Archexin (HC0201)
/ Opus Genetics, Zhejiang Haichang Bio-Tech
- LARVOL DELTA
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March 06, 2024
Anti-tumor effect of the combination of a lipid nanoparticle suspension of an AKT-1 antisense oligonucleotide (WGI-0301) with tyrosine kinase inhibitors in an orthotopic murine tumor model
(AACR 2024)
- "Background: Archexin is a fully phosphorothioated 20-mer antisense oligonucleotide, complementary to AKT-1 mRNA, which leads to the inhibition of translation and the downstream pathway activities of AKT-1 mRNA... The anti-tumor effect of combining WGI-0301 with Lenvatinib/Sorafenib/Cabozantinib was assessed using a Hep3B-Luciferase orthotopic mouse tumor model... The combination of WGI-0301 with TKIs demonstrated superior anti-tumor efficacy over TKI monotherapy in the absence of substantial increase in toxicity. This finding warrants further robust clinical investigation in patients with advanced HCC."
Preclinical • Oncology • Solid Tumor • AKT1
March 14, 2023
The anti-tumor and anti-angiogenic effects of a lipid nanoparticle suspension of an AKT-1 anti-sense oligonucleotide
(AACR 2023)
- "Archexin is a fully phosphorothioated 20-mer antisense oligonucleotide, which can specifically bind to AKT-1 mRNA resulting in RNase H-based AKT-1 downregulation. Data obtained demonstrated anti-tumor and anti-angiogenesis efficacy of WGI-0301. In addition, combining WGI-0301 with Sorafenib or Lenvatinib resulted in increased anti-angiogenetic activity relative to monotherapy. WGI-0301 warrants further investigation as a selective AKT-1 inhibitor."
Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • AKT1
March 14, 2023
Evaluation of an AKT-1 antisense oligonucleotide in combination with Lenvatinib and Everolimus in Renca-luciferase syngeneic orthotopic murine tumor model
(AACR 2023)
- "Three drugs combination of Archexin, Lenvatinib and Everolimus, demonstrated superior anti-tumor efficacy compared to the two-drug combination currently used in the clinic. This finding suggests the three-drug combination warrant investigation in the clinical trial in the patients with advanced renal cancer."
Combination therapy • Preclinical • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • AKT1
February 19, 2019
Results of a phase II study to evaluate the safety and efficacy of RX-0201 in combination with everolimus in subjects with metastatic renal cell carcinoma (mRCC).
(ASCO-GU 2019)
- P1b/2; "In this mRCC population with extensive prior therapy, RX-0201 in combination with everolimus was safe, well-tolerated, and showed promising efficacy. The results also support the therapeutic significance of the AKT-1/mTOR pathway in mRCC."
Clinical • Combination therapy • P2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor
February 17, 2019
Results of a phase II study to evaluate the safety and efficacy of RX-0201 in combination with everolimus in subjects with metastatic renal cell carcinoma (mRCC).
(ASCO-GU 2019)
- P1b/2; "In this mRCC population with extensive prior therapy, RX-0201 in combination with everolimus was safe, well-tolerated, and showed promising efficacy. The results also support the therapeutic significance of the AKT-1/mTOR pathway in mRCC."
Clinical • Combination therapy • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor
September 29, 2011
Rexahn completes patient enrollment in cancer drug trial
(PBR)
- P2, N=35; Rexahn has completed patient enrollment in its Phase II clinical trial of Archexin, to treat metastatic pancreatic cancer; The study is said to have met its end point; The company expects to report preliminary results in the first half of 2012
Anticipated P2 data • Enrollment completion • Pancreatic Cancer
September 28, 2011
Rexahn Pharmaceuticals completes patient enrollment for Archexin phase II clinical trial in metastatic pancreatic cancer
(Businesswire)
- P2, N=35; Rexahn announced the completion of pt enrollment for its P2 clinical trial of Archexin in combination with gemcitabine in metastatic pancreatic cancer; The primary efficacy endpoint of the study is overall survival; Trial enrolled approximately 35 pts at sites in the US & India
P2 enrollment completion • Oncology • Pancreatic Cancer
September 12, 2013
Rexahn awarded patent in Europe for cancer drug Archexin
(Rexahn Press Release)
- "Rexahn Pharmaceuticals...announced that the European Patent Office has granted the Company a patent, EP 1546180, for its clinical development candidate Archexin® and its use for inhibiting the activated form of Akt-1 (phospho-Akt1)for the treatment of cancer....Company to initiate Phase IIa clinical trials in Q4 of 2013."
Anticipated new P2 trial • Patent • Oncology
September 04, 2013
Rexahn Pharmaceuticals provides a clinical development and financial update
(Rexahn Press Release)
- "A scientific, clinical and business analysis of potential indications for a Phase IIa clinical trial with Archexin® was completed following the Phase I trial....Rexahn anticipates updating investors on the tumor type selection and Phase IIa trial timeline in the fourth quarter of 2013."
Anticipated new P2 trial • Oncology
May 19, 2014
Rexahn: Q1 2014 Results
(Rexahn Pharmaceuticals, Inc)
- Anticipated completion of initial safety component of P2a proof-of-concept trial for renal cell carcinoma in Q4 2014
Anticipated trial completion date • Oncology • Renal Cell Carcinoma
January 11, 2016
Rexahn Pharmaceuticals’ Archexin shows dose-dependent tumor reduction in a phase IIa clinical study
(GlobeNewswire)
- P2a, N=NA; "Early evidence of the potential clinical activity of Archexin in combination with everolimus has been observed. Among the patients enrolled in the study, three patients have experienced stable disease, which has persisted for 383, 170 and 115 days (as of January 6, 2016). In addition, two patients have experienced a reduction from baseline in their tumor size of 16% (125 mg/m2/day) and 36% (200 mg/m2/day) following four and two treatment cycles, respectively."
Conference • P2 data • Oncology • Renal Cell Carcinoma
April 24, 2016
Rexahn: Investor Presentation
(Rexahn Pharmaceuticals, Inc)
- Anticipated completion of P2 POC trial (NCT02089334) for metastatic renal cell carcinoma in 2016
Anticipated trial completion date • Oncology • Renal Cell Carcinoma
March 16, 2016
Folate receptor-targeted lipid coated albumin nanoparticles (F-LCAN) for therapeutic delivery of RX-0201 (Archexin), an antisense oligonucleotide against Akt-1
(AACR 2016)
- "In a KB xenograft tumor model, F-LCAN-RX-0201 exhibited higher tumor suppressive activity compared to the non-targeted LCAN-RX-0201 at 16 mg/kg (as a RX-0201 amount) without body weight changes."
Preclinical • Oncology
June 26, 2016
Rexahn: Investor Presentation
(Rexahn Pharmaceuticals, Inc)
- "250 mg/m2/day Dose Group: 32% tumor reduction; 6 cycles of therapy"
P2a data • Oncology • Renal Cell Carcinoma
May 18, 2016
Results from a phase 1b/2 study of RX-0201, a novel AKT-1 antisense, combined with everolimus to treat metastatic clear cell renal carcinoma
(ASCO 2016)
- P1/2, N=10; NCT02089334; "Based on the tolerability, 250 mg/m2/day RX-0201 dose was declared the recommended Stage 2 dose. Four subjects in the Stage 1 of Phase 1b study have experienced stable disease for 383, 191, 129 and 58 days; also a tumor burden reduction from 16% to 38.5% was seen in four subjects. RX-0201 PK demonstrated a dose proportional exposure."
P1/2 data • Oncology • Renal Cell Carcinoma
November 21, 2015
Rexahn: Investor Presentation
(Rexahn Pharmaceuticals, Inc)
- “Safe and well tolerated at the doses tested to date”; “2 patients experienced stable disease persisting up to 170 and 334 days (as of Oct 28/2015)”; “1 patient with stable disease experienced a 15% tumor reduction after 4 cycles of therapy”
P2a data • Oncology • Renal Cell Carcinoma
February 06, 2016
Rexahn: Fact Sheet
(Rexahn Pharmaceuticals, Inc)
- Anticipated initiation of stage 2 (randomized portion) of P2a trial (NCT02089334) in metastatic renal cell cancer in early 2016; Anticipated interim data from stage 2 (randomized) P2a trial (NCT02089334) in metastatic renal cell cancer in H2 2016;
Anticipated P2a data • Anticipated trial initiation date • Oncology • Renal Cell Carcinoma
August 28, 2012
Rexahn Pharmaceuticals announces positive top-line phase IIa data for Archexin in patients with metastatic pancreatic cancer
(Rexahn Pharmaceuticals, Inc)
- P2, N=31; Median survival for Archexin in combination with gemcitabine was 9.1 months vs. 5.65 months for single agent gemcitabine (historical survival data); Frequently reported AEs were constipation, nausea, abdominal pain and pyrexia
P2a data • Oncology • Pancreatic Cancer
July 02, 2015
Rexahn: Corporate Presentation
(Rexahn Pharmaceuticals, Inc)
- Anticipated initial combination safety data from P2a trial (NCT02089334) in combination with Afinitor for metastatic renal cell carcinoma in mid-2015
Anticipated P2a data • Oncology • Renal Cell Carcinoma
February 08, 2018
Rexahn Pharmaceuticals announces collaboration with Zhejiang Haichang Biotechnology Co., Ltd. for the development of RX-0201 (Archexin) for the treatment of hepatocellular carcinoma
(GlobeNewswire)
- "Under the terms of the agreement, Haichang will develop a nano-liposomal formulation of RX-0201 using its proprietary QTsome™ technology and conduct certain pre-clinical and clinical activities through completion of a Phase IIa proof-of-concept clinical trial for the treatment of HCC....In connection with the agreement with Haichang, Rexahn plans to discontinue the internally funded programs of Archexin and will cease enrollment in the current Phase IIa clinical study of Archexin in metastatic renal cell carcinoma (mRCC)."
Enrollment closed • Licensing / partnership • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer
March 19, 2016
Rexahn: Annual Report 2015
(Rexahn Pharmaceuticals, Inc)
- Anticipated expiry of patents in US and ex-US between 2020-2030
Anticipated patent expiry • Oncology
February 13, 2016
Rexahn: BIO CEO & Investor Conference
(Rexahn Pharmaceuticals, Inc)
- "Stage 1 completed; safe and well tolerated at the doses tested to date"; "MTD established (250 mg/m2/day)"; "3 patients experienced stable disease persisting up to 115, 170, 383 days (as of Jan 6, 2016)"; "Preliminary evidence of dose-dependent tumor reduction: 125 mg/m2/day Dose Group: 16% tumor reduction; 4 cycles of therapy, 200 mg/m2/day Dose Group: 36% tumor reduction; 2 cycles of therapy"
P2a data • Oncology • Renal Cell Carcinoma
January 10, 2018
Archexin: Initial data read-out from P2a trial (NCT02089334) for metastatic RCC in Q1 2018
(10th Annual Conference Biotech Showcase, Rexahn Pharmaceuticals, Inc)
P2a data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer
January 10, 2018
Archexin: Initial data read-out from P2a trial (NCT02089334) for metastatic RCC in Q1 2018
(10th Annual Conference Biotech Showcase, Rexahn Pharmaceuticals, Inc)
P2a data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer
September 13, 2014
Rexahn: Corporate Presentation
(Rexahn Pharmaceuticals, Inc)
- "Archexin®: Phase I and Phase IIa Clinical trials (completed)"; "Phase I (Cancer patients with solid tumors)"; "MTD was 250 mg/m
2/
d in patients with an advanced cancer after up to two cycles of treatment"; "The dose limiting toxicity was Grade 3 fatigue; no significant hematological abnormalities"
P1 data • Oncology
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