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Biotech / Medical : Biotech Valuation
CRSP 56.68-2.4%Dec 12 9:30 AM EST

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To: Biomaven who started this subject2/4/2003 12:11:38 AM
From: John McCarthy  Read Replies (1) of 52153
 
Is this as good as it sounds ..........

>>>>>>>>>>>>>>>
Induction of T cells by OvaRex(R), which occurred in 61% of the patients, was associated with a significant survival advantage, with median survival for T cell responders not reached (64% still alive at 140 weeks)
versus 51.9 weeks for T cell non-responders (p=0.002; hazard ratio 0.157 [0.009-0.347]).
>>>>>>>>>>>>>>>

In context -

WALTHAM, Mass., Feb. 3 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSE: AXO, OTC: ALXFF.PK) announced today that Dr. Alan Gordon of U.S. Oncology and Texas Oncology PA of Dallas, Texas presented updated survival data from a 20 patient OvaRex(R) (oregovamab) phase II trial
conducted by AltaRex yesterday at the opening oral plenary session of the Society for Gynecological Oncology (SGO). The results demonstrated that in this study there was a correlation between OvaRex(R)-induced T cell responses
and prolonged survival in platinum-sensitive patients with recurrent epithelial ovarian cancer.

The objectives of the study were to evaluate immune responses and clinical outcomes from concurrent OvaRex(R) and chemotherapy treatment. The conclusions were that OvaRex(R) MAb induced multifaceted antigen-specific
immune responses even when combined with chemotherapy and that patients with a T cell response survived significantly longer than those without a T cell
response.


Induction of T cells by OvaRex(R), which occurred in 61% of the patients, was associated with a significant survival advantage, with median survival for T cell responders not reached (64% still alive at 140 weeks)
versus 51.9 weeks for T cell non-responders (p=0.002; hazard ratio 0.157 [0.009-0.347]).


The Company believes that the high frequency of beneficial OvaRex(R)- induced immune responses seen in the study in conjunction with chemotherapy strongly supports additional evaluation and has initiated discussions with the European Organization for the Research and Treatment of Cancer (EORTC) in that regard. Further, in a recent publication in the New England Journal of Medicine by Zhang et al., the authors report on their munohistochemical
analysis of tumor infiltrating lymphocytes in 186 frozen tumor specimens obtained from primary debulking surgery of FIGO III and IV ovarian cancer patients. The paper, entitled "Intratumoral T cells, Recurrence and Survival
in Epithelial Ovarian Cancer", makes several observations relevant to OvaRex(R) immune induction and the survival benefit reported at SGO:

-- Patients with advanced ovarian cancer have significantly longer overall and progression-free survival if there are tumor-infiltrating lymphocytes present (p<0.001).


-- Significantly longer survival was also observed among the patients in which a complete response to primary therapy (optimal debulking and adjuvant chemotherapy) occurred and the tumor was infiltrated by lymphocytes (p<0.001); the five-year overall survival rate was 74% among these patients whose tumors contained T-cells and 12% among those with no T cells.


-- Among patients with a complete response to primary therapy, the presence or absence of T cells (p<0.001) and the extent of residual tumor (p<0.001) correlated with overall survival but tumor grade, histologic type, inclusion or non-inclusion of paclitaxel in the chemotherapeutic regimen, and age did not.

The finding from the Zhang paper regarding optimal debulking is addressed by Unither Pharmaceuticals, the Company's licensee for North America, Japan and other territories, in their pivotal double-blind placebo-controlled U.S. phase III trials where the target population is advanced ovarian cancer patients whose primary therapy resulted in optimal debulking, chemo-responsive disease, and CA125 in the normal range. This population was identified from the previously reported AltaRex phase IIb trial in 345 patients.

With regard to Europe, AltaRex continues a dialogue with the EORTC regarding the conduct of a phase II trial in patients with recurrent disease who were previously optimally debulked and had chemo-sensitive disease (>6
month progression free survival). This study is intended to further elucidate Dr. Gordon's observations regarding the synergistic effect of immunotherapy and chemotherapy on T cell induction and resulting survival benefit.

AltaRex Corp. is focused on the research, development and commercialization of foreign antibodies that modulate the immune system for the treatment of certain cancers and other diseases where there exists an unmet medical need. Additional information about AltaRex Corp. can be found on
the Company website at altarex.com.

prnewswire.com

Additionally - on the same topic
OVARIAN CANCER
A possible different and better treatment ....

1: Gan To Kagaku Ryoho 2003 Jan;30(1):141-4 Related Articles, Links

[Two cases of complete response to combination chemotherapy of gemcitabine and docetaxel for recurrent ovarian cancer]

[Article in Japanese]

Ito K, Adachi S, Iijima T, Nakatsuji Y, Kimura T, Nobunaga T.
Dept. of Obstetrics and Gynecology, Kansai Rosai Hospital.

The established standard treatment for advanced ovarian cancer is carboplatin and paclitaxel. However, more than 70% of patients have recurrent disease. The standard therapy for recurrent ovarian cancer has not been confirmed. It was reported that docetaxel had a 30-40% of response rate in patients with recurrent ovarian cancer, and that gemcitabine had a 13-22% response rate. The combination chemotherapy of gemcitabine and docetaxel is also applied to non-small cell lung cancer. We use a regimen of 800 mg/m2 of gemcitabine on day 1 and day 8 in combination with 70 mg/m2 of docetaxel on day 8 with a 3-week interval. We treated 2 patients with recurrent ovarian cancer who responded completely to combination chemotherapy with gemcitabine and docetaxel.

PMID: 12557720 [PubMed - in process]

ncbi.nlm.nih.gov

John McCarthy
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