Xcyte Therapies Discusses Plans for Phase II/III Trials Using Campath

[Guest guest]

[based on the following and on other material, it appears that Xcyte

believes their product will dovetail nicely with Campath. Since

Campath is very effective in clearing the blood of lymphocytes, but

much less effective on bulky nodes, and the Xcellerated T-cells work

pretty well reducing the size of nodes (in most cases by 50%), but

don't lower lymphocyte counts in the blood, there hopefully will be

some synergy.

Treatment protocol will have to be worked out through trials, meaning

what order the products will be used in, and in what dosages, etc.

Let's keep our fingers crossed on this. It might be very promising.

It's also interesting to remember that the HDMP+rituximab trials

operate on the theory that the methylprednisolone (Solu-Medrol) helps

drive the CLL cells out of the nodes. As noted here and elsewhere,

there are some side effects to high doses of Solu-Medrol (though not

major enough to preclude its use in therapy, obviously).]

Xcyte Therapies, Inc. Presents Results of Phase I/II Clinical Trial

of Xcellerated T Cells in Chronic Lymphocytic Leukemia at American

Society of Hematology Meeting

BIOWIRE2K

SEATTLE--(BUSINESS WIRE)--Dec. 6, 2004--

Discusses Plans for Phase II/III Trial

Xcyte Therapies, Inc. ( " Xcyte " ) (Nasdaq:XCYT) announced today that

results from a Phase I/II clinical trial of Xcellerated T Cells in

patients with chronic lymphocytic leukemia (CLL) were presented at

the American Society of Hematology meeting in San Diego yesterday.

Xcyte also discussed its plans for a Phase II/III clinical trial of

Xcellerated T Cells in patients who have received Campath

(alemtuzumab), which will be named the X-CLL Trial.

In the Phase I/II clinical trial, 17 patients received a single

infusion of Xcellerated T Cells without other treatment for their

leukemia. In CLL, leukemic cells infiltrate the lymph nodes, spleen

and blood, leading to enlargement of the lymph nodes and spleen and

increased numbers of leukemic cells in the blood. Following the

infusion of Xcellerated T Cells, 12 (71%) of 17 patients demonstrated

a 50% or greater decrease in the size of their enlarged lymph nodes.

Eleven (85%) of the 13 patients with an enlarged spleen demonstrated

a 50% or greater reduction in spleen size as determined by physical

examination. Decreases in leukemic cell counts in the blood were not

observed. Sustained increases in T lymphocytes as well as in

neutrophil and platelet counts were seen, suggesting that Xcellerated

T Cells may also have positive effects on many kinds of blood cells.

Observed side effects thought to be related to the therapy were low-

grade, and included fever, chills and headache associated with the

infusion.

Six patients received a second infusion of Xcellerated T Cells from 6

to 11 (median 10) months after the first infusion. Five of the 6

patients had measurable disease in their lymph nodes and spleen at

the time of the second infusion. In four of these patients, there was

a decrease in the size of the involved organs. Decreases in leukemic

cell counts were not observed.

" Based on the reduction in the size of lymph nodes and spleen

infiltrated with leukemic cells, we are encouraged to move forward

with the clinical development of Xcellerated T Cells in patients with

CLL, " said Mark Frohlich, M.D., Medical Director and Vice President

of Xcyte Therapies. " We are planning to initiate a Phase II/III trial

in patients with CLL who have received Campath (alemtuzumab), which

we have named the X-CLL Trial. Currently, patients with CLL who fail

treatment with Campath have no approved therapeutic options, and

these patients have a significant unmet medical need. "

" Campath is a standard treatment for advanced CLL, but it increases

the risk of infection because it eradicates nearly all T cells for

several months after treatment, " continued Dr. Frohlich. " In

addition, although Campath can decrease leukemic cell counts in the

blood, it has less therapeutic activity in the lymph nodes and

spleens of CLL patients. Accordingly, we believe there is a strong

clinical rationale for using Xcellerated T Cells after Campath

therapy. "

In the planned X-CLL Trial, patients who are refractory to

fludarabine or have received at least two prior chemotherapy

regimens, including at least one nucleoside analog-containing

regimen, will be eligible for the trial. Following leukapheresis, a

procedure to collect white blood cells to initiate the Xcellerate

Process, patients will be treated with Campath. Those patients who

fail to respond will enter one component of the X-CLL Trial and

receive Xcellerated T Cells. The primary endpoint of the X-CLL Trial

will be the response rate in these patients. Those patients who

respond to Campath will be eligible to enter a second component of

the X-CLL trial.

" We discussed our plans for this Phase II/III trial with the Food and

Drug Administration (FDA) at an End of Phase II meeting in

September, " said Ron Berenson, M.D., President and Chief Executive

Officer of Xcyte Therapies. " We are currently working with the FDA to

finalize the X-CLL Trial protocol and to review our manufacturing

plans for this trial. We intend to manufacture Xcellerated T Cells

for this trial in our newly completed manufacturing facility in

Bothell, Washington. If the FDA accepts our protocol and

manufacturing plans, we expect to enroll our first patient in the X-

CLL trial by the end of the second quarter of 2005. "