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Clinical Trial News

XyloCor Therapeutics Initiates Phase 2b Trial for Gene Therapy XC001 in Refractory Angina

  • XyloCor Therapeutics has dosed the first patient in its Phase 2b EXACT-2 trial evaluating XC001, an adenoviral vector-based gene therapy encoding VEGF for refractory angina treatment.
  • The trial will enroll 100 patients with refractory angina to assess the safety and efficacy of one-time gene therapy delivered via the novel Extroducer® Infusion Catheter System.
  • XC001 previously demonstrated compelling efficacy and safety results in the EXACT-1 Phase 1/2 trial, with 43% of patients reporting no chest pain at six months compared to 93% entering with severe chest pain.
  • The percutaneous administration approach eliminates the need for surgical delivery while achieving higher local gene expression in the heart with minimized systemic side effects.

Quince Therapeutics Strengthens Scientific Advisory Board with Leading Immunologist Ahead of Phase 3 Results

Rare Disease
  • Quince Therapeutics appointed Dr. Hassan Abolhassani, a top-cited immunologist from Karolinska Institutet, to its Scientific Advisory Board as the ninth expert member.
  • The appointment comes as the company prepares to report topline results from its pivotal Phase 3 trial of eDSP for Ataxia-Telangiectasia in Q1 2026.
  • Dr. Abolhassani brings specialized expertise in immunodeficiency disorders and Ataxia-Telangiectasia, supporting Quince's expansion into multiple rare disease indications.
  • The company is exploring eDSP for 11 additional rare diseases where corticosteroid treatment could be beneficial without safety concerns.

Federal Circuit Reverses PTAB Decision on Brimonidine Eye Redness Patent in Landmark Claim Construction Ruling

  • The Federal Circuit reversed the Patent Trial and Appeal Board's claim construction of U.S. Patent No. 8,293,742, which covers methods for reducing eye redness using brimonidine as the sole active ingredient.
  • The court ruled that prosecution history can alter conventional patent claim language meanings, establishing that "consisting essentially of" in this context precludes the use of any active agents other than brimonidine.
  • Eye Therapies successfully defended their patent against Slayback Pharma's challenge by demonstrating that their prosecution arguments created a more restrictive interpretation than the phrase's traditional meaning.
  • The precedential decision emphasizes the significant impact prosecution history can have on post-issuance patent claim construction and validity determinations.

Five New York Cancer Centers Form Empire State Cellular Therapy Consortium to Accelerate Cell and Gene Therapy Development

  • Five major New York research institutions have established the Empire State Cellular Therapy Consortium to accelerate cell and gene therapy development and expand patient access to innovative treatments.
  • The consortium provides members access to Roswell Park's $98 million GMP Engineering & Cell Manufacturing Facility, featuring 20 clean rooms and backed by $50 million in state and foundation funding.
  • Clinical trials are expected to launch within the next two years, with the consortium aiming to expand cell therapies beyond blood cancers to solid tumors and chronic diseases like multiple sclerosis, lupus, and diabetes.
  • The partnership will enhance access to FDA-approved standard-of-care cell therapies and enable participation in clinical trials across all member facilities.

Cannabinoid Drug Development Accelerates with 50+ Companies Advancing Clinical Trials

  • DelveInsight reports over 50 pharmaceutical companies are actively developing 55+ cannabinoid therapies across various clinical stages, representing significant momentum in the therapeutic cannabis space.
  • Recent clinical milestones include positive Phase II results for IGC-AD1 in Alzheimer's agitation, FDA orphan drug designation for BRC-002 in complex regional pain syndrome, and successful Phase I completion for OCT461201.
  • Leading pipeline candidates target diverse conditions including neurodegenerative diseases, chronic pain, epilepsy, and inflammatory disorders, with multiple drugs advancing through Phase II and Phase III trials.
  • The expanding pipeline reflects growing clinical validation for cannabinoids in treating conditions like Alzheimer's disease, chronic pain, and rare epilepsy syndromes, supported by increasing medical cannabis legalization.

Novartis Secures Canadian Public Reimbursement for Cosentyx in Hidradenitis Suppurativa

Monoclonal Antibody
  • Novartis successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance for public reimbursement of Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa.
  • Quebec becomes the first Canadian province to provide public reimbursement for Cosentyx in hidradenitis suppurativa, marking an important milestone for patient access.
  • The agreement addresses a significant unmet medical need for patients with this chronic, painful inflammatory skin condition who have historically had limited treatment options.
  • Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A and has been studied clinically for more than 14 years.

AstraZeneca Conducts Real-World Safety Study for Anticoagulation Reversal Agent Ondexxya

Real World Evidence
  • AstraZeneca is conducting an observational cohort study titled "Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation" to assess the safety and effectiveness of their anticoagulation reversal agent in real-world settings.
  • The prospective study, which began on June 2, 2022, focuses on detecting unknown adverse reactions and understanding factors affecting Ondexxya's safety and efficacy under actual use conditions.
  • Ondexxya is an intravenous injection used to reverse anticoagulation effects in patients, representing AstraZeneca's commitment to drug safety in the anticoagulation reversal market.
  • The ongoing study could potentially enhance investor confidence and impact competitors in the anticoagulation reversal market if results demonstrate positive safety and effectiveness outcomes.

Alvotech Appoints Linda Jónsdóttir as Chief Financial Officer

  • Alvotech, a global biosimilar medicines company, has appointed Linda Jónsdóttir as Chief Financial Officer, bringing 15 years of senior leadership experience from Marel food processing technology company.
  • Joel Morales, who served as CFO since 2020 and helped transform Alvotech from a private R&D-focused company to a profitable public biosimilars leader, is stepping down to prioritize family time.
  • Jónsdóttir's appointment comes as Alvotech continues its rapid growth trajectory with two approved biosimilars already marketed globally and nine additional candidates in development pipeline.

Pelthos Therapeutics Launches ZELSUVMI, First FDA-Approved At-Home Treatment for Molluscum Contagiosum

Drug Approval
  • Pelthos Therapeutics has commercially launched ZELSUVMI (berdazimer) topical gel 10.3%, the first FDA-approved prescription medication for molluscum contagiosum that can be applied at home by patients or caregivers.
  • The nitric oxide-releasing gel demonstrated significant efficacy in the largest Phase 3 molluscum study to date, achieving complete lesion clearance in 33% of patients versus 19.7% with placebo at 12 weeks.
  • Molluscum contagiosum affects an estimated 16.7 million Americans with up to 6 million new cases annually, yet up to 73% of pediatric cases go untreated due to limited therapeutic options and inconvenient procedural treatments.

A Phase 3 Molluscum Contagiosum Efficacy and Safety Study

NCT04535531CompletedPhase 3
Novan, Inc.
Posted 9/1/2020

Dymicron's Diamond-Based Cervical Disc Receives FDA Approval to Begin U.S. Clinical Trial

  • Dymicron received FDA Investigational Device Exemption (IDE) approval to begin a pivotal clinical trial of its Triadyme-C cervical artificial disc for degenerative disc disease treatment.
  • The device features proprietary Adymite polycrystalline diamond bearing surfaces designed to dramatically reduce wear debris generation compared to conventional implant materials.
  • The multi-center trial will compare Triadyme-C to anterior cervical discectomy and fusion surgery, with first implantations expected in Q4 2025.
  • The tri-lobed design is engineered to closely replicate normal spinal kinematics, potentially improving long-term patient outcomes.

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