Gabrielson Mechanism Study
Recent work under the directorship of Dr. Edward Gabrielson at Johns Hopkins University showed KLTi inhibits Protein Kinase C signaling, preventing NFκB activation, with resulting inhibition of COX-2 expression and of MMP-9. NFκB activation is also associated with up-regulation of IL-1, IL-6, and TNF-α, all reported to be mediators of the CACS syndrome. Finally, recent unpublished work at Johns Hopkins suggest that KLTi is not only synergistic, in vitro, with inhibitors of fatty acid synthase (FAS), but that it is itself a FAS inhibitor.
Clinical Trial of Kanglaite Injection (KLTi) for Pancreatic Cancer
In the U.S., a phase II clinical trial was just completed in 2014 in which Kanglaite Injection (KLTi), was tested in patients with advanced pancreatic cancer to determine if KLTi plus standard chemotherapy with gemcitabine is superior to treatment with gemcitabine only. Promising preliminary data from two different clinical trials evaluating KLTi plus gemcitabine for pancreatic cancer were published by the American Society of Clinical Oncology (ASCO) at http://meetinglibrary.asco.org/content/78179-102 and http://abstracts2.asco.org/AbstView_132_115489.html. Early published clinical trial data show promising effects when KLTi is combined with gemcitabine for advanced pancreatic cancer.
In Cohort 1 from the Phase 2b study, a total of 41 patients were randomized in a 2:1 scheme and completed treatment: 26 received KLTi plus gemcitabine, 12 received gemcitabine only, and 3 received no treatment. The KLTi plus gemcitabine group had a median PFS of 114 days, significantly longer than the median PFS of 57.5 days in the gemcitabine only group (HR 0.331, 95% CI: 0.141, 0.778, p=0.008). The median survival for KLTi plus gemcitabine was 218 days versus 162 days for the gemcitabine only group. In the Efficacy Evaluable population, the overall response rates were 18.2% (4/22) and 11.1% (1/9) for KLTi plus gemcitabine and gemcitabine only, respectively.
Clinical Trial of Kanglaite Gel Cap (KLTc) for Prostate Cancer
Although there are some clear cut clinical presentations wherein additional radiation therapy or other accepted approaches such as androgen depletion therapy are indicated, a rise in prostate specific antigen after local therapy for prostate cancer can still present as a therapeutic dilemma for oncologists. Currently there are limited therapeutic options that can delay disease progression or improve survival in this subset of patients. The primary objective of the study in patients with a previous history of prostate cancer is to evaluate the effects and safety of two different oral doses of KLTc on prostate specific antigen doubling time (PSADT) in men who have a rising PSA after initial therapy for localized prostate cancer during 12 months of study period.
For More Information
To learn more about KangLaiTe-USA’s clinical trial for KLTi, please visit http://www.clinicaltrials.gov/ct2/show/NCT00733850?term=Kanglaite+pancreatic+cancer&rank=1
To learn about KangLaiTe USA’s clinical trial for patients with a prior history of prostate cancer and a rising PSA, please visit http://www.clinicaltrials.gov/ct2/show/NCT01483586?term=kanglaite+gel+cap&rank=1
If you are interested in learning more about the trial or potentially partnering in KangLaiTe-USA’s efforts, please email .