Interpreting The New        May 13, 2005

 ASCO   

THE GIANTS AND THE DWARFS

 Dwarfs by far outsmart the giants in the art of propaganda, which realizes their caprice at the expense of anything, including reality. Their persistence blinds all kind of reason and, sometimes, creates pattern accepted even by the most intelligent. That’s what the capricious have consistently done in the last ASCO and three out of four before it. They created the notion that no matter how breakthroughs and effective the cancer products presented in the conference were, we should sell the stocks of their developers. The reasons? They used hundreds of them, which, although irrational, many rational investors usually sell their cancer stocks because they are made to believe that computers are programmed to interpret the word ASCO as a sell signal for the cancer companies no matter how good their product might be. 

Will this happen too this year?

Irrationality, like anything else in this world, has limits. The advancement in cancer treatments at the hands of drugs that had not satisfied the capricious is much much bigger than to be ignored or demeaned. AVASTIN, RITUXAN, HERCEPTIN, TARCEVA, ERBITUX are all in the market and are making what can amount to miracles.

How many times we tried to tell our subscribers that experimental treatments are called experimental because they are subject to trial and error. The developing biotech firms or pharmaceutical companies are not playing. They are serious and are bringing molecules that are validated, but need to be used as best as researchers can. Having bad results, one, or two times, does not really mean that the products should be condemned as the capricious jump to claim at each and every moment a setback occurs. 

IN THE NEWS

GENTA (GNTA)

In the news, we see Genta's cancer drug, Genasense, which had been  prematurely condemned, make a good comeback. A Phase 3 trial for relapsed or refractory chronic lymphocytic leukemia (CLL) has achieved its primary end-point, with a statistically significant increase in the proportion of patients who achieved either a complete response (CR) or a nodular partial response (nPR). This was last December. With an additional 6 months of follow-up, one additional patient in the Genasense treatment group has achieved a nPR. Overall, 20 patients (17%) in the Genasense plus chemotherapy group achieved a CR or nPR compared with 8 patients (7%) in the chemotherapy only group (P=0.025). Extended follow-up has now shown that the duration of CR/nPR is significantly superior for patients in the Genasense treatment group (P=0.035).

Five of 8 patients (63%) have relapsed on the chemotherapy only arm compared with 4 of 20 patients (20%) on the Genasense treatment arm.

Study Design, Patient Enrollment and Adverse Experience: Patients were eligible for this trial if they had failed standard treatment for CLL that had included fludarabine. Two hundred forty one patients were randomized to receive standard chemotherapy with fludarabine and cyclophosphamide with or without Genasense. In the trial, 120 patients were randomized to receive Genasense plus chemotherapy, and 121 patients were randomized to receive chemotherapy alone. During the study, the incidence of any Grade 3 or Grade 4 serious adverse event was higher in the Genasense group. Specific events that were significantly higher in the Genasense group included (but were not limited to) thrombocytopenia, nausea, fever, fatigue, back pain, weight loss, dehydration, and intravenous catheter complications. However, serious adverse events that resulted in discontinuation of therapy were equal between the treatment arms. Treatment-emergent adverse events that led to deaths on study or within 30 days from last treatment occurred in 9 patients in the Genasense group and 5 patients in the chemotherapy alone group. Other efficacy and safety information from the trial can be accessed at: http://www.genta.com/Genta/InvestorRelation/2004/press_20041206.html .

  Genasense inhibits production of Bcl-2, a protein made by cancer cells. Why important? Because  Bcl-2 seems to block chemotherapy-induced cell-killing (apoptosis). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current treatments for CLL.

As we mentioned in Prohost Newsletter, some products are developed to increase the efficacy of other existing products. These products can show their strength in combination therapy of course, which is what many biotech firms are doing now. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

It is one out of the flood of good news that we will be witnessing from now on.

PROHOST RESEARCH

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