News and Comments


Prohost Biotech - Saturday, January 02, 2010
At the 51st American Society Hematology (ASH) Annual Meeting in New Orleans, LA. Sunesis presented data from two Phase 2 clinical trials of its drug Voreloxin on patients suffering from difficult to treat acute myeloid leukemia (AML). The results, as announced, were positive and demonstrated voreloxin's efficacy and safety when used as a single agent or in combination with chemotherapy.

The lecturer and the firm’s representatives were extremely optimistic during the presentation. The demonstrated safety and efficacy were sufficient to move Voreloxin forward in clinical trials. The high rates of remission demonstrated durable effects and meaningful preliminary overall survival. As a result, Sunesis said it is looking forward to discussing the clinical trial data with the FDA in its End-of-Phase 2 meeting scheduled for the first quarter of 2010.

Could Voreloxin be the drug that offers AML patients what they desperately hope for? All we can say at this point is that in combination regimens of Voreloxin with Cytarabine in phase 1b/2 clinical trial on primary refractory and first relapse AML patients, the drug realized preliminary median overall survival of 7.8 months compared to historical median overall survival of 3.4 to 5.9 months in same category of patients taking currently available chemotherapies. The combination demonstrated meaningful anti-leukemic activity with an acceptable tolerability profile in difficult-to-treat patients. Such results cannot be overlooked.

Good news is that a recommended pivotal dose-regimen of Voreloxin used in combination with cytarabine has been identified.

Phase 2 dose optimization trial (REVEAL-1 Trial) in 113 elderly AML previously untreated patients who are unlikely to benefit from standard induction chemotherapy have demonstrated positive results. In these trials, patients followed three schedules:

Schedule A: Once weekly for three weeks.
Schedule B: Once weekly for two weeks.
Schedule C: On days one and four at either 72 mg/m2 or 90 mg/m2.

Schedule C was the winner and the one to be adopted.

Based on trial results, Schedule C is chosen to be the recommended pivotal dose regimen. In schedule C, response rates (CR and CRp) are 38%; 30- and 60-day. All-cause mortality are 7% and 17% with improved tolerability over Schedule A.

Do we have any reasons for Skepticism? Skepticism in this case has no place, as it can only mean that the data are fabricated, which is irrational.


Do we believe that the drug is, indeed, the miracle that desperate patients are waiting for?

We have many reasons to believe that the results are, indeed, positive and represent genuine clinical evidence. On the other hand, these results are not definitive and still need to be confirmed. The drug has to pass the final phase studies. Nevertheless, the results came from real trials conducted on real desperate patients; some would have been dead if they were treated with the conventional regimens. The mid-phase trial results are in favor of the drug, but no one can really swear that the same results will be duplicated in phase 3 trials.

We are optimistic. We have more confidence than ever in the capability of Sunesis in planning and conducting successful clinical trials. But we cannot speculate over the outcome because in this particular case, although we have incomplete clinical evidence we lack scientific evidence. Voreloxin is not a cancer drug and there is no scientific explanation as of how it does its job on leukemic cells. This is not a hurdle, but something to consider, especially that Voreloxin has never before been considered for cancer treatment and its structure, under various known and unknown circumstances could end up becoming therapeutically futile.

With regard to the stock, we believe what could boost the stock price and double our enthusiasm in the same time is that a deep-pocketed pharmaceutical company comes forwards and hands Sunesis a lucrative contract with a substantial amount of upfront payment to get involved in the drug. As a matter of fact, some analysts and investors expect this scenario to happen anytime soon, which might have added to fuel to the stock’s recent rally.

Do we buy the stock?

We take advantage of the profit-taking to buy a small amount and then wait for the news about the drug and the possible collaborative agreement and then we cross the bridge when we reach it.

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may”, “expects”, “anticipates”, “believes”, and “intends”, and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are identified and more fully explained under the heading "Risk Factors" in Compugen's annual reports filed with the Securities and Exchange Commission.
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