[Translation] A randomized, double-blind, double-dummy, placebo-controlled, multicenter clinical study of K-001 in the treatment of advanced pancreatic cancer

在同时接受最佳支持治疗的三线及以上晚期胰腺癌患者中评价K-001治疗的有效性和安全性

[Translation]

To evaluate the efficacy and safety of K-001 in patients with advanced pancreatic cancer who are receiving third-line or higher-level treatment concurrently with best supportive care

Start Date29 Dec 2017

Sponsor / Collaborator

Beijing Huashitianfu Biomedical Technology Co., Ltd.

ChiCTR-IIR-17013424 / SuspendedPhase 2IIT

A Randomized, Double Blinded, Parallel-controlled, Multi-center Phase II/III Study to Compare the Best Support Care (BSC) Plus K-001 Versus BSC Plus Placebo for the Third-line and Later Treatment of Patients With Advanced Pancreatic Cancer

Start Date01 Dec 2017

Sponsor / Collaborator-

CTR20160052 / CompletedPhase 1

K-001治疗晚期胰腺癌的单药累积性耐受性I期临床研究

[Translation] Phase I clinical study of cumulative tolerance of K-001 as a single agent in the treatment of advanced pancreatic cancer

1、评价患者对K-001单药的不良反应和耐受程度，提供安全的剂量范围； 2、初步推算合理的剂量和给药方案； 3、初步观察疗效；

[Translation]

1. Evaluate the adverse reactions and tolerance of patients to K-001 monotherapy and provide a safe dosage range; 2. Preliminarily calculate the reasonable dosage and administration schedule; 3. Preliminarily observe the efficacy;

Start Date04 Feb 2016

Sponsor / Collaborator

Beijing Huashitianfu Biomedical Technology Co., Ltd.

100 Clinical Results associated with Peptidoglycan complex of spirulina(Hwealth Pharmaceutical)

100 Translational Medicine associated with Peptidoglycan complex of spirulina(Hwealth Pharmaceutical)

100 Patents (Medical) associated with Peptidoglycan complex of spirulina(Hwealth Pharmaceutical)

Literatures (Medical) associated with Peptidoglycan complex of spirulina(Hwealth Pharmaceutical)

01 Dec 2021·BMC CancerQ2 · MEDICINE

A phase I study of the safety and activity of K-001 in patients with advanced pancreatic ductal adenocarcinoma

Q2 · MEDICINE

ArticleOA

Author: Yang, Haiyan ; Zhang, Haiyan ; Wang, Yu ; Cui, Jiujie ; Liu, Jue ; Chen, Donghui ; Hu, Jiong ; Han, Ting ; Biskup, Ewelina ; Mao, Tiebo ; Liu, Min ; Pan, Yaotian ; Jiao, Feng ; Wang, Liwei

AbstractBackgroundPancreatic ductal adenocarcinoma (PDAC) is a deadly disease that lack of effective therapeutic drugs. K-001 is an oral antitumor drug made from active ingredients of marine microorganisms. The current study aimed to evaluate safety and antitumor activity of K-001 in patients with advanced PDAC.MethodsIn this phase I, open-label trial, patients with advanced PDAC were recruited to a dose-escalation study in a standard 3 + 3 design. K-001 was administered twice daily in four-week cycles, and dose escalation from 1350 mg to 2160 mg was evaluated twice daily. Physical examination and laboratory tests were done at screening and then weekly. The safety, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of K-001 were assessed while tumor response was estimated by Response Evaluation Criteria in Solid Tumor (RECIST).ResultsEighteen patients with advanced PDAC were screened, and twelve eligible patients were analyzed in the study. No DLT was observed. Totally, 47 adverse events (AEs) presented, and 14 drug-related AEs were reported in 7 patients, including 8 grade 1 events (57.1%) and 6 grade 2 events (42.9%). There was no grade 3 or 4 drug-related AE. In these 14 drug-related AEs, the most frequent ones were dyspepsia (21.4%), followed by flatulence, constipation, and hemorrhoid bleeding (above 10% of each). Among all 12 patients, 10 patients (83.3%) maintained stable disease (SD), and 2 patients (16.7%) had progressive disease (PD). The objective response rate (ORR) was 0% and the disease control rate (DCR) was 83.3%.ConclusionsK-001 manifests satisfactory safety and tolerability, as well as meaningful antitumor activity in advanced PDAC patients. Further evaluation of K-001 in phase II/III appears warranted.Trial registrationNCT02720666. Registered 28 Match 2016 - Retrospectively registered.

01 Aug 2021·Journal of Food BiochemistryQ3 · AGRICULTURAL & FORESTRY SCIENCE

Spirulina platensis ( Arthrospira platensis ) attenuates Cyclophosphamide‐induced reproductive toxicity in male Wistar rats: Evidence for sperm apoptosis and p53/Bcl‐2 expression

Q3 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Malekinejad, Hasan ; Hasanzadeh, Shapour ; Delirezh, Norouz ; Shahrooz, Rasoul ; Afkhami‐Ardakani, Mohammad

Cyclophosphamide is an antitumor agent that causes disorders in fertility. This study aimed to evaluate the protective effects of Spirulina platensis against Cyclophosphamide-induced testicular toxicity. 42 male Wistar rats were randomly divided into six groups. Experimental groups included three groups. The first experimental group received Cyclophosphamide at a dose of 5 mg/kg body weight (BW) orally. The second and third experimental groups received 5 mg/kg BW Cyclophosphamide and 500 and 1,000 mg/kg BW S. platensis orally, respectively. The control groups included a control group, and two S. platensis control groups. Following 28 days, two flow cytometry techniques were used to determine sperm apoptosis and testicular protein expression of tumor protein (p53) and B-cell lymphoma 2 (Bcl-2). p53 is a tumor suppressor protein that causes the cell to enter the apoptosis cycle after DNA damage and Bcl-2 is an anti-apoptotic protein that acts through the mitochondrial pathway of apoptosis. FITC-Annexin V assay was used for sperm apoptosis evaluation. For protein expression assay, primary and secondary antibodies staining were performed. The Cyclophosphamide group showed a significant increase in sperm apoptosis compared to the control group. Cyclophosphamide significantly increased p53 and decreased Bcl-2 expression compared to the control group. S. platensis co-treated groups exhibited a significant decrease in sperm apoptosis compared to the Cyclophosphamide group. Moreover, S. platensis co-treated groups displayed a significant decreasing in p53 and increasing in Bcl-2 expression compared to the Cyclophosphamide group. The results of this study indicated that S. platensis protected rats against Cyclophosphamide-induced reproductive toxicity. PRACTICAL APPLICATIONS: Cyclophosphamide is the chemotherapy agent used to treat different cancers. Cyclophosphamide has side effects on the male reproductive system. Spirulina plantesis has a protective effect because of its antioxidant and anti-apoptotic properties. Co-administration of Spirulina plantesis with Cyclophosphamide reduces sperm apoptosis also decreases P53 protein expression and increases Bcl-2 protein expression. This study validated the anti-apoptotic potential of Spirulina plantesis against Cyclophosphamide-induced male reproductive toxicity.

01 Nov 2010·Planta MedicaQ3 · MEDICINE

Enhancement of Natural Killer Cell Activity in Healthy Subjects by Immulina®, aSpirulinaExtract Enriched for Braun-Type Lipoproteins

Q3 · MEDICINE

Article

Author: Christensen, Ole ; Pasco, David S. ; Walsted, Anette ; Wu, Xiangmei ; Schjorring-Thyssen, Michelle ; Balachandran, Premalatha ; Pugh, Nirmal D. ; Sufka, Kenneth J. ; Enevold, Christian ; Nielsen, Claus Henrik ; Tamta, Hemlata

Immulina®, a commercial extract of Arthrospira (Spirulina) platensis is a potent activator of THP-1 monocytes and CD4+ T cells IN VITRO and enhances several immunological functions in mice. We further characterized Immulina® by determining that Braun-type lipoproteins are responsible for a major portion of the IN VITRO monocyte activation exhibited by this material. In order to understand the effect of Immulina® on NK cell activity, a pilot study was conducted on ten healthy North American individuals who supplemented their diet with Immulina® (400 mg/day) for seven days. We observed a 40% average increase in the killing of K562 tumor cells by NK cells (p < 0.01) after Immulina® supplementation. In a separate placebo-controlled, crossover study involving 11 healthy Danish subjects, we observed increased mRNA expression of the NK cell marker NKG2D by 37% (p = 0.02) and by 55% (p = 0.0003) after administration of Immulina® (200 mg and 400 mg per day, respectively) for seven days. The mRNA expression of the NK- and T-cell marker perforin increased by 75% (p = 0.008) after administration of 400 mg Immulina® per day. Both markers displayed significant dose-dependent effects (p = 0.0003 and p = 0.02, respectively). The ratio between CD56 (bright) and CD56 (dim) NK cells was not affected by Immulina® administration. In summary, two independent studies showed enhancement of NK cell activity following administration of Immulina® for seven days.

100 Deals associated with Peptidoglycan complex of spirulina(Hwealth Pharmaceutical)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	Phase 3	CN	Beijing Huashitianfu Biomedical Technology Co., Ltd.	19 Mar 2014
Pancreatic Cancer	Phase 3	CN	Shanghai Jiao Tong University School of Medicine	-
Pancreatic Cancer	Phase 3	CN	Beijing Huashitianfu Biomedical Technology Co., Ltd.	-
Advanced gastric carcinoma	Phase 2	CN	Beijing Huashitianfu Biomedical Technology Co., Ltd.	15 May 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02720666 (ASCO2020)	Phase 1	Advanced Pancreatic Ductal Adenocarcinoma	12	K-001	ytjpbgedni(krhofjdlxn) = both grade 2 ijtwwzwbyx (iegrhdnxnk ) View more	Positive	25 May 2020

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