今天看到国外一个关于唇疱疹的药物的新闻,转过来给大家看一下.
NanoBio successfully completes phase 2b study in Herpes labialisPublished: Tuesday, 18-Mar-2008
NanoBioCorporation reported top-level findings from its phase 2b study ofNB-001, a topical lotion to treat herpes labialis (cold sores).The randomized, double-blind, vehicle- controlled study met itsprimary and secondary endpoints by demonstrating clear efficacy andsafety in 482 patients.(在482个患者上证明完全有效与安全)
NanoBio's uniquely formulated lotion resulted in faster healing ofcold sores, at a rate never seen before by a topical product. Thecompany's targeted phase 3 dose demonstrated highly statisticallysignificant clinical efficacy in phase 2b at a magnitude comparablewith or superior to what has been reported for the leading oral(systemic) anti-herpetic drugs on the market today.
Additionally, NB-001 demonstrated an excellent safety profile, withno serious adverse events, significant skin irritation or systemicblood absorption. In contrast, leading oral systemic treatments forherpes labialis carry label warnings that include nausea, diarrhea,vomiting, rash and migraine.
"Through this trial, we have confirmed that NB-001 achieves theefficacy of leading systemic treatments without presenting safety, druginteraction or toxicity risks," said James R. Baker Jr., MD, founderand chairman of NanoBio Corporation. "Based on the data, NanoBio willmove immediately to initiate plans to begin phase 3 testing of NB-001in early 2009." The full data set from the phase 2b study will bepresented following a standard peer review process.
NB-001 is a proprietary oil-in-water emulsion composed ofnanometer-sized droplets that employ a physical process to disrupt theouter lipid membrane of viruses. The droplets traverse the pores andhair follicles of the skin without disrupting normal tissues. Thesedroplets accumulate in the epidermis and dermis where they interactdirectly with and kill the viral organisms at the site of infection.
"The product's novel mechanism leaves little risk of drugresistance, which is a concern with the systemic antiviral therapiesused to treat herpes labialis," said Baker. "This attribute coupledwith its safety profile may eventually allow NB-001 to be sold withouta prescription. This will be important to those people affected by thisdisease, since the vast majority of herpes labialis sufferers todayseek over-the-counter treatments for their cold sores."
NanoBio's pipeline of topical anti-infective products and nasallydelivered vaccines are based on the company's novel NanoStattechnology, a platform protected by five issued patents, as well asnumerous pending filings. The issued patents provide patent protectionthrough 2019, while pending filings would extend protection through2029.
http://www.nanobio.com/
nanobia 这个公司研究的nb-001这种药物已经进入第二阶段的实验.大意是说他们的这种洗剂(lotion)对治疗辱疱疹(HSV-1)完全有效,并且没有复发.
没有看得很仔细!