FDA Approves Phase I Study Design for Cellceutix's Anti-Cancer Drug Kevetrin
Biopharmaceutical firm Cellceutix announced this week that the US Food and Drug Administration has green-lighted the protocol for a proposed Phase I study for the investigational cancer drug Kevetrin.
Kevetrin, the company's lead compound, has shown activity across multiple xenograft models, including lung, breast, colon, and prostate cancers; squamous cell carcinoma; and a leukemia tumor model. Early data suggests the drug may be able to affect both wild-type and mutant p53, the tumor suppressor protein that plays a critical role in maintaining the cellular and genetic stability needed to ward off mutations that lead to cancer.
The company estimates that p53 mutations compromise the protein's protective function in more than 50 percent of cancers. According to Cellceutix, more than 10 million cancer patients have tumors with inactive p53 proteins and about as many people harbor tumors with other signaling components inactivated that in turn partially compromise the p53 pathway.
"This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function, which Kevetrin appears to be doing the majority of the time," the company said in a statement. Cellceutix believes that early in vivo and in vitro data show that Kevetrin might be particularly efficacious in attacking drug-resistant cancers.
The Phase I study will be conducted at Harvard Cancer Center's Dana-Farber Cancer Institute. Researchers from Beth Israel Deaconess Medical Center will also take part in conducting the trial. An Institutional Review Board has approved the protocol for the study.
Labceutics Launches Personalized Rx Lab Network in EU
Labceutics earlier this month launched its Labceutics Connect platform, a secure portal through which lab industry professionals in the European Union can share information about best practices and partner around opportunities to advance personalized medicine.
"The platform will also provide members with the ability to introduce new and innovative personalized medicine tests and technologies within the network," Labceutics said in a statement.
Labceutics, a subsidiary of personalized medicine-focused consultancy Diaceutics, has partnerships with more than 120 labs in the EU in an effort to create a network that drug and diagnostic firms can use to connect with the lab industry and facilitate better adoption of personalized drugs.
In addition to labs, Labceutics is also trying to bring into its network other personalized medicine-focused associations, biobanks, and drug and test makers.
Labceutics will demonstrate Labceutics Connect and provide information about the network at its booth at the ESMO Congress meeting in Vienna Sept. 28 - Oct. 2. The company is planning to launch a similar lab network in Asia.