Telcyta, een immuuntherapeutisch middel zorgt voor goede resultaten in fase II trials bij patienten met niet-klein-cellige longkanker

15 juni 2012: voor laatste stand van zaken betreffende immuuntherapie bij longkanker zie deze twee studies: Immuuntherapie bij gevorderde niet-klein-cellige longkanker lijkt een goede aanpak te kunnen worden in de nabije toekomst en deze: Immuuntherapie bij longkanker: overzicht van stand van zaken aan de hand van studieresultaten van laatste 10 jaar

Er loopt op dit moment een fase III studie van Telcyta plus chemo bij niet-klein-cellige longkanker. Op de website van Telik kunt u wellicht nadere informatie daarover verkrijgen.

Dit zijn de lopende studies:

ASSIST-2 (Assessment of Survival In Solid Tumors-2): Phase 3 Randomized Study of TELCYTA (TLK286) Versus Gefitinib as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Phase 2 Study of TELCYTA (TLK286) in Combination with Carboplatin and Paclitaxel as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Phase 2 Study of TELCYTA (TLK286) in Combination with Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Phase 2 Study of TELCYTA (TLK286) in Combination with Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer.

juni 2003:

Een op molecuulbasis geënt middel - Telcyta (TELK) of TLK286, zorgt in een fase II studie bij patiënten met niet-klein-cellige-longkanker voor ongekende resultaten in levensduur en kwaliteit van leven. Alle 33 patiënten hadden al verschillende chemo's en andere behandelingen achter de rug zonder succes en hun levensverwachting lag bij aanvang van de studie met Telcyta op 2 1/2 tot 5 1/2 maand. Deze studie begon juli 2002 en nu d.d. 2 juni 2003 leven nog 27 van de 33 deelnemende patiënten. Waarbij bovendien wordt gezegd dat de kwaliteit van leven zienderogen is verbeterd en er nagenoeg geen bijwerkingen waren van dit middel Tercyta. Tercyta zou alleen de voedselinname van kankercellen blokkeren en de kankercellen aanzetten tot apoptosis (zelfmoord) en de gezonde cellen ongemoeid laten.

Hieronder het persbericht zoals dat vandaag 2 juni 2003 op de DOW werd gepresenteerd.

=DJ Telik Drug Extends Lung Cancer Patients' Survival Rates --

By Daniel Rosenberg
Of DOW JONES NEWSWIRES

CHICAGO (Dow Jones)--An in-progress follow-up trial on advanced lung cancer
patients treated with Telik Inc.'s (TELK) investigational drug Telcyta confirms
earlier data that the drug increases survival times, company executives said
Saturday. The Phase II trial, involving non-small cell lung cancer patients
who have failed two or more previous therapies and who have life expectancies of
four and a half to six and a half months, began last July. Enrollment continued
through the following months.
Of the 33 patients enrolled, 27, or 81%, are still alive, said Dr. Gail Brown,
senior vice president and chief medical officer at Telik, in an interview at the
American Society of Clinical Oncology annual meeting here. The trial continues.
"That's a very good survival rate," Brown said. "These are very advanced
patients who have failed all previous therapies."
She said this trial appears to validate the results of a Phase I trial with
the drug that showed a median survival of nine months for an even sicker group
of 53 lung cancer patients who had a life expectancy of four and a half months
or less. Thirty-eight percent of those patients lived a year or more. "The
second trial is confirmatory," Brown said. "This patient population is also
surviving longer than expected."
The goal of the trial is to determine median survival. When 50% of the
enrolled patients die, a median survival rate can be determined. Final results
could come as soon as this fall, or could come later if the trial hasn't reached
the 50% mark by that time.
"That would be a nice problem to have," Brown said.
Survival is the primary goal of the current study, Brown added. But the study
also seems to indicate that Telcyta is well tolerated by patients, even though
it's being given to them every week instead of every third week as in the prior
trial. There have been no grade-four adverse events in these patients, and only
a few grade-three events. The higher the grade, the worse the reaction to the
drug.
Many cancer drugs, Brown said, have 60% to 70% of patients experiencing
grade-three or grade-four adverse events.
"Patients have done extremely well on our drug," Brown said.
Telcyta, or TLK286, is a small molecule compound that has a novel "smart"
mechanism of activation within cancer cells. Upon activation, Telcyta initiates
an intracellular process known as apoptosis, or programmed cell death. This
process - which leaves non-cancer cells unaffected - may explain why the drug is
so well tolerated, Telik says on its Web site.
To date, more than 350 patients have been enrolled in trials with Telcyta, the
company said. Telik has received approval from the U.S. Food and Drug
Administration to go forward with Phase III trials of the drug for ovarian and
lung cancer. The ovarian trial was launched in March, and Telik expects to start
the Phase III lung cancer trial in the second half of the year. It has also has
done trials of the drug with breast and colon cancer.
"We hope to get this drug to market in the near future and commercialize it
ourselves," said Brown, whose company also has other drugs in development -
including one for cancer and another for diabetes.
Mark Monane, analyst with Needham & Co., said Telcyta probably won't be on the
market until 2006.
But he thinks it's a good drug with a lot of potential.
"What's noteworthy here is that the drug shows efficacy at a low side-effect
profile," Monane said.
Monane rates Telik a strong buy and doesn't own shares. There is an investment
banking relationship.
Asked if the company would be interested in finding a bigger company to buy
it, Telik's Brown implied that there's a "closed" sign on the door.
"We have great expertise and know what to do," Brown said. "We have enough
capital to get this to market."

-By Daniel Rosenberg