A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety and Efficacy of SB-01 for Injection for the Treatment of Lumbar Degenerative Disc Disease

The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.

开始日期2022-08-19

申办/合作机构

Spine BioPharma, Inc.初创企业

[+1]

NCT02320019 / Completed临床2期

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Trial to Evaluate the Efficacy and Safety of YH14618 in Patients With Lumbar Degenerative Disc Disease

Research Hypothesis:
There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.

开始日期2015-03-01

申办/合作机构

Yuhan Corp.

NCT01526330 / Completed临床1/2期

A Double-blind, Randomized, Parallel, Placebo Controlled, Phase I/II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH14618 Following Single Intradiscal Injection in Patients With Degenerative Disc Disease

The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.

开始日期2012-05-01

申办/合作机构

Yuhan Corp.

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2013-01-01·Spine2区 · 医学

Anabolic Effects of Peniel 2000, a Peptide That Regulates TGF-β1 Signaling on Intervertebral Disc Degeneration

2区 · 医学

Article

作者: Moon, Eun-Joung ; Lee, Je-Wook ; Kim, Ok-Soon ; Kwon, Young-Joon ; Chung, Yeon Gu ; Kim, Hae-Jin

STUDY DESIGN:

An in vitro study with bovine intervertebral disc (IVD) cells and an in vivo study with a rabbit disc degeneration model on the extracellular matrix metabolism by a biglycan-derived peptide (Peniel 2000; P2K).

OBJECTIVE:

To investigate the mechanism for P2K-induced increases in extracellular matrix and in vitro and in vivo effects of the peptide on IVD.

SUMMARY OF BACKGROUND DATA:

Transforming growth factor-β (TGF-β) has a functional versatility on the metabolism of IVD cells, suggesting that the regulation of TGF-β signaling is important in IVD degeneration. P2K was explored by an in silico drug discovery strategy to regulate TGF-β signaling.

METHODS:

The putative target of P2K was verified by Biacore 3000 analysis and affinity purification using biotin-P2K. A monolayer culture system of bovine IVD cells was used to demonstrate the mechanism underlying the anabolic effects of P2K. Smad signaling and extracellular matrix metabolism of the IVD cells were investigated by Western blot and reverse transcription-polymerase chain reaction, respectively. The in vivo effect of P2K on degenerated disc was investigated using a rabbit model of disc degeneration. In 14 New Zealand white rabbits, disc degeneration was induced by percutaneous annular punctures. After 4 weeks, 3 consecutive discs in the same animal were treated with 5% lactose or P2K per disc. Twelve weeks after the treatment, the regenerative activity in the disc was examined by radiography, magnetic resonance imaging, and biochemical and histological analyses.

RESULTS:

Direct binding of P2K to an active form of TGF-β1 was shown. Type II collagen and aggrecan were increased in TGF-β1/P2K-treated bovine IVD cells, compared with nontreated and TGF-β1-treated cells.In in vivo analysis, a single injection of P2K increased the disc height (P < 0.001) on the radiographs and improved the magnetic resonance imaging grade (P < 0.05) compared with controls. Biochemical analysis, showed a significant increase in PG content because of P2K treatment (P < 0.05). Histological analysis using disc degeneration grades demonstrated improvement in P2K-treated discs (P <0.01).

CONCLUSION:

A novel peptide, P2K, regulating TGF-β1 signaling had an anabolic effect on bovine IVD cells and rabbit degenerated discs. The results suggest that P2K has considerable potential as a treatment of degenerative disc disease.

2001-08-01·AIDS (London, England)2区 · 医学

`Chemical condoms’ for the prevention of HIV infection: evaluation of novel agents against SHIV89.6PDin vitro and in vivo

2区 · 医学

Article

作者: Nunn, Andrew ; Jeffries, Don ; Stott, Jim ; Almond, Neil ; Weber, Jonathan ; O'Connor, Tim ; McCormack, Sheena ; Stone, Alan ; Darbyshire, Janet ; Kitchen, Valerie

BACKGROUND:

Vaginal agents which are antiviral and/or inhibit the entry of HIV into the cell could prevent heterosexual transmission of HIV, and protect women who cannot negotiate condom use.

METHODS:

Four agents have been investigated for activity in vitro and in vivo against SHIV(89.6PD): two anionic polymers, dextrin-2-sulphate (D2S) and PRO 2000 (P2K), and two virucidal agents; a non-ionic detergent, nonoxynol-9 (N9) and a cyclic peptide ionophore, gramicidin-D (GD). All four agents were investigated in rhesus macaques, using an intra-vaginal challenge of two inoculations of 1 x 104 50% tissue culture infectious doses (TCID)50 of SHIV(89.6PD).

RESULTS:

D2S, P2K, GD and N9 all inhibited SHIV(89.6PD) in vitro. In vivo, three out of four control macaques were infected as judged by viral culture, seroconversion, DNA and RNA PCR; infection was confirmed in four out of eight macaques pre-treated with P2K, two out of four pre-treated with D2S, one out of four pre-treated with N9, two out of four pre-treated with GD and four out of four pre-treated with D2S + GD, a combination additive in vitro.

INTERPRETATION:

D2S and PRO-2000, novel inhibitors of HIV entry, showed evidence of protection in vivo, comparable to that seen with the virucide, N9. These data, together with the results of phase I and phase II studies in healthy women which have shown minimal toxicity, support plans for a phase III efficacy trial of chemically simple inhibitors of HIV entry with low toxicity, for the prevention of HIV infection in women.

项与 Remedisc 相关的新闻（医药）

2024-07-10

·PRNewswire

Spine BioPharma, Inc. Announces Agreement with Ensol BioSciences, Inc. to Expand Indications for SB-01 For Injection

NEW YORK, July 10, 2024 /PRNewswire/ -- Spine BioPharma, Inc., a company committed to developing non-opiate, non-surgical therapies for the treatment of pain related disabilities, today announced that it has signed an agreement with Korean Company Ensol BioSciences, Inc. to expand the indications (treatment scope) of its therapeutic drug treatment candidate, SB-01 For Injection. The agreement, valued at a total of $155 million, grants Spine BioPharma the exclusive rights to develop and commercialize SB-01 For Injection, for all additional indications beyond spine-related diseases, such as Osteoarthritis, fibrotic diseases, and Oncological indications. In 2018, Spine BioPharma acquired the right to develop and commercialize SB-01 For Injection globally excluding Korea, from South Korean pharmaceutical and chemical company, Yuhan Corporation (who had originally licensed it from Ensol BioSciences). Spine BioPharma is currently conducting its SB-01 Phase 3 MODEL Study ( Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine), the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with Degenerative Disc Disease (DDD) and anticipates completing trial enrollment of the 400-patient study in September 2024. (Clinicaltrials.gov: NCT05516992). Marc Viscogliosi, CEO of Spine BioPharma, stated, "We are very pleased to have finalized this agreement with Ensol BioSciences, and excited about the future portfolio expansion opportunities it provides, beyond spine-related diseases. This agreement, coupled with the anticipated conclusion of the SB-01 Phase 3 MODEL Study enrollment, certainly broadens Spine BioPharma's strategic framework considerations to address the unmet needs of patients suffering from pain related disabilities, and beyond". About SB-01 For Injection SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta. TGF-Beta is a pleiotropic cytokine expressed by almost every tissue and cell type, is stored in abundance in the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In many diseases, there are high concentrations of TGF-Beta that result in a spectrum of negative downstream effects including inflammation, fibrosis, hypertension, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects. Considering this mechanism of action, SB-01 has potential in the treatment of other diseases beyond degenerative disc disease including osteoarthritis, fibrotic diseases, and other significant unmet medical needs. About Spine BioPharma Spine BioPharma is committed to developing non-surgical/non-opioid treatments that will reduce pain, restore function, and slow or stop pathological disease progression. Spine BioPharma's lead candidate, SB-01 For Injection, is a first-in-class treatment of degenerative disc disease, offering potential clinical benefits of pain relief, restoration of function, and prevention of disease progression. To learn more about Spine BioPharma, visit . Contact: Jason Gallagher Chief Commercial Officer & Chief Operating Officer [email protected] Office phone: (212) 583-9700 SOURCE Spine Biopharma, Inc

临床3期引进/卖出

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