The role of sex as a biological variable in the efficacy and toxicity of therapeutic nanomedicine

Sharifi, Shahriar; Caracciolo, Giulio; Pozzi, Daniela; Digiacomo, Luca; Swann, Jennifer M.

doi:10.1016/j.addr.2021.04.028

Cited by 22 publications

(11 citation statements)

References 121 publications

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“…This study could ultimately lead to the development of novel and efficient therapeutic wound healing patches that restore the body’s natural healing process by reducing biofilm infections and adjusting the impaired angiogenesis and inflammation at the wound site. As recent reports revealed the critical role of sex in the safety and therapeutic efficacy of nanostructured materials, − further evaluations on the role of sex on the safety and efficacy of wound dressing consisting of nanomaterials are essential. Overall, the patch will substantially increase the likelihood of clinically relevant wound healing and minimize the risk of amputation in patients with chronic wounds.…”

Section: Resultsmentioning

confidence: 99%

Restoring Endogenous Repair Mechanisms to Heal Chronic Wounds with a Multifunctional Wound Dressing

et al. 2021

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Current treatment of chronic wounds has been critically limited by various factors, including bacterial infection, biofilm formation, impaired angiogenesis, and prolonged inflammation. Addressing these challenges, we developed a multifunctional wound dressing-based three-pronged approach for accelerating wound healing. The multifunctional wound dressing, composed of nanofibers, functional nanoparticles, natural biopolymers, and selected protein and peptide, can target multiple endogenous repair mechanisms and represents a promising alternative to current wound healing products.

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Section: Resultsmentioning

confidence: 99%

Restoring Endogenous Repair Mechanisms to Heal Chronic Wounds with a Multifunctional Wound Dressing

et al. 2021

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“…Influence of individuals’ biological variability and integrating end-user perspective for better acceptability : Factors such as gender and physiological or anatomical differences may influence the PK, drug release kinetics, and therapeutic efficacy of LA products [ 144 , 145 ]. The HPTN 077 study showed that the LA CAB half-life was significantly longer in females compared to males and influenced by body mass index [ 29 ].…”

Section: Roadmap Of La Hiv Prevention Product Developmentmentioning

confidence: 99%

Long-acting HIV pre-exposure prophylaxis (PrEP) approaches: recent advances, emerging technologies, and development challenges

Agrahari

Anderson

Peet

et al. 2022

Expert Opinion on Drug Delivery

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Introduction: Poor or inconsistent adherence to daily oral pre-exposure prophylaxis (PrEP) has emerged as a key barrier to effective HIV prevention. The advent of potent long-acting (LA) antiretrovirals (ARVs) in conjunction with advances in controlled release technologies has enabled LA ARV drug delivery systems (DDS) capable of providing extended dosing intervals and overcome the challenge of suboptimal drug adherence with daily oral dosing. Areas covered: This review discusses the current state of the LA PrEP field, recent advances, and emerging technologies, including ARV prodrug modifications and new DDS. Technological challenges, knowledge gaps, preclinical testing considerations, and future directions important in the context of clinical translation and implementation of LA HIV PrEP are discussed. Expert opinion: The HIV prevention field is evolving faster than ever and the bar for developing next-generation LA HIV prevention options continues to rise. The requirements for viable LA PrEP products to be implemented in resource-limited settings are challenging, necessitating proactive consideration and product modifications during the design and testing of promising new candidates. If successfully translated, next-generation LA PrEP that are safe, affordable, highly effective, and accepted by both end-users and key stakeholders will offer significant potential to curb the HIV pandemic.

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“…Previous reviews in the field have shed some light on how biological sex is considered in clinical trials of nanomedicine and their design, [ 49 ] and provide a detailed comparison between male and female differences at a molecular level. [ 50 ] Here, we address the main findings that are reported in the literature regarding sex differences in nanomedicine and derive conclusions based on pooling all the available data together.…”

Section: Introductionmentioning

confidence: 99%

Sex‐Based Differences in the Biodistribution of Nanoparticles and Their Effect on Hormonal, Immune, and Metabolic Function

Poley

Chen

Sharf-Pauker

et al. 2022

Advanced NanoBiomed Research

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Males and females respond differently to medications due to physiologic, metabolic, and genetic factors. At times, sex‐related differences cannot be mitigated by dose adjustment to body mass, and are evident from the tissue level to the single cell. The rising number of clinically approved nanotechnologies calls for assessing how their activity is affected by the patient's sex. Herein, sex differences in nanotechnology are scoped, with emphasis on molecular considerations. Sex‐specific pharmacokinetics of nanocarriers is influenced by the nanoparticle's composition, its size, and architecture. The biodistribution and immune response to nanoparticles in males and females, and the influence nanoparticles have on hormones, fertility, and toxicity, are discussed. Despite its importance, the effect of sex on the design and implementation of nanomedicines is underresearched. Herein, it is aimed to raise awareness of sex differences in the preclinical and clinical evaluation of nanotechnologies.

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The role of sex as a biological variable in the efficacy and toxicity of therapeutic nanomedicine

Cited by 22 publications

References 121 publications

Restoring Endogenous Repair Mechanisms to Heal Chronic Wounds with a Multifunctional Wound Dressing

Restoring Endogenous Repair Mechanisms to Heal Chronic Wounds with a Multifunctional Wound Dressing

Long-acting HIV pre-exposure prophylaxis (PrEP) approaches: recent advances, emerging technologies, and development challenges

Sex‐Based Differences in the Biodistribution of Nanoparticles and Their Effect on Hormonal, Immune, and Metabolic Function

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