CytRx to Increase Patient Enrollment in INNO-206 Phase Ib/II Trial
Grant Zeng, CFA
Early today, CytRx Corporation (CYTR) announced that it is tripling the number of patients in its Phase Ib/II clinical trial of INNO-206 at the dose planned for its Phase IIb trial for the treatment of advanced soft tissue sarcomas.
As a reminder, the Phase Ib/II trial was originally called Phase Ib trial, which is being conducted at the Sarcoma Oncology Center in Santa Monica, California, under the direction of Sant P. Chawla, M.D., F.R.A.C.P, a leading expert in sarcomas and sarcoma therapies.
The Phase Ib/II is an open-label safety and dose escalation clinical trial for patients with advanced solid tumors who have failed standard therapies. This trial is to determine the maximum tolerated dose (MTD) of INNO-206.
Six patients have already been treated at 350mg/m2, out of a total of 13 enrolled in the trial, and the Company now plans to add an additional 12 patients. Patients in the Phase Ib/II trial are receiving INNO-206 at 350mg/m2 every three weeks in six cycles. This dose delivers doxorubicin at levels 3½-times higher than the dose of doxorubicin planned for the Company’s Phase IIb trial control arm. To date, all patients in the Phase Ib/II trial administered INNO-206 at this dose level have shown impressive tolerability and nearly all are continuing in the trial.
CytRx plans to initiate a Phase IIb trial of INNO-206 in patients with advanced soft tissue sarcomas in the US, Latin America and Europe after the completion of the Phase Ib/II trial. INNO-206 vs doxorubicin will be administered in the enrolled patients who are ineligible for surgery. The Phase IIb trial is slated to start by year end. It will be a randomized trial comparing INNO-206 versus doxorubicin in a 99 patient study with a 2:1 randomization.
Doxorubicin is currently the only FDA-approved drug on the market as a treatment for soft tissue sarcoma and is a standard chemotherapy for a variety of other cancers. It is used either alone or in combination with other chemotherapy agents. Dose levels of doxorubicin are limited due to its toxicity. INNO-206 is a novel conjugate of doxorubicin that binds covalently to albumin, and is circulated throughout the body. INNO-206 is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues.
On July 6, 2011, CytRx announced positive interim Phase Ib clinical trial results of INNO-206 in soft tissue sarcoma patients. INNO-206 is delivering doxorubicin safely at doses over 4 times higher than the standard doxorubicin dose in the Company’s open-label Phase Ib safety and dose escalation clinical trial.
The safety profile of INNO-206 is impressive as demonstrated in the Phase Ib trial. It has never been possible to safely raise the dose of a chemotherapy agent this much. The ability to administer dramatically higher doses of doxorubicin with INNO-206 could represent a major breakthrough in the treatment of various cancers in which doxorubicin is an important component of chemotherapy regimens.
On July 05, 2011, INNO-206 has been granted an orphan drug designation for the treatment of patients with soft tissue sarcomas.
We are impressed by the safety profile of INNO-206 so far. These initial safety and tolerability results indicate that INNO-206 could safely deliver more drugs directly to the tumor, which could increase efficacy.
We have an Outperform rating on CYTR with a price target of $1.60.
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