Virulizin

[Lillie]

I haven't posted much I mostly just read. My mama has SCLC with mets to the liver. She was diagnoised May of 2002, and she is still doing ok considering. I have a question to ask you all. Has anybody done any research on Virulizin or has anybody did it in a trial? Mama had breast cancer 4 years before her diagnosis with lung cancer and she can't do a lot of the trials. I've learned that the Virulizin can be purchased and given to the patient but I'd have to go out of the country to get the virulizin. I'm going to speak with mama's oncologist tomorrow and I will ask him about it as well but I mostly wanted any input that any of you may have. Thank you now for any replys. Hugs Lillie

[john]

It seems as Virulizin is a real drug with some potential. Though it is currently being used for pancreatic and melanomas.

I definitely would not treat myself with this. If you can get into a clinical trial somehow in outside the country it might be worth it though I imagine probably very expensive.

God bless

Antitumor activity of Virulizin, a novel biological response modifier (BRM) in a panel of human pancreatic cancer and melanoma xenografts.

Feng N, Jin H, Wang M, Du C, Wright JA, Young AH.

Lorus Therapeutics Inc, 2 Meridian Road, ON M9W 4Z7, Toronto, Canada.

PURPOSE: To define the anticancer efficacy of Virulizin in vivo as a single agent or in combination with conventional drugs in human pancreatic tumor and melanoma xenografts. METHODS: The therapeutic effect of Virulizin was evaluated in a series of human tumor xenografts in athymic nude mice. RESULTS: Virulizin had a high level of antitumor activity against all the pancreatic tumors (BxPC-3, SU 86.86. and Mia-PaCa-2) and melanomas (C8161 and A2058), as indicated by suppression of tumor growth with an optimal T/C value of

[Lillie]

Yes, you are right it is used right now in a trial for PC that is how I found out about the virulizin. I spoke with mama's oncologist this afternoon, he is not against me getting it for her or administering it to her, actually what he said is that it may be more promising than anything he can offer her presently. The bad part of it all is I'd have to go to Mexico to get the virulizin and I don't like that at all. Below is another site for you to read that shows other "POSSIBLE" cancers it may help. I'm going to find out exactly what all I must do to to get the virulizin a lady I know on the pancreatic chat board is leaving Fri. for Mexico to get the virulizin and I hope to speak with her to see what all is involved. I will keep you informed of what I learn. Hugs Lillie

Virulizin®, based on a relatively new approach to the treatment of cancer termed immunotherapy, relies on the drugs ability to activate the body’s own immune system to recognize and eliminate cancer cells. Virulizin®‘s product position is good with a strong safety profile, equal or superior efficacy than existing treatments and the potential for use in both single and combination therapy for treatment of a broad range of diseases.

Lead cancer indications for Virulizin® include Pancreatic Cancer, Malignant Melanoma, and Kaposi’s Sarcoma (KS). Other possible cancer indications include Lung Cancer, Breast Cancer, Uterine, Ovarian and Cervical Cancer. Additional possible non-cancer indications include immune system disorders such as Endometriosis, as well as viral diseases, such as HIV, Hepatitis B and C, Herpes Simplex Virus, Cytomagalovirus and HPV. Virulizin® may also prove to be an appropriate adjuvant to therapeutic vaccines.

The mechanism of action of Virulizin® remains the subject of ongoing research. Results to date have shown that (1) Virulizin® stimulates the release of tumour necrosis factor, TNF-alpha, by tumour cells in vitro. (2) Virulizin® is a powerful stimulating agent of macrophage, the “big eater” cells of the immune system. Consequently, Virulizin® enhanced the ability of macrophage to kill tumour cells in our experimental system. (3) Virulizin® appears to induce apoptosis, or programmed cell death, of tumour cells.

Virulizin® has several competitive advantages over existing cancer treatments. Clinical trial results have indicated that Virulizin® performs equally or better than currently available products like Gemzar® or conventional treatments. Furthermore, in clinical studies, the maximum tolerated dose has never been reached. This profile for Virulizin® will compare favourably with chemotherapeutic agents and other Biological Response Modifiers. The low toxicity of Virulizin® may provide patients with a better quality of life. A favourable clinical response has been noted with immunosuppressed patients, such as those with AIDS/KS, versus some other Biological Response Modifiers. A favourable clinical response has also been noted with patients receiving other cytotoxic therapy. This coupled with the low toxicity of the product make it a good choice for combination therapy with existing treatments. The fact that Virulizin® is currently administered as an intramuscular injection will allow for treatment on an outpatient basis.

A Phase III clinical trial to evaluate Virulizin for the treatment of advanced pancreatic cancer was initiated in November, 2001. The double-blind, randomized clinical trial will be conducted at approximately 40 North American medical centers with the goal of enrolling 350 patients with advanced (unresectable, recurrent or metastatic) pancreatic cancer. Patients will be randomized to receive either treatment with gemcitabine or treatment with gemcitabine in combination with Virulizin. Those patients who fail or become refractory to gemcitabine will then be treated with 5-Fluorouracil (5-FU) or with 5-FU in combination with Virulizin.

Immunotherapy, Macrophages and Virulizin®

Immunotherapy

Major advances in cancer therapy have been made in the past two decades. One of the most significant advances has been the emergence of immunotherapy, or biological therapy, a clinical approach that stimulates the body's natural defenses against cancer using Biological Response Modifiers (BRM).

Clinical data have indicated that solid tumors have antigens that are recognized by cells of the immune system, including a certain type of white blood cell called a macrophage. When macrophages are activated, they are believed to enhance the immune system's rejection of tumors by producing cytokines, or proteins. These cytokines can either kill tumor cells directly or stimulate the anti-tumor activity of other cell types.

Activation of macrophages by the drug at the site of the tumor

Macrophages

Macrophages are located throughout the body and serve as an important line of defense in several ways. One of their most crucial roles is to protect the body against the development of cancer. Scientists still do not fully understand the control of this macrophage-mediated tumor cell destruction, a fact that has slowed the development of successful immunotherapy for many types of cancer.

Virulizin®

Virulizin® is a potent and unique activator of human macrophages and may have significant potential in the immunotherapy of cancer patients. The drug is purified from bovine bile through a proprietary production process at Lorus's manufacturing facility.

Virulizin® has been shown in vitro to directly stimulate certain macrophages to express a tumor-killing function. Virulizin's® function, or cytocidal capacity, has been shown to be as potent as other, more conventional macrophage activators. Additional evidence suggests that Virulizin® has potential as an immunotherapeutic drug in the treatment of many forms of cancer.

Even more important is the finding that macrophages taken from cancer patients can be activated by Virulizin® despite the inability of these same macrophages to respond to other conventional activators. In other in vitro studies, Virulizin® has been shown to stimulate the macrophage-mediated destruction of tumors obtained from patients undergoing chemotherapy.

In the last eight years, Virulizin® has been evaluated in over 450 patients who received more than 16,000 injections of the drug Virulizin® and has demonstrated an excellent safety profile. Preliminary results suggest that Virulizin® immunotherapy may be associated with prolonged patient survival and an improved quality of life. Moreover, patients with pancreatic cancer and malignant melanoma have survived longer,compared to historical controls, when they have been administered Virulizin®.