Update on the PRI724 Trial and Other Trials

Posted by Heinz-Josef Lenz, MD on October 5th, 2010

Dr. Lenz

Because of the overwhelming response to my earlier post on PRI724, I wanted to clarify a little bit more about this trial and other trials available for patients with advanced colorectal cancer who have received all standard of care regimens including FOLFOX, FOLFIRI, Avastin and Erbitux (if they were wild-type KRAS).

Of course we will have PRI724. The reason we are so excited because it is the first in class to inhibit a pathway so essential for colon cancer stem cells.

The IND is filed at the FDA, which means we need to wait 30 days for the FDA to respond. If they have concerns, we need to answer them. When they agree, we will go ahead to get institutional review board (IRB) approval. We already have scientific approval from the Cancer Center Scientific Review. Once we have IRB approval we are ready to go.

In the first phase any solid tumor is eligible. However, phase I trials are heavily regulated, so patients need to meet eligibility criteria, which means almost normal function of renal, liver, blood etc. They have to be in reasonable shape (able to do their daily activities). We anticipate that this trial may open at the beginning of November. Read the rest of this entry »

Cancer Stem Cell Drug PRI724 IND filed September 17

Posted by Kate Murphy on September 24th, 2010
Dr. Michael Kahn and Dr. Heinz-Josef Lenz

Dr. Kahn and Dr. Lenz in Their Lab

I have shared with you in the past the efforts of Dr. Michael Kahn and myself to develop novel drugs which are completely different than the existing ones.

Even the smart drugs we have such as Avastin or Erbitux, which are monoclonal antibodies that attack important targets in cancer growth and progression, have disappointed,  particularly if you are not able to select the patients who benefit the most.

Why are they not more effective? Read the rest of this entry »

Clinical Trials with Novel Compounds from Germany

Posted by Heinz-Josef Lenz, MD on July 28th, 2009

I wanted to share with you another novel clinical trial using a compound targeting two receptors on tumor cells. Both receptors we know very well: one is HER2, the target for Herceptin, and the other one is EGFR, the target for Erbitux.

One compound targeting both receptors is on the market known as Tykerb® (lapatinib) which is approved for breast cancer patients in combination with Xeloda® (capecitabine). Read the rest of this entry »

Novel Therapeutics: We’re Getting Smarter About Who and With What to Treat

Posted by Heinz-Josef Lenz, MD on July 26th, 2009

You may have heard the very exciting data about patients with breast cancer who carry BRCA mutations. These mutations indicate a genetic predisposition for breast cancer.

The function of BRCA is DNA repair, very similar to the genes associated with familial colorectal cancer known as Lynch syndrome or HNPCC (hereditary nonpolyposis colon cancer) which are the DNA mismatch repair genes. Read the rest of this entry »

Clinical Trials: Hope and Future

Posted by Heinz-Josef Lenz, MD on January 14th, 2009

Last Thursday we saw a 32 year old female with metastatic rectal cancer who had received all the best therapies so far but her oncologist was running out of treatment options.

The patient was not ready to give up and was looking for other options from clinical trials. She contacted our center to get more information on a number of clinical trials. We met with her and her parents to discuss potential treatment possibilities for her. Read the rest of this entry »