MBVax Results

The patients who have used MBVax Coley Fluid are almost exclusively end-stage, suffering from the many effects of previous treatments and with few remaining treatment options. The table is a preliminary summary of physicians’ reports on patients treated for four or more weeks under the MBVax compassionate use program. The table may not include all patients treated due to lack of or inadequate reporting from the administering clinics. MBVax believes these results are indicative of the results of the entire program.

 

Number of Patients

Type of Cancer

Complete response no detectable cancer

Partial response confirmed regression

Improvement in pain, appetite, depression and/or mobility

No improvement

19

Breast

8

10

1

25

Breast

8

14

2

1

9

Lymphoma

4

4

1

7

Prostate

4

2

1

6

Ovarian

4

2

6

Melanoma

2

2

1

1

4

Liver

1

3

4

Lung

1

2

1

4

Sarcoma

2

2

3

Colon

2

1

3

Pancreas

1

2

2

Esophagus

1

1

2

Brain

1

1

2

Stomach

2

1

Anal

1

1

Cervical

1

1

Gall Bladder

1

1

Larynx

1

1

Multiple Myeloma

1

1

Rectal

1

1

Mesothelioma

1

1

Squamous

1

1

Tongue

1

86

18

43

18

7

Following are case summaries of 22 patients.

Case 1 – breast cancer

On diagnosis in 1993, a 6 cm mass was detected in the left breast. First line therapy was a modified radical mastectomy with lymph-node dissection; six of 21 lymph nodes were invaded by malignant cells; patient was staged as IIIA (T3 N1 M0). Chemotherapy with Cytoxan, methotrexate, and 5FU was given per standard protocol. Patient was started on tamoxifen, which was discontinued immediately when she developed endometrial cancer for which she had a total abdominal hysterectomy. In January 2001, she underwent two additional cycles of chemotherapy. In September 2003, a PET scan demonstrated multiple lymph nodes and skeletal lesions, and a chest x-ray revealed a 1.5-cm left mid-lung mass. In January 2004, CT revealed multiple lung tumors and a bone scan demonstrated progression with new extensive metastatic disease involving the anterior calvarium, the left sternoclavicular region, several bilateral ribs, the sternum, the spine throughout its cervical, thoracic, and lumbar vertebrae, as well as multiple lesions in the pelvis, and at least two lesions in the right proximal femur. Patient tried various alternative treatments before starting Coley Fluid in October 2006. A PET/CT of May 2007 demonstrated “Stable uptake in the left clavicle; stable right hilar uptake, probably benign; widespread mottled appearance of the bones, but no sugar uptake, suggesting healed metastatic bone disease.” Patient achieved complete remission.

Case 2 – breast cancer

An 18-year history of breast cancer (invasive ductal carcinoma) initially treated with radiation and lumpectomy. Two years later, cancer recurred in the opposite breast and was again operated and radiated, and subsequent recurrences required a total of 15 lumpectomies. Upon starting Coley Fluid in December 2006, the patient had an open ulcer on a very enlarged left breast and half a dozen satellite tumors under the breast, and ultrasound demonstrated one right-sided nodule and six left-sided nodules with a non-healing ulcer. Her oncologist advised mastectomy, but she declined. She had many sub range fevers in the beginning months, and quite a few gaps of weeks between injections, but graduated to higher fevers as she became more aggressive in the summer of 2007. Once leukocytosis began, the breast shrank rapidly over the course of about six weeks. Her breast is entirely normal now, and there are no residual signs or scars. She was treated with intratumoral injections only (no intravenous or intramuscular injections). Patient achieved complete remission.

Case 3 – breast cancer

Patient with metastatic breast cancer received less than one week Coley Fluid therapy at a foreign clinic. She was very sensitive to the vaccine and produced fevers above 40C. On return to her home country, she continued treatment with Coley Fluid. In September 2007, her chest X-ray was clear and blood work including all tumor markers normal. A bone scan came back normal. Whole-body PET/CT scan found no metastases. Patient achieved complete remission.

Case 4 – cervical cancer

Massive, rapidly growing cervical cancer with bone metastases and large ulcerating tumor on the left leg, patient was not able to walk. The attending physician stated, “Her cancer was one of the worst I have ever seen”. Following initiation of intravenous Coley Fluid, edema and cancer pain were reduced and there was a prominent reduction in primary tumor and bone metastases. After 3 weeks, patient improved to the extent that she was up and walking, and was sent home from the hospital. On returning home, treatment was not continued and disease began to progress. Patient subsequently lost to follow-up.

Case 5 – colon cancer

Large metastatic colorectal cancer with metastases to pelvic cavity and vagina. After 3 weeks of intravenous Coley Fluid treatment, there was a dramatic reduction in the tumor (over 70% of volume).

Case 6 – colon cancer

Colon cancer with metastases to bone. Patient had two previous intra-abdominal surgeries. Approximately 50% reduction of tumor since starting Coley Fluid intramuscularly.

Case 7 – esophageal cancer

Stage 4 esophageal cancer recurrence after previous esophagectomy in 2000. In March 2007, patient presented with weight loss, cough, shortness of breath, difficulty swallowing and weakness. A large fast-growing pancreatic tumor and smaller lung tumor were diagnosed tumor with marker CEA measured at 223.8. After intramuscular Coley Fluid, cough was alleviated, lung function improved and there were no difficulties in swallowing. In September 2007 patient developed bleeding from the pancreatic tumor. A PET/CT scan showed partial necrosis of the lung and pancreatic tumors that may have precipitated the bleeding. Decreased SUV values were seen for both tumors compared to Mar 07 scan. Bleeding was halted with 15 treatments of local radiation (not to lung). During period to correct bleeding patient discontinued vaccine and lung tumor increased in size. Patient reinitiated Coley Fluid treatment and by March 2008 PET/CT scan showed pancreatic tumor was dead. The CEA reduced to 2.1 (normal <3) and the patient regained lost weight and strength. In April, the patient took a 10-day motorcycle trip.

Case 8 – liver cancer

Locally advanced liver cancer. Patient taking chemotherapy and Coley Fluid intramuscularly. Approximately 70% reduction in tumor since starting therapy.

Case 9 – lung cancer

Upper left lung carcinoma with metastases kidneys, liver and bones (female, H 153cm; W 64.3kg [27.5 kg/m2]). After six weeks intensive (five days weekly) intravenous Coley Fluid therapy, patient had improved appetite, mood, disappearance of chest pain, and X-ray and CT scans showed no remaining evidence of cancer. Patient achieved complete remission.

Case 10 – lung cancer

Lung cancer with kidney metastases (H 167cm; W 85kg [30.5 kg/m2]) and a long history arthritis/arthrosis. Tried two courses of chemotherapy, but felt worse and discontinued. After starting Coley Fluid patient was able to go up and down stairs more easily, improved sleep. Patient said, “I can’t explain but I feel better, I breathe better, I eat better, I am better.” Chest mass diminished in size. Patient was able to go back to work as salesman

Case 11 – lymphoma

Patient with metastatic mediastinal lymphoma diagnosed in 2003 and previously treated with chemotherapy, but due to lack of efficacy and poor quality of life patient declined further treatment. Began Coley Fluid in May 2009 with steady improvement in health. Returned to work in November 09. Patient achieved complete remission.

Case 12 – lymphoma

Patient with Hodgkin lymphoma with enlargement of nodes in the neck. No previous treatments. The patient had one 3 cm node and a cluster of small lymph nodes that could be felt by palpation. The largest node was reduced to 1.5 cm and was more mobile and the small cluster of nodes was less palpable. There have been no intratumoral or peritumoral injections. Patient discontinued vaccine in Nov 07 and by Mar 08 tumors had grown back to their original size. Patient then resumed intravenous Coley Fluid and tumors again started to decrease. Patient then discontinued treatment and tumors regrew. In the summer of 2009, the patient began intravenous Coley Fluid treatment again achieving a 50% reduction in his tumors with moderate fevers.

Case 13 – lymphoma

Patient with mantle cell lymphoma. Tumors on the neck were reduced to one-quarter original size after three weeks of intramuscular Coley Fluid treatment. Patient subsequently received a stem cell transplant with chemotherapy and is presently in remission.

Case 14 – lymphoma

Patient with follicular lymphoma originally diagnosed in 1995 as stage 4 due to bone marrow involvement. Many previous chemotherapy treatments. In 2007 prior to Coley Fluid therapy there were several large nodes in groin, a small node on clavicle, and many enlarged nodes in abdomen causing swelling and itchiness, also pain below liver, and hand and foot cramps. Due to hydronephrosis in left kidney, a stent was inserted into the left ureter. Coley Fluid therapy was injected intratumorally into groin. Improved kidney function led to permanent removal of ureter stent in Dec 08. External nodes in groin regressed, liver pain disappeared, swelling of abdomen reduced, platelets and liver function tests improved, itching and cramps have disappeared. CT scans up to Nov 09 show continuing shrinkage of tumors with the disappearance of many lesions, including nodes in groin. Now active, hiking and continuing Coley Fluid.

Case 15 – lymphoma

Patient with B cell lymphoma with one mediastinal tumor (3.6 cm) and one neck tumor measuring 5.9 cm. The latter tumor was compressing his trachea and his carotid artery by 75%. Following alternating intramuscular and intravenous Coley Fluid, a CT scan showed a 51% reduction in the neck tumor and a stable mediastinal mass. Following a second course of Coley Fluid, the patient’s bloodworm normalized and a subsequent PET/CT scan showed only a ring of hypermetabolic activity with a necrotic core in both tumors. All previous tissue injection sites were hypermetabolic on the PET/CT as were draining lymph nodes (this would represent non-malignant inflammation). The carotid artery now shows normalized blood flow and the cough has disappeared.

Case 16 – lymphoma

Patient with large inoperable left sided mantle cell lymphoma. The tumor under his left arm extended to the sternum with associated enlarged nodes. Patient could not lower his arm due to the extensive size of the tumor. The patient was treated with Coley Fluid intratumorally only, beginning in April 2009. After 5 months of treatment, the tumor regressed to size of a lemon and patient could lower his arm with greater mobility. Malignant nodes opened up twice during treatment with drainage of necrotic tumor tissue. The Coley Fluid caused prolonged fevers lasting up to 2 days, which were often associated with nausea and vomiting. Despite regression of the primary tumor, the inguinal nodes in the groin began to enlarge. Due to side effects, patient decided to discontinue treatment in October 2009 and appeared in poor health. In April 2010, the patient returned to his physician who observed that the tumor under his arm had disappeared and the nodes in the groin regressed. The patient has now gone back to his favorite pastime, golfing.

Case 17 – multiple myeloma

Patient had two previous bone marrow transplants with chemotherapy. She had a history of increasing tumor markers (M protein) before starting the therapy. Patient began Coley Fluid in October 2006. In January 2007, a skeletal survey, bone marrow biopsy, and 24 hour urine test were negative for myeloma. Subsequently discontinued vaccine in Nov 07. Follow-up MRI in Apr 09 was negative. Tumor markers stable showing a low residual M protein level up to last follow-up in Feb 2010. Patient is physically well.

Case 18 – ovarian cancer

Patient had multiple cancerous lesions in her abdomen before treatment. A CT scan in Dec 2006 showed disappearance of all lesions, except one. Her hemoglobin improved, as did her strength and energy. Adverse effects included an increase in bone pain following the vaccination. This is believed to be due to stimulation of the bone marrow to produce more immune cells as the patient did not have evidence of cancer in the bone. This patient also developed a superficial staphylococcal infection near points of injection. This was successfully treated with antibiotics.  Finally, this patient was overweight and lost about 15 pounds since the start of the therapy.

Case 19 – ovarian cancer

Ovarian cancer in abdominal region. Intramuscular Coley Fluid treatment led to reduced ascites, tumor shrinkage by approximately 50%, improved appetite and decreased tumor pain.

Case 20 – ovarian cancer

Patient with metastatic ovarian cancer received two weeks intravenous Coley Fluid therapy at an international clinic. CA 125 marker in the thousands declined to 36 following two weeks of intravenous Coley Fluid therapy. Patient was unable to continue therapy on return home.

Case 21 – pancreatic cancer

Patient was rapidly losing weight (2 pounds per day) when diagnosed in December 2007 with stage 4 pancreatic cancer. Pre-treatment, a CT scan showed the largest tumor, surrounding the mesenteric vein and artery, to be 15.5 cm. There were metastases in the liver and possibly bone. Patient received three weeks Coley Fluid therapy at an international clinic. After three weeks therapy, ultrasound examination showed the large pancreatic tumor had reduced to 9.4 cm and four liver metastases previously seen on CT were no longer visible. The patient regained some weight, and digestion and liver function tests improved. Patient returned to home country where therapy could not be continued. Disease progressed.

Case 22 – stomach cancer
Male, 60 years, with locally advanced ulcerated stage IV stomach cancer. Tumor was greater than 5 cm with metastases to surrounding lymph nodes. Patient received 55 intramuscular Coley Fluid treatments. Patient achieved complete remission.