DALLAS, TX — Oct. 10, 2024  — Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for retinal degenerative diseases today announced a productive FDA meeting for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP). Based on the regulatory feedback provided in the meeting, Nanoscope will commence with submission of a Biologics License Application (BLA) in Q1 2025.......[click link before for full article]

Cardiology and Heart Surgery

Despite advancements over the past several decades to help minimize the post-operative complications of cardiac surgery, many patients still experience an inflammatory response to cardiopulmonary bypass, when doctors use a heart-lung machine to continue to pump blood while the heart is arrested. This response can lead to prolonged ventilation, bleeding, stroke, and renal dysfunction, often increased time in the intensive care unit (ICU) and prolonged length of stay.....[click link before for full article]

Nanoscope Therapeutics Announces Positive Top-line Results from Randomized Controlled Trial of MCO-010 for Retinitis Pigmentosa

• MCO-010 achieved its primary and key secondary endpoints with statistical significance and no serious adverse events 
• Data from the Phase 2b RESTORE trial demonstrate clinically meaningful vision improvement in legally blind individuals with progressive and permanent neurodegeneration of the retina
• RESTORE is the first randomized, controlled trial of a mutation-agnostic gene therapy for a genetic disease
• Nanoscope anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024

DALLAS, March 26, 2024 /PRNewswire/ -- Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for inherited retinal diseases and age-related macular degenerations (AMD), today announced positive top-line results after the completion of the 2-year Phase 2b RESTORE randomized, controlled clinical trial of its lead program, MCO-010, a mutation-agnostic gene therapy for patients with permanent and severe vision loss from advanced retinitis pigmentosa (RP). .....[click link before for full article]

Nanoscope Therapeutics Provides Regulatory Update on MCO-010 for the Treatment of Retinitis Pigmentosa

• FDA and EU Regulators provide consistent advice that visual acuity may serve as primary endpoint to evaluate the effectiveness of MCO-010 in the treatment of low-vision retinitis pigmentosa (RP) patients 
• Regulatory feedback provides clarity for potential path to approval in the US and in Europe for MCO-010 in RP; Nanoscope preparing for immediate execution

DALLAS, Jan. 18, 2024 /PRNewswire/ -- Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for inherited retinal diseases and age-related macular degenerations (AMD), today provided an update following recent regulatory discussions with the U.S. Food and Drug Administration ("FDA") and from the Scientific Advice meeting with the ...regarding the regulatory path of MCO-010 for the treatment of RP .....[click link before for full article]

Nanoscope Therapeutics Continues Leadership Growth; Welcomes Accomplished Finance and Biotech Leader Glenn Sblendorio as Chairman of the Board

DALLAS, Dec. 4, 2023 /PRNewswire/ -- Nanoscope Therapeutics (Nanoscope), a clinical-stage biotechnology company developing gene therapies for inherited retinal diseases, today announced the appointment of Glenn Sblendorio as Chairman of the Board, effective immediately. With more than 30 years of exemplary experience marked by extensive executive leadership in the ophthalmic industry, Mr. Sblendorio will support Nanoscope in reaching its strategic vision.............[click link below for full article]

Renibus Announces First Patient Enrolled in PROTECT Phase 3 Study of RBT-1 to Reduce Post-operative Complications After Cardiothoracic Surgery

Pivotal trial will evaluate the effect of RBT-1 as a preconditioning agent in people undergoing cardiothoracic surgery

Estimated 600K CABG and valve repair surgeries in US/year, creating a large initial market for RBT-1

PROTECT enrollment on track, NDA filing anticipated early 2026

SOUTHLAKE, Texas, Oct. 25, 2023 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal and metabolic diseases, today announced that the first patient has been dosed in the pivotal Phase 3 PROTECT trial of RBT-1, the Company's first-in-a-new-class preconditioning agent under investigation to reduce post-operative complications following cardiothoracic surgery. PROTECT is expected to be conducted at approximately 35 sites in the United States and Canada............[click link below for full article]

CAGE Bio Announces Positive Topline Results From its Double-Blind Phase 2 Study Evaluating an Ionic Liquid formulation of 1% Tofacitinib In Patients with Atopic Dermatitis

SAN CARLOS, CA and FORT WORTH, TX / ACCESSWIRE / August 3, 2023 / CAGE Bio, Inc. (hereinafter "CAGE Bio") a biotechnology company focused on developing innovative drug therapies for localized treatment of immuno-dermatological disorders, today announced positive results from its randomized, vehicle controlled, phase 2 study evaluating the safety and efficacy of CGB-500, an ionic liquid formulation of 1% Tofacitinib, in patients with Atopic Dermatitis (AD)...........[click link below for full article]

Renibus Therapeutics Announces Breakthrough Therapy Designation from US FDA for RBT-1 for the Reduction in Risk of Post-Operative Complications in Patients Undergoing Cardiothoracic Surgery

SOUTHLAKE, Texas, July 11, 2023 /PRNewswire/ -- Renibus Therapeutics, Inc., ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to RBT-1 for the reduction in risk of post-operative complications in patients undergoing cardiothoracic surgery, and confirmed its alignment with the Company's planned Phase 3 pivotal trial.  ..........[click link below for full article]

Nanoscope Therapeutics Announces Presentation of Key Results from Phase 2b RESTORE Trial of MCO-010 for the Treatment of Retinitis Pigmentosa at the ARVO Annual Meeting

• 100% (18/18) MCO-010 patients experienced a clinically meaningful improvement in vision-guided mobility (MLYMT), near-field object recognition (MLSDT) or visual acuity (BCVA) (p=0.007 vs sham)
• 94.4% (17/18) MCO-010 patients showed vision improvement in the MLYMT or BCVA (p=0.008 vs sham)
• 88.9% (16/18) of MCO-010 patients experienced a clinically meaningful 2 or more luminance level improvement in MLYMT or MLSDT (p=0.02 vs sham)
• Favorable safety profile for MCO-010 with no serious or severe adverse event

DALLAS, April 27, 2023 /PRNewswire/ — Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced the presentation of key data from its Phase 2b multicenter, randomized, double-masked, sham-controlled RESTORE clinical trial. ..........[click link below for full article]

Nanoscope Therapeutics Announces Positive Topline Results from Phase 2b RESTORE Trial of MCO-010 for the Treatment of Retinitis Pigmentosa

DALLAS, March 30, 2023 /PRNewswire/ -- Nanoscope Therapeutics Inc., today announced topline results from the Phase 2b multicenter, randomized, double-masked, sham-controlled RESTORE clinical trial (NCT04945772)  of MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic therapy for vision restoration in advanced retinitis pigmentosa (RP), irrespective of gene mutation. MCO-010 has received both orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA) ..........[click link below for full article]

Renibus Therapeutics Announces Oral Presentation on RBT-1 Phase 2 Results at 2023 Society of Critical Care Medicine (SCCM) Meeting

-RBT-1 met the primary biomarker endpoint as well as several key clinical endpoints; positive data supports the potential for RBT-1 to improve postoperative outcomes in cardiothoracic surgery-

-RBT-1 treatment demonstrated a statistically significant reduction in ICU days and 30-day cardiopulmonary readmission rates; patients treated with RBT-1 had reduced time on ventilator as well as reduced rates of atrial fibrillation, hypervolemia, acute kidney injury, troponin I levels and anemia, indicating a broad, organ protective effect consistent with the mechanism of action of RBT-1-

-SCCM has awarded a STAR Research Achievement Award to the presentation as a recognition of excellence in critical care research-

-Planned pivotal Phase 3 study of RBT-1 to be initiated in Q1 2023-

SOUTHLAKE, Texas, Jan. 19, 2023 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biotech company focusing on the prevention and treatment of cardio-renal diseases, today announced that an oral presentation will be delivered on the positive results of RBT-1 from a Phase 2 Study at the Society for Critical Care Medicine (SCCM) 2023 Critical Care Congress at the Moscone Center in San Francisco, CA from January 21- 24, 2023 ..........[click link below for full article]

OncoNano Medicine’s Pegsitacianine Granted Breakthrough Therapy Designation for Real-Time Surgical Imaging by the Food and Drug Administration

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced that its lead clinical development candidate, pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, has received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) as an adjunct for the visualization of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.........[click link below for full article]

OncoNano Medicine Announces Positive Phase 2 Data for Pegsitacianine as an adjunct to Cytoreductive Surgery of Peritoneal Carcinomatosis

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced positive interim clinical results from an ongoing Phase 2 study of its lead clinical development candidate, pegsitacianine, for the detection of residual disease following cytoreductive surgery (CRS). Study results. were presented by Patrick Wagner, MD, Department of Surgical Oncology, Allegheny Health Network Cancer Institute, during an oral presentation at the World Molecular Imaging Congress (WMIC) in Miami, FL on September 29th.......[click link below for full article]

Nanoscope Therapeutics Announces Completion of Enrollment in STARLIGHT Phase 2 Clinical Trial of MCO-010 Optogenetic Gene Therapy for Stargardt Disease

DALLAS, Sept. 13, 2022 /PRNewswire/ -- Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced full enrollment of its Phase 2 clinical trial of MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for Stargardt disease. Six-month data from the Phase 2 STARLIGHT trial are expected in H1 2023......[click link below for full article]

Renibus Therapeutics Expands Leadership Team, Announces Appointments of New Chief Financial Officer and Chief Medical Officer

SOUTHLAKE, Texas, June 02, 2022 (GLOBE NEWSWIRE) -- Renibus Therapeutics® (“Renibus”), a clinical-stage biotech company focusing on the prevention and treatment of cardio-renal diseases, today announced the expansion of its leadership team with the appointment of Jamie Donadio as Chief Financial Officer, and Bhupinder Singh, MD, as Chief Medical Officer. Both Mr. Donadio and Dr. Singh will report to Renibus’ Chairman and Chief Executive Officer (CEO), Frank Stonebanks. The addition of these seasoned biotech leaders comes at a critical time, as Renibus continues to scale and develop its portfolio of products that aim to transform both the prevention and treatment of kidney disease.....[click link below for full article]

Renibus Therapeutics Strengthens IP Position with Additional US Patent 

Renibus Therapeutics granted patent approval for the novel aqueous iron composition of RBT-3, a product that targets prevention of cisplatin-induced nephrotoxicity

SOUTHLAKE, Texas, April 13, 2022 (GLOBE NEWSWIRE) -- Renibus Therapeutics® (“Renibus”), a clinical-stage biotech company focusing on the prevention and treatment of cardio-renal diseases, today announced that the United States Patent and Trademark Office (USPTO) has granted the addition of a new patent to its IP portfolio. The patent, No. 11,292,813, covers a novel aqueous iron composition of RBT-3,.....[click link below for full article]

Nanoscope Awarded Key U.S. Patent Protecting its Multi-Characteristic Opsin Gene Therapy Platform For Reversing Blindness

BEDFORD, Texas, Jan. 10, 2022 /PRNewswire/ -- Nanoscope Therapeutics Inc, a clinical-stage biotechnology company developing optogenetic gene therapies for retinal degenerative diseases, today announced that Nanoscope has been awarded U.S. patent 11,180,537 covering its Multi-Characteristic Opsin (MCO) optogenetic gene therapy platform for restoring vision. This award bolsters Nanoscope's existing intellectual property position .....[click link below for full article]

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced that the Cancer Prevention and Research Institute of Texas (CPRIT) will convert $18.4 million in grant award funding into an equity investment in OncoNano. Proceeds of the financing will be used to support OncoNano’s Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first internal therapeutic development program .... [ click link below for full article]

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc., a clinical-stage company utilizing the principles of molecular cooperativity in drug design to exploit universal tumor and immune targets to diagnose and treat cancer, today announced a multi-year collaboration with The University of Texas Southwestern Medical Center (UTSW) to discover and conduct translational research of novel cancer therapeutics that leverage . ... [ click link below for full article]

BEDFORD, Texas, July 19, 2021 /PRNewswire/ -- Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for treatment of retinal degenerative diseases, today announced that the first patient had been dosed in its Phase 2b clinical trial of MCO-010, an ambient-light activatable optogenetic monotherapy to restore vision in patients with retinitis pigmentosa (RP).e. ... [ click link below for full article]

Meanwhile, Texas-based biotech company Nanoscope Therapeutics is expected to begin a clinical trial of an opsin that responds to ambient light this summer. Nanoscope’s synthetic opsin molecule responds to a broad range of wavelengths, and the patients don’t require goggles, says Samarendra Mohanty, president of Nanoscope. 

In Nanoscope’s previous trial, conducted in India, 11 patients regained some vision beginning 4-6 weeks after receiving the injections, Mohanty says. Those gains have persisted for one year so far, he says. Some of the patients reportedly see well enough to use a cell phone, read large letters, and travel unassisted to the study center. ... [ click link below for full article]

CAGE Bio Inc., a biotechnology company focused on developing innovative therapies for infection, inflammation and immunology, announced dosing of the first patient in its Phase 2 clinical trial for the treatment of inflammatory lesions of rosacea.

The 12-week randomized double-blind vehicle-controlled trial is testing CAGE Bio's novel ionic-liquid based product CGB-400 Topical Gel. Patients diagnosed with moderate to severe rosacea with inflammatory lesions on their face will be enrolled in the study at four sites in the US and randomized to an active or vehicle arm.

 ... [ click link below for full article]

- With no currently approved therapies for the prevention or treatment of platinum-induced toxicity, RBT-3 has the potential to fill a critical unmet medical need.

Dallas, Texas, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Renibus Therapeutics, Inc., a clinical-stage biotech company focusing on the prevention, treatment, and diagnostic testing of kidney disease, announced today the publication of a peer-reviewed article in the scientific journal Nephrology Dialysis Transplant demonstrating that its investigational treatment for iron deficiency anemia, RBT-3, reduces cisplatin-induced kidney toxicity in an experimental preclinical model... [ click link below for full article]

Nanoscope® team conferred Phase II Retinal Organoid Challenge (ROC) award by National Institute of Health

This is the second program based on Nanoscope's Multi-Characteristic Opsin Platform to receive orphan designation. This designation highlights the unmet need for therapy of patients with rare form of inherited macular degeneration.

BEDFORD, Texas, Feb. 2, 2021 /PRNewswire/ -- To meet the advance challenge for generating a physiologically relevant three-dimensional (3D) retinal organoid, Nanoscope researchers® in collaboration with University of Colorado, and Miami University were recently awarded the top prize from the 3D-ROC challenge by the National Institute of Health (NIH).... [ click link below for full article]

Nanoscope Therapeutics Receives Orphan Drug Designation for gene therapy of blindness

This is the second program based on Nanoscope's Multi-Characteristic Opsin Platform to receive orphan designation. This designation highlights the unmet need for therapy of patients with rare form of inherited macular degeneration.

BEDFORD, Texas, Jan. 25, 2021 /PRNewswire/ -- NANOSCOPE THERAPEUTICS Inc., a clinical-stage biotechnology company determined to change lives through the ocular gene therapy, today announced that it has received an Orphan drug designation from FDA for gene therapy-based treatment of Stargardt disease, a form of inherited retinal degenerative disease caused by gene mutation and passed on to children.... [ click link below for full article]

Scientists use gene therapy and a novel light-sensing protein to restore vision in mice

NIH-funded therapy will now be tested in humans.

October 22, 2020 – A newly developed light-sensing protein called the MCO1 opsin restores vision in blind mice when attached to retina bipolar cells using gene therapy. The National Eye Institute, part of the National Institutes of Health, provided a Small Business Innovation Research grant to Nanoscope, LLC for development of MCO1. The company is planning a U.S. clinical trial for later this year....[click link below for full article]

Biotech Startup Discovers Novel Hand Sanitizer for COVID-19, Offering Long-lasting 4+ Hours of Protection

CAGE Bio Inc., today announced discovery of a novel hand sanitizer that offers long-lasting protection from coronavirus and other harmful viruses, bacteria, and fungi.  It kills germs on contact and, unlike common hand sanitizers, provides protection against their transmission for more than four hours after applying to skin.   .... [click link below for full article].

Biotech Startup Announces R&D Collaboration with Major Japanese Drug Delivery Company

SAN CARLOS, Calif., July 7, 2020 /PRNewswire/ -- CAGE Bio Inc. today announced a research and development agreement with Nitto Denko Corporation for a transdermal formulation of undisclosed molecules. The goal of the partnership is to explore the potential for developing therapeutic products at Nitto using CAGE Bio's proprietary deep eutectic ionic liquid technology. Under this agreement, the companies  .... [click link below for full article].

OncoNano Announces Publication of ONM-100 Phase 1 Data in Nature Communication

Publication data suggests ONM-100 was safe and provides preliminary feasibility data for use in resection surgery in 4 diverse tumor types 

SOUTHLAKE, Texas- OncoNano Medicine, Inc. announced today the publication of Phase 1 clinical trial data in Nature Communications featuring OncoNano’s intraoperative tumor imaging product candidate, ONM-100. The study evaluated safety, pharmacokinetics and feasibility of ONM-100 in image-guided surgery, occult tumor detection and visualization of tumor margins in four different cancer types. Following tumor resection, ONM-100 detected residual tumor positive margins in 9 of 9 patients in whom histology confirmed tumor positive margins, and also detected occult lesions in an additional 5 patients whose tumors were undetected by standard of care. ..[click the link below for full article].