FibroBiologics Engages Southern Star Research as CRO in Australia
FibroBiologics (Nasdaq: FBLG) has engaged Southern Star Research as its CRO in Australia to prepare for a Phase 1/2 clinical trial of CYWC628, a treatment for diabetic foot ulcers. This partnership aims to leverage Australia's high-quality clinical trial infrastructure and R&D incentives. CYWC628 is an allogeneic fibroblast cell-based therapy designed to promote wound healing, particularly for difficult-to-treat diabetic foot ulcers.
CEO Pete O'Heeron stated that this engagement is important for establishing FibroBiologics' clinical trial infrastructure in Australia. The company, with 160+ patents issued and pending, focuses on developing therapeutics for chronic diseases using fibroblasts and fibroblast-derived materials.
FibroBiologics (Nasdaq: FBLG) ha affidato a Southern Star Research il ruolo di CRO in Australia per prepararsi a un trial clinico di fase 1/2 per CYWC628, un trattamento per le ulcere del piede diabetico. Questa partnership mira a sfruttare l'alta qualità delle infrastrutture per i trial clinici in Australia e gli incentivi per la R&S. CYWC628 è una terapia a base di fibroblasti allogenici progettata per promuovere la guarigione delle ferite, in particolare per le ulcere del piede diabetico difficili da trattare.
Il CEO Pete O'Heeron ha dichiarato che questo impegno è fondamentale per stabilire l'infrastruttura dei trial clinici di FibroBiologics in Australia. L'azienda, con oltre 160 brevetti emessi e in attesa, si concentra sullo sviluppo di terapeutiche per le malattie croniche utilizzando fibroblasti e materiali derivati dai fibroblasti.
FibroBiologics (Nasdaq: FBLG) ha contratado a Southern Star Research como su CRO en Australia para prepararse para un ensayo clínico de Fase 1/2 de CYWC628, un tratamiento para las úlceras del pie diabético. Esta asociación tiene como objetivo aprovechar la infraestructura de ensayos clínicos de alta calidad y los incentivos de I+D de Australia. CYWC628 es una terapia celular basada en fibroblastos alogénicos diseñada para promover la curación de heridas, especialmente para las úlceras del pie diabético difíciles de tratar.
El CEO Pete O'Heeron declaró que este compromiso es importante para establecer la infraestructura de ensayos clínicos de FibroBiologics en Australia. La compañía, con más de 160 patentes emitidas y pendientes, se centra en desarrollar terapias para enfermedades crónicas utilizando fibroblastos y materiales derivados de fibroblastos.
FibroBiologics (Nasdaq: FBLG)는 호주에서 Southern Star Research를 CRO로 고용했습니다 CYWC628에 대한 1/2상 임상 시험을 준비하기 위함입니다, 당뇨 발 궤양 치료제입니다. 이 파트너십은 호주의 고품질 임상 시험 인프라와 연구개발 인센티브를 활용하는 것을 목표로 합니다. CYWC628은 동종 이식 섬유아세포 기반 요법으로, 특히 치료가 어려운 당뇨발 궤양의 상처 치유를 촉진하도록 설계되었습니다.
CEO인 Pete O'Heeron은 이 계약이 호주에서 FibroBiologics의 임상 시험 인프라를 구축하는 데 중요하다고 밝혔습니다. 160개 이상의 특허가 발행되거나 대기 중인 이 회사는 섬유아세포와 섬유아세포 유래 물질을 사용하여 만성 질환에 대한 치료제를 개발하는 데 중점을 두고 있습니다.
FibroBiologics (Nasdaq: FBLG) a engagé Southern Star Research comme son CRO en Australie pour se préparer à un essai clinique de phase 1/2 pour CYWC628, un traitement pour les ulcères du pied diabétique. Ce partenariat vise à tirer parti de l'infrastructure de haute qualité pour les essais cliniques en Australie et des incitations à la R&D. CYWC628 est une thérapie cellulaire à base de fibroblastes allogéniques conçue pour favoriser la guérison des blessures, en particulier pour les ulcères du pied diabétique difficiles à traiter.
Le PDG Pete O'Heeron a déclaré que cet engagement est essentiel pour établir l'infrastructure des essais cliniques de FibroBiologics en Australie. L'entreprise, qui dispose de plus de 160 brevets émis et en attente, se concentre sur le développement de thérapeutiques pour les maladies chroniques en utilisant des fibroblastes et des matériaux dérivés des fibroblastes.
FibroBiologics (Nasdaq: FBLG) hat Southern Star Research als CRO in Australien engagiert, um sich auf eine Phase 1/2 klinische Studie für CYWC628, eine Behandlung für diabetische Fußgeschwüre, vorzubereiten. Diese Partnerschaft zielt darauf ab, die hochwertige Infrastruktur für klinische Studien in Australien und die Forschungs- und Entwicklungsanreize zu nutzen. CYWC628 ist eine allogene Therapie auf Basis von Fibroblasten, die zur Wundheilung beitragen soll, insbesondere bei schwer zu behandelnden diabetischen Fußgeschwüren.
CEO Pete O'Heeron erklärte, dass dieses Engagement wichtig ist, um die Infrastruktur für klinische Studien von FibroBiologics in Australien aufzubauen. Das Unternehmen, das über mehr als 160 erteilte und angemeldete Patente verfügt, konzentriert sich auf die Entwicklung von Therapien für chronische Krankheiten mit Fibroblasten und fibroblastabgeleiteten Materialien.
- Engagement with Southern Star Research as CRO in Australia for clinical trials
- Preparation for Phase 1/2 clinical trial of CYWC628 for diabetic foot ulcers
- Leveraging Australia's high-quality clinical trial infrastructure and R&D incentives
- 160+ patents issued and pending in fibroblast-based therapeutics
- None.
Insights
FibroBiologics' engagement with Southern Star Research for CRO services in Australia marks a significant step towards advancing their fibroblast cell-based therapy, CYWC628, for diabetic foot ulcers. This move leverages Australia's favorable clinical trial environment, potentially accelerating the development process.
The focus on diabetic foot ulcers is particularly noteworthy, as it addresses a critical unmet medical need. These ulcers are notoriously difficult to treat and can lead to severe complications. CYWC628's mechanism of enhancing fibroblast survival and function in the wound environment could potentially offer a more effective treatment option than current standards of care.
However, investors should note that while promising, CYWC628 is still in early stages. The success of the planned Phase 1/2 trial will be important in determining the therapy's potential and FibroBiologics' future prospects in this field.
FibroBiologics' strategic decision to conduct clinical trials in Australia demonstrates savvy resource allocation. Australia's R&D incentives and streamlined regulatory processes can potentially lead to significant cost savings and faster trial completion, important factors for a clinical-stage biotech company.
The company's robust patent portfolio (160+ patents) suggests a strong intellectual property position, which is vital in the competitive biotech landscape. However, investors should consider that patents don't guarantee commercial success.
The focus on fibroblast-based therapies for chronic diseases positions FibroBiologics in a niche but potentially lucrative market. If successful, their approach could disrupt traditional treatment paradigms for conditions like diabetic foot ulcers. Yet, it's important to remember that many promising therapies fail in clinical trials and FibroBiologics faces the usual risks associated with early-stage biotech companies.
Southern Star Research will provide CRO services for FibroBiologics in Australia
HOUSTON, Sept. 19, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that it has engaged with Southern Star Research to provide clinical research organization (CRO) services for FibroBiologics in Australia. Initial CRO services will include preparatory work for a Phase 1/2 clinical trial utilizing product candidate, CYWC628, to treat diabetic foot ulcers.
Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics, said, "This engagement is an important step forward in creating the infrastructure for FibroBiologics to conduct clinical trials in Australia, including a planned Phase 1/2 clinical trial for CYWC628 to treat diabetic foot ulcers. We look forward to working with Southern Star Research to advance our fibroblast cell-based therapy. Australia offers an attractive destination for clinical trials due to its high-quality clinical trial infrastructure, regulatory environment and R&D incentives. We are confident that Southern Star Research will be a valuable partner in helping us achieve our clinical and regulatory milestones.”
“We are delighted to partner with FibroBiologics, a pioneer in the field of fibroblast cell-based therapies, to support their clinical development in Australia," said David Lloyd, Managing Director of Southern Star Research. "We have extensive experience and expertise in conducting clinical trials across various therapeutic areas and indications, and we look forward to applying our skills and knowledge to this innovative and potentially life-changing therapy for diabetic foot ulcers.”
FibroBiologics' CYWC628 is an allogeneic fibroblast cell-based therapy designed to promote and accelerate wound healing, particularly targeting diabetic foot ulcers that are difficult to treat and may result in infections that increase the risk of hospitalization, amputation, and death. CYWC628 enhances the ability of fibroblasts to survive and function in the wound environment, improving the body's natural repair mechanisms and potentially offering a more effective treatment for chronic wounds.
For more information, please visit FibroBiologics' website or email FibroBiologics at: info@fibrobiologics.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning CRO services to be provided under the master services agreement with Southern Star Research, expected research targets and indications of interest, plans for, and the timing of, clinical trials, and our relationship with Southern Star Research. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) FibroBiologics' ability to maintain the master services agreement with Southern Star Research; (b) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (c) expectations regarding the initiation, progress and expected results of R&D efforts and preclinical and clinical studies; and (d) the unpredictable relationship between R&D and preclinical results and clinical study results. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations.
About Southern Star Research
Founded in 2010 and headquartered in Sydney, Australia, Southern Star Research is a full-service CRO helping sponsors to navigate the complexities of bringing new medical products to market across the Asia Pacific region. Since commencing operations in Sydney, Southern Star Research has grown to become an international team of specialists, managing studies across the globe.
With a focus on the biotechnology and medical device industries, Southern Star Research offers flexible and bespoke solutions that meet the unique needs of each project. Southern Star Research are early phase specialists (Ph 1 and 2), with particular expertise in designing and managing clinical trials that ensure our Clients’ asset is ready for larger Ph 3 and 4 studies, licensing, partnering and acquisition. For more information, visit www.southernstarresearch.com
About FibroBiologics
Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 160+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit www.FibroBiologics.com.
General Inquiries:
info@fibrobiologics.com
Investor Relations:
Nic Johnson
Russo Partners
212-845-4242
fibrobiologicsIR@russopr.com
Media Contact:
Liz Phillips
Russo Partners
(347) 956-7697
Elizabeth.phillips@russopartnersllc.com
FAQ
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