem is, like cancer itself, pancreatic cancer is not a single disease. Anirban Maitra, scientific director of the Sheikh Ahmed Pancreatic Cancer Research Center at the University of Texas MD Anderson Cancer Center , told Forbes, “The first thing to do if somebody gets a diagnosis of pancreatic cancer is to know what they are dealing with. Because everything they deal with will change dramatically based on that.” Forbes points out that neuroendocrine tumors, the type that Aretha Franklin had, as did Apple founder Steve Jobs , are the rarer type of pancreatic cancer. Forbes writes, “Afinitor, a drug made by Novartis , has been shown to help patients whose neuroendocrine tumors have spread outside the pancreas, increasing the time before their tumors grow by six months, to 11.5 months. In a clinical trial, patients who got Afinitor did not live longer than those who received placebo; this may be because the study allowed patients in the placebo group to get the drug once their tumors start to grow.” For patients with the more common form of pancreatic cancer, adenocarcinoma, the prognosis is worse. Famous people who died from adenocarcinoma include Dirty Dancing actor Patrick Swayze and opera singer Luciano Pavarotti. For these types, there are typically two chemotherapy regimens, one a combination of Gemzar and Abraxane, and the other a mixture of drugs called FOLFIRINOX. They extend survival from about four months to nine months in the average patient. Maitra points out that surgical removal when the tumor is small gives the best odds of survival. If one problem is the type of cancer, early detection is another. Pancreatic cancer is one of those types of cancer that is typically diagnosed from symptom s —abdominal pain, jaundice, weight loss, for example, in many cases. And by that time, the cancer has often spread, and surgery is not an option. Diagnosis is performed using a CT scan or an invasive procedure, such as a needle biopsy and invasive ultrasound. In March 2018, OncLive discussed pancreatic cancer drugs currently in the pipeline with Tanios Bekaii-Saab, professor of medicine at Mayo Clinic . He noted, “Over the last few years, we have developed new strategies to extend survival for our patients. Half of the patients are crossing the one-year survival line, with 25 percent crossing the two-year survival line. We have patients who survive, three, four, and five years, but it is less than 5 percent of patients. However, this would be unheard of five or six years ago, so we are doing better. We are on the right path to ultimately bring pancreatic cancer into the mainstream.” He notes there are two primary pathways for treating pancreatic cancer. The first is gemcitabine and Abraxane (nab-paclitaxel). When that fails, they receive 5-fluorouracil (5-FU) and MM-398 (irinotecan liposomem injection; Onivyde) based on the NAPOLI-1 trial. For the third-line setting, they try a platinum-based approach, such as FOLFOX or cisplatin. Bekaii-Saab notes that genetic understanding of the disease is improving, and along with that understanding, some successes with new therapies have been seen. “For patients with microsatellite instability-high (MSI-H) tumors, immunotherapy works best. That subgroup was included in the study that led to the approval of pembrolizumab (Keytruda) in MSI-H cancers. There were a few patients with pancreatic cancer who had incredible responses. One patient continues to be in a complete remission from that treatment.” That’s a rare subset of pancreatic cancers. Another group has BRCA1/2 and PALB2 mutations and homologous recombination deficiency (HRD). Bekaii-Saab says that platinum-based treatment and PARP inhibitors are showing promise for treating these subgroups. “The three PARP inhibitors that have been studied the most are veliparib, olaparib, and rucaparib. Veliparib appears to be the least potent. There are rare reports of any single-agent activity of this drug in pancreatic cancer…. The other two PARP inhibitors, olaparib and rucaparib, have shown single-agent activity in refractory patients. I don’t believe that single-agent PARP inhibitors are going to be the answer for an aggressive disease like pancreatic cancer, but they would be optimally combined for maintenance phases.” He believes that combining these drugs with irinotecan-based compounds and then a liposomal irinotecan or platinum-based drug might be a good approach. There are also at least two other approaches and drugs that show promise, Bekaii-Saab says. “The first is PEGPH20, which is an agent that targets the stroma and hyaluronan (HA). It breaks down that stroma to allow chemotherapy into the tumor to maximize the kill. It is a great concept and looks very promising.” PEGPH20 is being developed by Halozyme Therapeutics . And finally, Bekaii-Saab brings up napabucasin (BBI-608), a stem cell inhibitor under development by Boston Biomedical . “Napabucasin seems to inhibit and facilitate killing lowering the chemosensitizing capacity against these pancreatic cancer cells. If you give it with chemotherapy and gemcitabine, nab-paclitaxel, or paclitaxel, you seem to kill those cancer cells more efficiently and prevent them from reverting to the stemless phenotype.” As frustratingly slow as treatments for this rare cancer may be, there are signs of progress.

Immunotherapy

12 Jan 2016

·www.biospace.com

Baxalta’s CEO Hantson to Leave After Merger With Shire is Complete

January 12, 2016 By Alex Keown , BioSpace.com Breaking News Staff BANNOCKBURN Ill. – One day after agreeing to a merger proposal by Dublin-based Shire , the first of the big management changes at Baxalta was announced. Ludwig Hantson , chief executive officer of Illinois-based Baxalta , will leave the company when the merger is finalized, the Chicago Tribune reported Tuesday afternoon. The roles of other Baxalta executives have not yet been made public. Citing an employee FAQ posted with the U.S. Securities and Exchange Commission , the Tribune said the roles of the other executives “will be determined through the integration process.” The merger is expected to be completed in mid-2016. Hantson has helmed Baxalta for six months, since Baxalta spun out of the biosciences division of Baxter International . Before becoming CEO of Baxalta , Hantson served as president of Baxter ’s bioscience divisions. In July, Baxalta Incorporated , a pharmaceutical spinout of Baxter launched with hopes of fielding 20 new products by 2020. The company broke away from Baxter with a value of $6 billion and a robust portfolio that will help the company meet that 2020 goal. In March 2014, Baxter announced plans to spin out two separate, independent companies, Baxalta and another company focused on medical products and will remain under the Baxter logo. Since its spinoff, Shire Pharmaceuticals has been going back and forth with Baxalta in an attempt to acquire the company. Nine days after Baxalta launched, Shire approached the company with a stock-only deal worth almost $31 billion. In early August, Shire went public with the offer in hopes of pressuring the Baxalta board and shareholders into considering the deal. After six months, the Baxalta board agreed to the deal , which is valued at about $32 billion. The merger of Shire and Baxalta will create a pharmaceutical company with one of the largest rare disease platforms. The pipeline will include Baxalta ’s hematology drug, Adynovate, Antihemophilic Factor (Recombinant), PEGylated, to treat hemophilia A, and Hyqvia, a next-generation subcutaneous immunoglobulin (IG) product to treat patients with primary immunodeficiency. Shire’s top drug is Vyvanse, for the treatment of attention deficit hyperactivity disorder (ADHA) and for moderate-to-severe Binge Eating Disorder. Another rare disease drug in Shire ’s arsenal is Cinryze for the treatment of hereditary angioedema, which is expected to generate $765 million. In October, Cinryze received Fast Track Designation from the U.S. Food and Drug Administration intravenous administration in subjects with Antibody Mediated Rejection in renal transplant recipients. The combined company will also possess a growing franchise in Oncology, with approved products and innovative compounds in development, as well as a robust late-stage Ophthalmics pipeline. To bolster the oncology pipeline, in May, before the July launch of Baxalta , Baxter International plunked down $900 million to acquire Oncapar, a promising leukemia treatment from Italian company Sigma-Tau Finanziaria S.p.A. Baxalta entered into partnership with Merrimack Pharmaceuticals Inc. to support Merrimack ’s New Drug Application for MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas. The drug was granted priority review status by the U.S. Food and Drug Administration (FDA) and is also under review by the European Medicines Agency (EMA) . Shire ’s stock hit a daily high of $181.71 per share, up about 6.8 percent for the day. Baxalta ’s stock hit a high of $40.40 per share.

Executive ChangeFast TrackAcquisitionPriority Review

24 Sep 2015

·www.biospace.com

Three Cancer Drugs are Up for FDA Approval in October

September 24, 2015 By Mark Terry , BioSpace.com Breaking News Staff Analysts are keeping an eye on what drugs are up for approval. Three potential cancer drugs will have decisions made in October, reports The Motley Fool. Merck’s Keytruda Kenilworth, N.J.-based Merck & Co. ’s Keytruda is one of a particular hot type of cancer treatment these days, targeting PD-1, a programmed death 1 receptor. The PD-1/PD-L1 pathway has been identified in cancer as important in helping tumors dodge the body’s immune system. Keytruda has shown a lot of promise for treating a variety of cancers. In March 2015, Merck announced it had halted its pivotal Phase III KEYNOTE-006 clinical trial because it met its two primary endpoints early. That study analyzed KEYTRUDA for the treatment of advanced melanoma, and the drug showed statistically significant and “clinically meaningful improvement in overall survival and progression-free survival compared to ipilimumab.” The U.S. Food and Drug Administration (FDA) is scheduled to decide on Oct. 2, 2015, whether to expand Keytruda’s label to include patients suffering from non-small cell lung cancer (NSCLC). In April, the company presented trial results at a meeting of the American Association for Cancer Research, showing the drug’s successes in treating melanoma, lung cancer and mesothelioma. In its study of the drug in NSCLC, the company found 45 percent of patients with high levels of PD-L1 showed positive responses to Keytruda compared to 16.5 percent of patients with PD-L1 levels between 1 to 49 percent. “The results from this study formed the basis for our Breakthrough Therapy designation and our recent FDA submission for advanced NSCLC, and indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to Keytruda in this tumor type,” said Roger Perlmutter, president of Merck Research Laboratories in a statement. Merrimack Pharmaceuticals’ MM-398 The FDA is to make a decision on Oct. 24 of Merrimack ’s MM-398 for pancreatic cancer. Merrimack, based in Cambridge, Mass., announced on June 25 that the FDA had accepted the company’s New Drug Application (NDA). The company is hoping for approval for the drug for treatment of metastatic adenocarcinoma of the pancreas in patients who have previously been treated with gemcitabine-based therapy. The FDA also granted the NDA Priority Review status. The drug hit its primary and secondary endpoints of statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group in its Phase III NAPOLI-1 study. The drug is also being reviewed by the European Medicines Agency (EMA) for a Marketing Authorization Application (MAA) for the same indications. The company hopes the drug might be able to replace irinotecan in the FOLFIRI regimen. Irinotecan is marketed as Camptosar by Pfizer and Campto by Yakult Honsha. FOLFIRI is a regimen of cancer treatment that includes folinic acid (leucovorin), fluorouracil (5-FU), and irinotecan. Amgen’s T-Vec Thousand Oaks, Calif.-based Amgen has been in the news a lot lately. On Friday the FDA accepted the company’s supplemental New Drug Application (sDNA) for Kyprolis (carfilzomib) for Injection for patients with relapsed myeloma. It also recently received approval for Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone in relapsed multiple myeloma. On Sept. 16, the company announced it was acquiring Naarden, Netherlands-based Dezima Pharma B.V., that focuses on cholesterol medications. Yesterday the company announced , along with Dublin, Ireland-based Allergan plc (AGN), positive results for a Phase III study on non-squamous cell lung cancer for the drug ABP 215 compared to Avastin (bevacizumab) in adults. The company’s T-Vec (talimogen laherparepvec) is up for approval from the FDA on Oct. 27. T-Vec is a herpes simplex virus that has been reengineered to replicate inside cancer cells, which will eventually destroy the tumor cells from the inside. It is being evaluated as a treatment for advanced melanoma. The Motley Fool points out that this drug’s approval isn’t quite as promising or clear as some of its other drugs. In Phase III studies, the drug met its primary endpoint of durable response in advanced melanoma patients, but did not show statistically significant improvement in median overall survival, which was a key secondary endpoint. In April, 22 of the 23 members of an FDA panel voted in approval. Nonetheless, the panel expressed some concern over the study design. Amgen acquired the rights to the drug in 2011 from Biovex for $425 million and an additional $575 million in potential milestone payments. Other companies have drugs in this space, including Bristol-Myers Squibb Company (BMY)’s Yervoy (ipilimumab) and Opdivo (nivolumab), and Merck’s Keytruda. Will the Presidential Election Change the Face of the Way Prescription Drugs are Sold in the United States? Although Turing Pharmaceuticals announced it will revise its 5,000 percent increase of a newly acquired drug to treat toxoplasmosis, the move sparked a public outcry that resulted in one presidential candidate calling for price caps on prescription medication. In August, Turing Pharmaceuticals acquired toxoplasmosis drug Daraprim from Impax Laboratories and increased the price of the medication from $13.50 per tablet to $750 per tablet, a 5,000 percent increase. Turing Chief Executive Officer Martin Shkreli defended the increase, saying the revenues would be used to subsidize new research into treatments for toxoplasmosis. Has since said the company will reduce the price, but did not specify what the price would be. Democratic presidential candidate Hillary Clinton said if elected she would cap monthly out-of-pocket costs for prescription drugs at $250 to avoid “price gouging.” Her comment sent the stock market into a state of flux, with several large companies seeing a drop in their stock of up to 10 percent. The Nasdaq Biotechnology Index dropped 4.4 percent and the SPDR S&P Biotech ETF dropped by 6 percent. BioSpace wants to know what you think: Will the presidential election change the face of the way prescription drugs are sold in the United States? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-presidential-election-change-face-of-way-prescription-drugs-are-sold-in-us", placeholder: "pd_1443026823" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' 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Phase 3Clinical ResultBreakthrough TherapyPriority ReviewNDA

100 Deals associated with Irinotecan Sucrosofate Liposome

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Cancer	Phase 3	United States	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Argentina	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Australia	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Brazil	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Canada	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Czechia	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	France	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Germany	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Hungary	Merrimack Pharmaceuticals, Inc.	01 Nov 2011
Metastatic Pancreatic Cancer	Phase 3	Italy	Merrimack Pharmaceuticals, Inc.	01 Nov 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NAPOLI-1 (Pubmed \| Br J Cancer)	Phase 2	Metastatic Pancreatic Cancer Second line CA19-9	40	PEP02 (MM-398) 120 mg m(-2)	dgrvqkcfwy(wxarvngczx) = fqbopixfcd eekcuktkjn (pfbreqghqu ) View more	Positive	01 Aug 2013

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