Spago Nanomedical has Submitted Application to Start Tumorad(R) Clinical Phase I/IIa Study

LUND, SWEDEN / ACCESSWIRE / May 23, 2023 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F) Spago Nanomedical AB (publ) today announced that the final step in the preparations for the clinical phase I/IIa trial in cancer patients, Tumorad-01, with its leading candidate drug 177Lu-SN201 has begun in Australia. The application to start the study has been sent to the ethics committee and patient enrollment is expected to start in the summer 2023.

The application process includes submission to an Australian Human Research Ethics Committee (HREC), followed by a Clinical Trial Notification (CTN) to the Australian Therapeutic Goods Administration (TGA). Patient recruitment is expected to start immediately following approval.

"This marks the transition into clinical development of our radionuclide therapy program Tumorad and is a very important milestone for Spago Nanomedical. Australia offers an excellent framework for our study by provision of several competent clinical sites, an expedited regulatory pathway, and beneficial financial support of R&D costs. This allows us to bring Tumorad to cancer patients in a rapid and cost-effective way, and we expect to include the first patient in the summer," said CEO Mats Hansen.

Spago Nanomedical plans to commence clinical development of 177Lu-SN201 with a phase I/IIa, dose escalation and dose expansion, first-in-human study in patients with advanced cancer. The primary aim of the study is to evaluate the safety, tolerability and early efficacy of 177Lu-SN201 The Phase I part of the study will include up to 30 patients. Study details and updates will be published at www.clinicaltrials.gov.

Clinical evidence of selective tumor accumulation of Spago Nanomedical´s functional nanoparticles has previously been generated with the MRI contrast agent SN132D in patients with breast cancer. The radioisotope lutetium-177 (177Lu) is clinically effective against cancer. Combined with Spago Nanomedical´s carefully designed polymeric nanomaterial, the candidate drug 177Lu-SN201 provides for a promising new radionuclide therapy for physiological targeting and tumor selective treatment of cancer with potential use in several different tumor types.

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For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se

Spago Nanomedical AB is a Swedish nanomedicines company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise diagnosis and treatment of life-threatening and debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see www.spagonanomedical.se.

FNCA Sweden AB is the Certified Adviser of the company.

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Spago Nanomedical has submitted application to start Tumorad® clinical phase I/IIa study

SOURCE: Spago Nanomedical

View source version on accesswire.com:https://www.accesswire.com/756595/Spago-Nanomedical-has-Submitted-Application-to-Start-TumoradR-Clinical-Phase-IIIa-Study

VVN539 met primary study endpoints in US phase IIa clinical study for the treatment of glaucoma

SHANGHAI, June 4, 2023 /PRNewswire/ -- This was a Phase 2, double-masked, randomized, vehicle-controlled, dose-response study to assess the safety and ocular hypotensive efficacy of VVN539 in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OHT). The primary objective was to evaluate the ocular hypotensive efficacy of 2 concentrations of VVN539 Ophthalmic Solution (0.04% and 0.02%) in patients with POAG or OHT, and the secondary objective was to evaluate the ocular and systemic safety of VVN539 Ophthalmic Solution.

In this double-masked, vehicle and dose-controlled, and parallel first in human study, topical ocular dosing with VVN539 Ophthalmic Solution resulted in a clinically and statistically significant decrease in elevated intraocular pressure (IOP) in subjects with OHT and POAG.  The 0.04% VVN539 Ophthalmic Solution was statistically superior to its vehicle at all 9 diurnal time points over the course of the 21 days study.  The magnitude of the decrease from unmedicated baseline was 5 to 6 mm Hg. The 0.02% VVN539 Ophthalmic Solution provided statistically significant decreases from unmedicated baseline relative to its vehicle at majority of time points. Consistent with other studies of this type, there was a 1-2 mm Hg reduction in IOP seen in the vehicle group. The results of this Phase 2 study indicate that VVN539 appears safe and well tolerated in adult subjects with POAG or OH.

Overall, VVN539 Ophthalmic Solution exhibited statistically and clinically significant ocular hypotensive activity and was well tolerated for the treatment of patients with primary open-angle glaucoma and ocular hypertension. Further clinical studies of the drug will explore the therapeutic potential in comparison with a first-line hypotensive drug in a lager patient population.

About VVN539

VVN539 is a first-in-class, duo MOA small molecule for the treatment of glaucoma.  It acts directly at trabecular meshwork, increases the outflow of aqueous humor, and thus lowers intraocular pressure (IOP). In a preclinical animal model, VVN539 exhibited remarkable IOP lowering efficacy, and this innovative drug is expected to be competitive in the global glaucoma market.

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About Vivavision Biotech Ltd.

VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. Besides VVN001 program, VivaVision is developing VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. Vivavision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases.

VivaVision is led by experienced drug hunters in the fields of ophthalmology. The company is inspired to be a global leader of ophthalmic drug discovery. VivaVision is backed by leading life sciences investors including Sequoia, Lapam, Cenova. CTJA, etc.

To learn more about VivaVision, Visit: www.vivavisionbio.com 

Media Contact: support@vivavisionbio.com 

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View original content:https://www.prnewswire.com/news-releases/vvn539-met-primary-study-endpoints-in-us-phase-iia-clinical-study-for-the-treatment-of-glaucoma-301841129.html

SOURCE VIVAVISION BIOTECH LTD

VVN539 met primary study endpoints in US phase IIa clinical study for the treatment of glaucoma

SHANGHAI, June 4, 2023 /PRNewswire/ -- This was a Phase 2, double-masked, randomized, vehicle-controlled, dose-response study to assess the safety and ocular hypotensive efficacy of VVN539 in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OHT). The primary objective was to evaluate the ocular hypotensive efficacy of 2 concentrations of VVN539 Ophthalmic Solution (0.04% and 0.02%) in patients with POAG or OHT, and the secondary objective was to evaluate the ocular and systemic safety of VVN539 Ophthalmic Solution.

In this double-masked, vehicle and dose-controlled, and parallel first in human study, topical ocular dosing with VVN539 Ophthalmic Solution resulted in a clinically and statistically significant decrease in elevated intraocular pressure (IOP) in subjects with OHT and POAG.  The 0.04% VVN539 Ophthalmic Solution was statistically superior to its vehicle at all 9 diurnal time points over the course of the 21 days study.  The magnitude of the decrease from unmedicated baseline was 5 to 6 mm Hg. The 0.02% VVN539 Ophthalmic Solution provided statistically significant decreases from unmedicated baseline relative to its vehicle at majority of time points. Consistent with other studies of this type, there was a 1-2 mm Hg reduction in IOP seen in the vehicle group. The results of this Phase 2 study indicate that VVN539 appears safe and well tolerated in adult subjects with POAG or OH.

Overall, VVN539 Ophthalmic Solution exhibited statistically and clinically significant ocular hypotensive activity and was well tolerated for the treatment of patients with primary open-angle glaucoma and ocular hypertension. Further clinical studies of the drug will explore the therapeutic potential in comparison with a first-line hypotensive drug in a lager patient population.

About VVN539

VVN539 is a first-in-class, duo MOA small molecule for the treatment of glaucoma.  It acts directly at trabecular meshwork, increases the outflow of aqueous humor, and thus lowers intraocular pressure (IOP). In a preclinical animal model, VVN539 exhibited remarkable IOP lowering efficacy, and this innovative drug is expected to be competitive in the global glaucoma market.

About Vivavision Biotech Ltd.

VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. Besides VVN001 program, VivaVision is developing VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. Vivavision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases.

VivaVision is led by experienced drug hunters in the fields of ophthalmology. The company is inspired to be a global leader of ophthalmic drug discovery. VivaVision is backed by leading life sciences investors including Sequoia, Lapam, Cenova. CTJA, etc.

To learn more about VivaVision, Visit: www.vivavisionbio.com 

Media Contact: support@vivavisionbio.com 

SOURCE VIVAVISION BIOTECH LTD

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