Coix is a unique botanically sourced molecular targeted agent prepared as a micro-emulsion for intravenous use. It is manufactured by the state of art technology with active substance extracted from a natural herbal plant “semen coicis”.

COIX has the following features:

1. Killing cancer cells directly and effectively while remarkably improving patient immune function;
2. Synergistic in increasing efficacy and in reducing toxicity when combined with chemotherapy regimens or radiation therapy;
3. Providing high energy nutrition to treat cachexia;
4. Relieving cancerous pain markedly;
5. Improving patient quality of life and notably prolonging survival;
6. With little adverse reaction itself

In Europe, Russia and China COIX is mainly used in the following situation:

1. Combined with chemo regimens to minimize toxic reaction & enhance effect
2. Combined with radiotherapy to improve sensitivity
3. Preoperational monotherapy to prevent further spread and metastasis
4. Monotherapy after inefficacious chemotherapy to elevate KPS, MST and TTP, etc.
5. Treating late stage advanced and metastatic cases to elevate KPS, MST and TTP, etc.
6. Controlling cancerous pain with long lasting effect but without addiction
7. Improving cachexia to provide high energy nutrition
8. Applied in intervention with arterial perfusion in both large and small doses
9. Eliminating hydrothorax and pericardial effusion, etc.

Based on pre-clinical studies at John Hopkins University, USA, tumor-inhibitive rate of COIX on transplanted breast carcinoma induced by cell strain MDA-MB-231 was over 50%. COIX could inhibit the expression of COX2 of the strain in vitro and act as an inhibitor of fatty acid syntheses. The broad ranged basic studies in China also revealed COIX different mechanisms such as inducing cancer cell apoptosis, inhibiting angiogenesis, reversing MDR and regulating gene expression of Fas/Apo-1 and Bcl-2. Both Chinese and overseas clinical experiences have shown that COIX has proven effect in the treatment of cancers mainly at sites of lung, breast, liver, nasopharynx, esophagus, stomach, pancreas, kidney, colon-rectum, ovary and prostate. This agent is also applied in the treatment of malignant lymphoma and acute leukemia. COIX has brought great benefits to over 500,000 cancer patients in more than 2,000 big or medium hospitals in China since 1997.

Standard treatment course for COIX is 200 ml per day via intravenous drip x 42 days. There is a break for 4-5 days after 21 days. And clinical experiences in China and Russia suggest 2 treatment courses for those with late stage advanced and metastatic tumors for better therapeutic effect and evident prolongation of life.

FDA approved COIX clinical study in USA in March 2001 and the phase I study at Huntsman Cancer Institute, Salt Lake City, Utah was satisfactorily completed which laid a solid foundation for forthcoming clinical trials. The US "Science" magazine covered the success of COIX in China and USA in its January issue of 2003.

Russian Federation approved COIX clinical study in January 2002 and the phase II study was smoothly ended in April 2003 with inspiring outcomes. In December 2003 the registration certificate was issued from Russian Ministry of Health and COIX has been marketed in Russia from 2005 with positive response. Currently an international multi-center randomized clinical study on COIX combined with first line chemotherapeutic drugs in the treatment of non-small cell lung cancer (NSCLC) is in progress.


Directions for Use of Coix Injection

PHARMACOLOGY:
Animal experiments showed that Coix Injection has the action of significantly inhibiting the growth of numerous strains of grafted tumor and human tumor cells grafted in nude mice. It can enhance immunologic function and has certain effect of relieving pain as well.

ACTIONS and INDICATIONS:
The preparation has the actions of supplementing Qi and nourishing Yin, eliminating and resolving stagnation and masses. It is used to treat inoperable patients with spleen deficiency and damp-stagnation type of primary non-small-cell lung cancer and primary hepatic cancer. It can be applied in combination with radiotherapy and chemotherapy to improve the therapeutic efficacy.
For patients with mid and advanced malignant tumors, it has the action of improving cachexia and relieving cancer pains.

DOSAGE and ADMINISTRATION:
The usual dosage is 200 ml/day, by slow intravenous infusion, once a day. One therapeutic course lasts 21 days. After one course the patients should have a rest interval of 3-5 days before taking the next course. When combined with chemotherapy or radiotherapy, the dosage of Coix Injection could be reduced accordingly. At the beginning of IV instillation, the drip speed is advisable to be adjusted to 20 drops/min during the first 10 min, which can be continuously increased after 20 min and be controlled to 40-60 drops/min after 30 min.

ADVERSE REACTION:
Occasionally allergy to lipid may occur, e.g. low fewer, shiver and slight nausea. The symptoms usually disappear in 3-5 days after the patients have adapted to Coix Injection. Slight phlebitis may be occasionally noted.

CONTRAINDICATIONS:
The drug is contraindicated in patients with severe lipid metabolic disturbance (patients with acute shock, acute pancreatitis, pathologic hyperlipidemia and lipid nephorosis) and pregnant women.

PRECAUTIONS:

1. If a severe lipid allergic reaction occurs, symptomatic therapy should be given and consequently the use of the drug should be stopped.
2. Other drugs should not be mixed up with Coix Injection.
3. In course of IV drip, caution should be taken to avoid leakage of the drug from vein, which cause irritating pain. In case of low temperature in winter, it is advisable to place the bottle in the 30 water bath before use so as to get rid of physical irritation.
4. A disposable infusion system (including the end-filter) should be adopted.
5. If a de-lamination phenomenon of the lipid-emulsion occurs, the injection must be prohibited strictly from the intravenous use.
6. In case of slight phlebitis, a suitable amount (50-100 ml) of 0.9% sodium chloride or 5% glucose could be used before and after the IV instillation of Coix Injection.

SPESIFICATION:
100 ml: 10g

STORAGE:
To be stored in an airtight container and preserved at a cool place, protected from light, heat and being frozen.

VALIDITY:
18 months

PACKING:
In 100 ml glass infusion bottles, 1bottle/box.

APPROVAL CERTIFICATE NO.