Bolk Drug(Coix Seed Oil For Injoection); Soft Capsules
(Click following titles for corresponding clinical report)
A. Pharmacology/ Pharmacodynamic Studies
B. Pharmacokinetic Studies
C. Toxicology Studies
D. Mechanistic Studies
D. Mechanistic Studies
(Click following titles for corresponding clinical report)
A. KLT Application in the Treatment of Non-Small Cell Lung Cancer (NSCLC)
B. KLT Application in the Treatment of Primary Hepatic Cancer
C. KLT Application in the Treatment of Non Hodgkin's Lymphoma (NHL)
D. KLT Application in the Treatment of Other Tumors
E. KLT Application in the Treatment of Cancerous Pain
F. KLT Application in the Treatment of Ascites
90 FAQs on Anticancer Drug Kanglaite® Injection
PART I: BASIC FACT & CLINICAL DIRECTION
Q1. What is KLT?
A: With its active ingredient extracted from seed of “semen coicis”, a natural anti-tumor herbal plant, Kanglaite Injection (KLT) is a novel dual-function, broad spectrum and molecular-targeting anti-neoplastic formulation for intravenous and intra-arterial application. KLT can directly inhibit and kill cells of various tumors, control lesions, and prevent metastasis. Simultaneously it is able to protect normal cells and improve immune function. In addition KLT presents significant role in relieving cancerous pain and cachexia and improving clinical symptoms so as to upgrade patient quality of life and prolong survival. KLT can be used alone or combined with chemotherapy or radiation therapy or applied peri-operationally. The combination therapy is able to remarkably enhance effect of chemotherapy or radiotherapy, prevent and minimize toxic side effect of these therapies and raise resection rate in operation. Therefore KLT is an ideal anticancer drug.
Q2. In which country is KLT manufactured?
A: In P. R. China by Zhejiang Kanglaite Pharmaceutical Co., Ltd.
Q3. Is KLT a botanical anticancer drug?
A: Yes. Its active substance comes from seed of a herb “semen coicis”.
Q4. Is KLT a TCM or a western medicine?
A: KLT is a botanical anticancer drug developed and manufactured on the basis of international criteria of western medicine.
Q5. Who invented KLT?
A: Mr. LI Dapeng, Professor of Zhejiang Provincial TCM University and President of Zhejiang Kanglaite Pharmaceutical Co., Ltd. He is also academician of China Engineering Academy and Russian Academy of Medical Sciences.
Q6. In which countries is KLT patented?
A: So far KLT has obtained patent certificates from 11 countries and regions i.e. China, USA, EU, Canada, Japan, Korea, Russia, Phillipines, Indonesia, India and Hong Kong.
Q7. When did KLT respectively get new drug registration certificate in China and Russia?
A: In 1995 and 2003.
Q8. How many Chinese cancer patients have used KLT so far (up to the end of 2011)?
A: Over 650,000 Chinese patients have got benefit from KLT.
Q9. What are “double-phase” and “broad spectrum”?
A: “Double-phase” refers to direct killing of tumor cells while improving body immune function and “broad spectrum” means that different kinds of tumors are quickly responded to KLT treatment with satisfactory therapeutic effect.
Q10. Was KLT registered as a new drug or as herbal remedy in China and Russia?
A: In China and Russia KLT is registered as new drug although its active ingredient derives from herb. KLT will also be approved as an anticancer new drug since active substance, molecular structure, anticancer mechanism at molecular level, clinical efficacy and safety have been scientifically defined, extensively studied, carefully evaluated and strictly examined before approval. Its R&D, preclinical and clinical studies have met with strict requirements and standards of a Western new drug.
Q11. What caterogy was KLT applied for registration at FDA, USA?
A: At FDA, application of KLT was on botanical caterigy and currently a phase II study is being conducted in USA.
Q12. In which sountries has KLT started registration application, in addition to USA and Russia?
A: Philippines, Brazil, GCC organization, Saudi Arabia, and Yemen.
Q13. Is KLT a prescription drug and where can I apply it?
A: Yes, it is a prescription drug. Patient has to apply KLT with doctor prescription and in a hospital.
Q14. What are the major indications of KLT?
A: Various stages primary lung cancer including NSCLC, primary hepatic cancer, pancreatic cancer and lymphoma. KLT has satisfactory therapeutic effect on various advanced tumors in palliative treatment in addition to its unique effect on cachexia and cancerous pain.
Q15. What is the active substance in KLT?
A: It is coix triglyceride that is already patented in 11 countries and regions in the world.
Q16. What are other ingredients in addition to coix oil in KLT?
A: KLT contains injection grade soybean phospholipid and glycerin. Soybean phospholipid plays a role as emulsifier and dispersing agent while glycerin is an isotone regulating agent.
Q17. What is composition of KLT?
A: In 100 ml: injective coix oil 10g, soybean phospholipid 1.5g, glycerin 2.5g and injective water.
Q18. What is standard treatment dosage and cycles of KLT?
A: Standard dosage: 200ml (2 bottles) per day, i.v. drip for 21 days as 1 cycle (42 bottles). The second cycle starts after 5-7 days of rest. A standard course includes 2 cycles (84 bottles). Optional treatment protocol: 200ml (2 bottles) Monday-Friday, i.v., rest on Saturday and Sunday, repeat next Monday-Friday, 4 weeks as a cycle (40 bottles), then rest for a week before the second cycle. A standard course includes 2 cycles (80 bottles). Patient could administrate KLT on the basis of personal actual situation.
Q19. How many cycles should a patient have for good effect?
A: Based on actual condition 1 treatment course (84 bottles) is recommended for patients after surgical operation. In case of KLT combined with chemotherapy or radiotherapy, a patients can consider to use 1-2 courses (84-168 bottles). For advanced stage patients, 2-3 courses (168-252 bottles) are necessary for good efficacy.
Q20. Why does a patient need 3-5 days interval between the two treatment cycles?
A: An interval of 3-5 days helps reduce fat metabolic load and minimize side effect.
Q21. Is there any relation between treatment course and therapeutic effect?
A: Clinical studies have verified a direct relation between the two. That is also a basis for our recommended dosage to reach better therapeutic effect, stabilized symptoms and longer life with quality.
Q22. Can KLT be used 1 bottle in the morning and 1 in the late afternoon for better effect?
A: Not necessary. 2 bottles at a time will give effect.
Q23. Does infused volume have direct relation with therapeutic effect?
A: Preclinical experiments showed that there was volume-effect relation expressed in cancer inhibition rate. the bigger the infused volume, the higher the therapeutic effect and vice versa.
Q24. What is daily maximum safety dosage of KLT for optimum effect?
A: KLT pharmacodynamic study discovered its volume-effect relation. The bigger the infused volume, the better the effect. 200ml are standard daily dosage. However in phase I trial in USA in 2001, maximum daily dosage of KLT reached 500ml for consecutive 120 days without any apparent adverse reaction.
Q25. Could KLT be applied on long-term basis?
A: So long as clinical indication and affordability are met, KLT can be applied for a long time without serious toxic and side reaction due to its botanical nature. During application, variation in liver-enzyme should be monitored and tested accordingly.
Q26. How long is validity of KLT?
A: 18 months from the date of production.
Q27. Please introduce packaging specification of KLT.
A: 100 ml/bottle, 1 bottle/box, 7 boxes/mid box, 3 mid boxes/carton with gross weight of 6.5 kg
Q28. Does KLT have anti-freezing package?
A: To minimize freezing risk caused by environmental low temperature during drug transportation, KLT is packed in anti-freezing package i.e. an inner plastic foam box is used within a carton to eliminate possibility of freezing during short time. However it can not resist long-time low temperature. Tests demonstrated that it would take about 15hrs 20min to reduce emulsion temperature from 4 °C to 0 °C.
Q29. Does KLT have export package with foreign language?
A: Export package for KLT has English or Russian language including package insert.
Q30. Should KLT be kept in a refrigerator?
A: Absolutaly not! KLT should be kept in a cool and dark place with freezing strictly prohibited since freezing can cause separation of water and oil and makes KLT not applicable.
Q31. Shall KLT be warmed up before administration in winter?
A: In winter KLT can be put into 30°C water before infusion to avoid physical irritation.
Q32. What are the precautions for clinical use of KLT?
A: 1. For first-time application speed should be controlled within 20 drops per minute during the first 10 minutes. Then increase the speed slowly until 40-60 drops after 30 minutes.
2. Carry out symptomatic treatment in case of occasional severe lipid allergy and stop application of KLT.
3. No other medicine can be added into KLT during infusion.
4. During infusion, extra vascular leakage of fluid causing pain shall be prevented. In winter, put bottle in 30°C water to avoid physical irritation.
5. Disposable infusion set with end-filter should be adopted.
6. It is strictly prohibited to apply KLT intravenously in case of delamination (oil-water separation).
7. In case of slight phlebitis, 0.9% sodium chloride or 5% glucose 50-100ml should be used before and after intravenous instillation of KLT.
8. Apply it with caution in case of severe abnormality of hepatic function.
Q33. Can KLT be mixed with other medicine for infusion?
A: Absolutely no.
Q34. Can other infusion start immediately after KLT administration?
A: After KLT administration if the same passage is kept, it is advised that 50-100ml of 0.9% sodium chloride or 5% glucose are infused before applying other infusion.
Q35. Is there any incompatibility in applying KLT?
A: As an emulsive formulation KLT should be used alone. It can be mixed into “all-in-one” TPN with a prerequisite that its incompatibility is fully considered in advance. No glucose fluid, electrolyte solution or other medicines are allowed to add into KLT in order to keep stability of emulsion to avoid any change in electric change or pH value and also to avoid severe fat embolism.
PART II: CLINICAL APPLICATION (combined with chemo/radio therapy, used in perioperation/intervention/palliative treatment)
Q36. What are the clinical benefits of KLT?
A: 1. Mono-therapy of KLT presents similar effect of chemotherapy in terms of lesion control.
2.Mono-therapy of KLT improves survival quality and prolongs life for advanced patient intolerable to or after inefficacious chemotherapy.
3.If combined with chemo or radiation therapy KLT can reduce toxic adverse reaction and enhance therapeutic effect.
4. If combined with surgery KLT can control growth of lesion so as to improve resection rate and minimize risk of post-operative tumor spread and metastasis.
5. KLT presents long-time analgesic effect without addiction in controlling cancerous pain.
6. KLT has no toxic adverse reaction to heart, liver, kidney and hematopoietic function while maintaining its anti-neoplastic therapeutic efficacy.
Q37. What kind of tumor do Chinese cancer patients have when appling KLT?
A: Mainly lung cancer, liver cancer, breast cancer, pancreatic cancer, esophagus cancer, stomach cancer, kidney cancer, colon-rectum cancer, ovarian cancer and and prostate cancer. Malignant lymphoma and leukemia are also included.
Q38. Can KLT be used alone?
A: Yes it can. It has similar effect as those first-line chemotherapy drugs in treating lung and liver cancers. The phase III trial in China has verified this. Moreover, KLT can be used alone in peri-operational period or after inefficacious chemotherapy or in palliative treatment in terminally ill stage to prolong patient life and improve life quality.
Q39. Which tumor responds quality well to KLT?
A: Non-small-cell lung cancer (NSCLC) and primary hepatic carcinoma in various stages.
Q40. What is the clinical benefit of KLT combined with chemotherapeutic drugs?
A: To enhance therapeutic effect of chemotherapy while minimize toxic side effect such as impairment to bone marrow or to function of liver and kidney.
Q41. Which are the chemotherapy regimens suitable to combine with KLT?
A: Lung cancer: MVP, CAP, EP, NP, GC and TP; Lliver cancer: KLT combined with chemo-drug such as DDP, 5-Fu and E-ADM; Pancreatic cancer: 5-Fu and GEM; Breast cancer: CMF, FACT; FAM or ELF, etc.
Q42. What benefit can KLT bring to patients after inefficacious chemotherapy?
A: 1. KLT has unique therapeutic effect on tumors to control growth or spread of tumor.
2. KLT is able to improve patient survival quality, and
3. KLT is able to prolong patient survival period.
Q43. If chemotherapy is combined with KLT, can it help reduce the dosage of chemo-regime?
A: No. Need to maintain normal dosage.
Q44. What is the daily dosage of KLT if combined with chemo or radiation therapy?
A: During combination therapy adult daily dosage of KLT should be 2 bottles (200ml) per day for consecutive 3 weeks as a cycle.
Q45. How is KLT applied in combination with interventional chemotherapy?
A: In interventional treatment of patients with lung, liver or breast cancers, KLT is injected via catheter in bronchial or femoral artery at dosage of 100-200ml/time, once per week, 3 weeks as a cycle together with KLT i.v. 100-200ml per day, 21 days as a cycle for better clinical effect.
Q46. How’s the dosage of KLT to combine with intervention in treating liver or lung cancer?
A: Liver cancer:
1) KLT 100ml is slowly injected via catheter in hepatic artery in 30min. 3 days before intervention KLT 100ml is applied daily via i.v. dripping for 21 days as one cycle. The above treatment is repeated after 6 weeks with 2 cycles in all.
2) Punctured at femoral artery, catheter is selectively retained at proper hepatic artery and patient is in horizontal position in bed for 10 days with regular dressing change at puncturing point. KLT is injected 200ml per day for 10 days. Lung cancer: KLT 100ml is slowly injected via chatheter in bronchial artery in 30min. 3 days before intervention KLT 100ml is applied daily via i.v. dripping for 21 days as a cycle. The above treatment is repeated after 6 weeks with 2 cycles in all.
Q47. Can KLT be locally injected at thoracic cavity?
A: KLT local injection at thoracic cavity can notably eliminate cancerous hydrothorax and pericardial effusion with effective rate as over 80% based on Chinese studies published. Method: After continuous drainage of hydrothorax, KLT100-200ml are combined with chemotherapy drug to be injected into local thoracic cavity once or twice per week. Meanwhile, KLT 100-200ml via intravenous dripping is applied daily with 21 days as a cycle for better therapeutic effect.
Q48. What is the mechanism behind KLT in treating hydrothorax?
A: Local injection of KLT in thoracic cavity can cause local adhesion in pleura so as to reduce exudation of hydrothorax.
Q49. What is the advantage of KLT to combine with radiation therapy?
A: 1. Enhance therapeutic effect by raising gain factor.
2. Protect hematopoiesis of bone marrow and elevate peripheral WBC.
3. Enhance immune function by activating T lymphocytes and NK cells, and
4. Improve survival quality, anorexia, loss of body weight and KPS reduction.
Q50. What is the advantage of KLT in pre-operative use?
A: KLT, in its pre-operative use, can cause liquefaction, necrosis and apoptosis of cancel cells so as to elevate surgical resection rate. In addition KLT prevents spread and metastasis of residual tumor cells by strengthening immune function of patient.
Q51. Can KLT be applied to control post-operative pulmonary infection?
A: Although KLT is not an antibiotic drug it has the function of activating T lymphocytes and NK cells to facilitate synthesis and secretion of interleukin and enhance phagocutic function of macrophage function of hematopoisis. Therefore KLT can improve immune function both specifically and nonspecifically to reduce occurrence of post-operative pulmonary infection.
Q52. What are the clinical benefits of KLT to be used by advanced cancer patients?
A: KLT is able to effectively eliminate patient cachexia state, improve life quality, increase body weight, and prolong patient life.
Q53. Can KLT notably improve patient cachexia?
A: Cancer patients at mid and advanced stages will occur cachexia with big energy consumption. KLT, as an anticancer emulsion, is able to provide high energy to patient to improve cachexia. Its calorie value is 4,906J/g, remarkably higher than that from 10% glucose or intravenous fat emulsion. Phase III study in China revealed that KLT could effectively prevent loss of body weight, increase food intake and prolong patient life. Meanwhile KLT can inhibit tumor growth, cause partial liquefaction and necrosis of tumor cells, regulate cell factor level in serum, and reduce levels of serum TNF-α and IL-1.
Q54. Which are expressed as improvement of KLT in immune function?
A: KLT can activate T-lymphocyte, NK cell and LAK cell, facilitate macrophage to synthesize and secrete interleukin, strengthen phagocutic function of macrophage and hematopoisis. Therefore KLT is able to extensively improve immune function specifically and nonspecifically.
Q55. Can KLT effectively control cancerous pain?
A: Based on phase III study in China, total effective rate of pain control among 328 cases with various tumors was 80.49% after KLT treatment. The response lasted for 1 week after withdrawal of KLT with no addiction. So KLT could partly replace morphine as an analgesic.
Q56. How long will analgesic effect of KLT last?
A: Based on phase III study in China, KLT analgesic effect appeared from 1-3 days after application and pain was gradually alleviated. 96 cases, once used morphine before the treatment, could tolerate morphine reduction and 31 cases accepted morphine withdrawal. The withdrawal rate was 32.29% (31/96).
Q57. Can KLT totally replace parenteral nutrition in treating patient with cachexia?
A: Yes. KLT provides 4,906J/g that is equivalent to 1,200 cal/g.
Q58. Can KLT applied for treating other tumors than NSCLC and primary liver cancer?
A: A large number of published clinical studies in China have proven that KLT has reliable effect in treating breast cancer, pancreatic cancer, colon-rectum cancer, prostate cancer, esophageal cancer, kidney cancer, ovarian cancer, prostate cancer, malignant lymphoma, and leukemia in addition to NSCLC and primary liver cancer.
Q59. Is KLT effective in treating tumor in brain?
A: Currently there is no published clinical study.
Q60. Could KLT be used in treating melanoma?
A: Currently there is no published clinical study to support this although oncologists in Moscow have the intention to carry out such clinical study in Russia.
Q61. What clinical benefit will KLT bring to leukemia patient?
A: Animal experiment showed that KLT could inhibit proliferation of leukemia cells and induce apoptosis. KLT in small dose could reverse MDR of leukemia cells to improve effect of chemotherapeutic drugs in killing cancer cells. Due to toxic side effect of chemotherapy, many patients cannot tolerate continuous treatment with less effectiveness or they have to extend hospitalization so as to increase economic burden. Clinical data showed that KLT in combination with small dose chemotherapy could improve effectiveness with less toxic side effect as compared with mono-chemotherapy. Therefore those patients with longer time of bone marrow inhibition, not suitable for continuous chemotherapy, can consider KLT combination protocol.
Q62. How is therapeutic effect of KLT in treating malignant lymphoma?
A: Based on statistic data from published clinical studies in China, average effective rate of KLT
combined with chemotherapy in the treatment of malignant lymphoma was 82%, about 26%
higher as compared with average therapeutic effect in control groups as only 56%.
PART III: SAFETY & ADVERSE REACTION
Q63. How is clinical safety of KLT?
A: With its active substance extracted from a natural herb semen coicis, KLT is an emulsive formulation manufactured by advanced production line. Following intravenous emulsion techniques from USA, Sweden and Japan, quality standards such as particle size and distribution, pH value, etc. are strictly controlled and compliant to China pharmacopoeia and SFDA requirements. In Beagle dog test at dose of 7.5ml/kg, 15ml/kg and 30ml/kg respectively for 2 consecutive months, there was no toxic side effect or abnormality in liver/kidney function or blood/urine routines. KLT has had no report on severe adverse reaction since launched in China in 1995. In phase I study in USA, no toxic side effect was observed for patients who applied 500 ml daily for continuous 120 days. And this showed high safety of KLT.
Q64. What are contraindications of KLT?
A: KLT is contraindicated in patients with severe lipid metabolic disturbance (acute shock, acute pancreatitis, pathologic hyperlipidemia and lipid nephorosis) and pregnant women.
Q65. Why pregnant women are contraindicated in KLT?
A: Due to ethical reason pregnant women were not enrolled into KLT clinical studies, which lead to lack of necessary clinical data. So they are contraindicated for safety consideration.
Q66. What are adverse reactions of KLT?
A: Occasional allergy to lipid such as shiver, fever, slight nausea and elevation of SGPT, which will naturally disappear after KLT administration for 3-5 days. Slight phlebitis may be occasionally observed.
Q67. How to clinically manage phlebitis caused by applying KLT?
A: When slight phlebitis is observed, 50-100ml 0.9% sodium chloride or 5% glucose shall be infused before and after KLT. Wet dressing with 20-30% magnesium sulfate solution shall be put on the location.
Q68. Can diabetic cancer patient use KLT?
A: Yes, no problem. Based on reports, KLT could stabilize blood sugar level of advanced senile patients. Short period intravenous administration of KLT has no apparent influence on metabolism of blood sugar and blood lipid of cancer patients.
Q69. Can advanced cancer patient with abnormal liver function use KLT?
A: KLT can be applied in case liver function is slightly abnormal and in severe case KLT shall be cautiously used or contraindicated.
Q70. How to treat hyperlipidemia for patient after applying KLT?
A: KLT can continuously be applied in case of transit or slight hyperlipidemia without special clinical management. In severe case, KLT should be stopped, causes for hyperlipidemia shall be found out and relevant treatment shall be conducted. KLT treatment can be restored after normal blood-lipid level.
Q71. How to manage nausea/vomit after partial resection of liver cancer and KLT application?
A: At first it is defined if nausea or vomit is caused by KLT and symptomatic treatment shall be adopted in slight case while KLT application is continued. In a severe case KLT shall be temporarily stopped until causes are found out.
Q72. How to manage fever after KLT combined with interventional treatment via hepatic artery?
A: The fever may be related to the following factors.
(1) Patient is allergic to lipid with shiver, fever or slight nausea and these symptoms will disappear naturally.
(2) Necrotic tumor substance is absorbed by human body and this will cause fever that is normally below 38°C without other malaise. If patient fever is below 38.5°C, only clinical observation is needed and if it exceeds 38.5°C, physical cooling or symptomatic treatment should be conducted after excluding possibilities of infection and other factors.
Q73. Will severe adverse reaction occur after KLT treatment?
A: Quality standard of KLT strictly follows those from USA, Sweden and Japan. Particle size of KLT has been at world top level. “Particle distribution” is an important QC index. Its quality standard approved by USA is that 95% particles should have diameter below 2 μm and particles with diameter bigger than 5 μm should not be detected. In actual test, average particle diameter in KLT is only 0.189μm with maximum diameter as 0.545μm and 90% particles have average diameters between 0.1-0.4μm. So internal QC level is more strict than standard requirement including osmotic pressure, pH value and stability, etc. Hence, adverse reaction like fat embolism will not occur during application of KLT.
PART IV: PRE-CLINICAL STUDY
Q74. What is pharmacological action of KLT?
A: Based on pharmacodynamic studies, KLT presents remarkable inhibitive effect on various human tumor cell strains transplanted while it enhances body immune system. Moreover, it has notable analgesic effect to resist cancerous pain.
Q75. Which internal organs does KLT distribute after application?
A: In study, mice infused with H marked KLT had extensive internal distribution with peak concentration at sites of lung, liver and spleen.
Q76. What are the half-life period and bioavailability of KLT?
A: 15.84 hours and its bioavailability is 100%.
Q77. What are the major anticancer mechanism of KLT?
A: 1. Cell cycle: inhibit cell multiplication and induce apoptosis by blocking number of cells at G2/M phase to enter G0-G1 phases so as to reduce percentage of cells in S phase.
2. Angiogenesis: notably resist growth of newborn vessels
3. Cell-factor: reduce TNF-α and IL-1 levels and elevate IL-6 level to improve cachexia
4. Gene expression: down-regulate bcl-2 and up-regulate P53
5. Cell enzyme: inhibit expression of MMP-9, COX-2, PKC and FAS
6. NFkB: down-regulate expression of NFkB especially in human breast cancer cell strains
Q78. Which tumor-related gene expressions are affected by KLT?
A: Experiments proved that KLT could up-regulate P53 expression and down-regulate Bcl-2 and MUC1 expressions so as to inhibit tumor invasion and metastasis.
Q79. How can KLT reverse MDR (Multi Drug Resistance) of tumor cells?
A: MDR reversion is a mechanism for effect–enhancement of chemotherapeutic medicine if combined with KLT. Experiment on drug-resisting K562/VCR cell strain showed that RMI (Resistance Modification Index) was 42.6 when concentration of KLT reached 2μl/ml. RMI was 45.2 when KLT concentration was 4μl/ml and RMI reached 54.1 in 8μl/ml KLT concentration. This demonstrated that 2-8μl/ml KLT had apparent reversion on tumor cells’ MDR during application of doxorubicin.
Q80. What is the mechanism behind analgesic effect of KLT?
A: Based on accumulated study, the mechanism is closely related to the following. 1). Coix oil could cause reduction of muscle spasm and shorten its fatigue curve to relieve pain. 2). KLT could inhibit tumor growth and induce apoptosis to shrink tumor size thus reducing invasion and press against tissue and nerve. 3). KLT could down-regulate TNF-α and IL-1 expression to prevent and reverse pain allergy by blocking these factors that play important roles in chronic pain or hyperalgia. 4). In rat-tail stimulation test, coixol, an important component in coix seed, presented similar analgesic effect as aminopyrine in strength.
Q81. Where can I find clinical articles on KLT preclinical study?
A: Please visit: http://www.kanglaite.com/BS.htm
PART V. CLINICAL STUDY
Q82. In which countries has KLT been clinically studied?
A: Phase I and II clinical studies have been carried out in USA and Russian Federation respectively and both had inspiring outcomes while phase III trial in China with nearly 1,500 cases also had success. Currently a study on KLT efficacy in treating pancreatic cancer is in progress in USA to be followed by another study on KLT in palliative treatment for advanced cancers at Duke University, USA.
Q83. Will you please briefly introduce KLT phase III study in China?
A: Well, from 1995 and sponsored by Drug Administration Dept., Ministry of Health, KLT phase III trial was conducted in over 30 affiliated hospitals. The trial was divided into 7 protocols with 1,434 cases (not including cases in control groups). Result showed that KLT had remarkable therapeutic effect in both early stage treatment and palliative care for terminally ill patients. The 7 protocols were as follows.
1. KLT treating primary bronchial lung cancer, 305 cases, RR: 12.15 (14.29% in control group);
2. KLT treating primary liver cancer, 156 cases, RR: 11.42 (9.80% in control group);
3. KLT+ chemotherapy to treat NSCLC, 72 cases, RR: 45.00% (21.88% in control group);
4. KLT+ radiotherapy to treat malignant tumors, 190 cases, RR: 82.82% (60.5% in control);
5. KLT+ surgery treating primary lung cancer, 75 cases, RR: 62.22% (26.67% in control);
6. KLT+ intervention treating hepatic cancer, 198 cases, RR: 69.23% (38.24% in control); KLT+ intervention treating lung cancer, 218 cases, RR: 52.11% (28.95% in control group);
7. KLT controls cancerous pain, 328 cases, RR: 80.49; and KLT improve survival quality in palliative treatment, 376 cases, RR: ＞90%
Q84. Could you please tell us KLT phase I trial in USA?
A: Location: Huntsman Cancer Institute (HCI), Utah, USA
Trial leader: Dr. Richard. H. Wheeler (Deputy Director of HCI)
Period: 2001-2002 with follow-up to 2004
Objective: To monitor tolerance and relation between dosage and toxicity/adverse reaction
Total cases: 16 (15 assessable)
Tumor type: 9 categories such as NSCLC, esophagus ca, prostate ca, colon ca, thyroid ca, pancreatic ca, sarcoma, carcinoid and mesothel
Groups: 15 patients in 5 dosage groups, 2-4 cases per group with daily dosage of 100ml (10g), 200ml (20g), 300ml (30g), 400ml (40g) and 500ml (50g)
Evaluation: Among 15 cases SD: (stable disease) 10 cases, PD: (progressive disease) 5 cases
Follow-up: Stability period for 10 SD cases longer than 6 months, Survival for 7 cases exceeding 1 year and 1 pancreatic cancer patient surviving for 25.5
All cases enrolled were with advanced tumors and survival was estimated between 3-6 months.
Conclusion: These data suggest that administration at a dose of 500ml and for 120 days should be equally safe without apparent toxic and adverse reaction.
Stable disease, survival for at least 6 months. All these responses appear to be comparable to those reported from phase III clinical trials in China.
Q85. May I know something about KLT phase II trial in Russia?
A: Location: Russian Cancer Research Center of RAMS and Radiology Research Center of Russian Ministry of Health
Period: 2002-2003, Follow-up to 2005
Purpose: To monitor the efficacy and side effects of KLT in treating NSCLC
Total cases: 25 (22 assessable)
Methods: 1) KLT mono-therapy;
2) Sequential therapy of KLT combined with chemotherapy;
3) KLT combined with chemotherapy
Trial leader: Academician A. M. Garin, Prof. E. K. Voznyi
Conclusion: -72.2% (17/22) patients in KLT monotherapy or sequential chemotherapy got clinical benefit (PR+SD). 40.9% (9/22) patients were still survival in
satisfactory living status with average survival for 352.5 days although they were tumor-loaded.
- 6 cases treated with KLT + GP regimen got 100% effect and TTP was 7.3 months.
Follow-up: 1). 18.8% patients with KLT+EP regimen had their survival reached 43 months (3.5 years). MST was 12.9 months.
2). 83.3% patients with KLT+GP regimen had their survival reached 18 months with MST as 20.6 months.
3). Average MST of patients in 2 groups was 19.8 months as compared with 10 months in the chemotherapy control group.
Q86. Where can I find latest clinical study information in USA?
A: There are two clinical studies in USA since 2008.
- Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer (in progress, see the link below.)
- CACS (Cancer-related Anorexia & Cachexia Syndrome) Trial at Medical Center, Duke University (in 2009, see the link below.)
IMPORTANT WEB LINKS ON KLT STUDIES IN USA (Click following web links for more.)
1) Phase I study of KLT, a botanical product based on traditional Chinese medicine - ASCO, USA
2) Phase I and pharmacokinetic study of KLT, a botanical product based on TCM - ASCO, USA
3) Kanglaite Injection Phase I Study -Clinical trials, USA
4) Safety & Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer -Clinical trials, USA
5) Coix Seed Extract, A Commonly Used Treatment for Cancer in China, Inhibits NFκB and Protein Kinase C Signaling, Prof. Edward Gabrielson, M.D. et al. School of Medicine, Johns Hopkins University, Baltimore, MD. Cancer Biology & Therapy 6:12, 2005-2011, USA
6) KLT application in palliative treatment for advanced cancers in Duke University (DCCC), USA
7) The New Face of Traditional Chinese Medicine by Dennis Normile, “Science”, Vol.299, January, 2003, USA
Q87. Where can I find KLT clinical study information in China, Russia and USA?
A: Please visit: http://www.kanglaite.com/CS.htm
PART IV. OTHERS
Q88. How much is KLT per bottle?
A: Please contact our agent company in your country or send email to us.
Q89. Could you tell me your company’s contact information?
A: Zhejiang Kanglaite Pharmaceutical Co., Ltd.
Add: No. 11 Street, Xiasha Economic and Technical Development Zone, Hangzhou, China
Postal code: 310018
Tel: +86 571 86911888 ext. 1207
Fax: +86 571 86911680
Q90. We wanna be a partner of KLT. What requirement shall our company meet?
A: Please contact us via email and thanks for your interest in KLT product.