Fri, Jul. 29, 9:19 AM
Thu, Jul. 14, 7:01 PM
- Nano cap CytRx (NASDAQ:CYTR) slumps 22% after hours on robust volume in response to its announcement of a proposed equity offering of stock and one-year warrants. Prices, volumes and terms have yet to be announced.
- Net proceeds will fund working capital and general corporate purposes.
- Update: On July 15, the company announced that the offering is 28.6M shares of common stock at $0.70 per share plus immediately exercisable one-year warrants to purchase up to 28.6M shares of stock at $0.70. Closing date is July 20.
Tue, Jul. 12, 12:46 PM
Tue, Jul. 12, 11:01 AM
Tue, Jul. 12, 9:24 AM
Mon, Jul. 11, 4:31 PM
- Micro cap CytRx (NASDAQ:CYTR) craters 56% after hours on increased volume in response to its announcement of results from a Phase 3 clinical trial assessing lead product candidate aldoxorubicin compared to investigator's choice of therapy in patients with relapsed/refractory soft tissue sarcoma (STS).
- The primary endpoint was progression-free survival (PFS) at month 24, which the study failed to show a significant difference between aldoxorubicin and investigator's choice of therapy (4.17 months versus 4.04 months). According to the company, the analysis did not provide for sufficient follow-up for nearly 2/3 of patients who entered the Phase 3 study after the partial clinical hold was resolved and enrollment resumed. The partial hold was instituted by the FDA in November 2014 after a patient died who received aldoxorubicin. The net result was almost 50% of all study participants were excluded from the PFS evaluation. The company expects to conduct a second analysis that will include longer follow-up data in Q4. It also intends to hold an end-of-Phase 3 meeting with the FDA to review the results.
- On the plus side, objective response rate and disease control rate both favored aldoxorubicin over investigator's choice, including patients previously treated with doxorubicin.
- Updated results will be presented at an upcoming medical conference.
- Management will host a conference call today at 5:00 pm ET to discuss the results.
- Previously: CytRx off premarket in response to FDA hold on aldoxorubicin trials (Nov. 18, 2014)
Tue, May 31, 11:00 AM
Tue, May 10, 9:16 AM
Tue, May 10, 9:06 AM
- Micro cap CytRx (NASDAQ:CYTR) slumps 8% premarket on increased volume in response to a report published this morning by TheStreet's Adam Feuerstein. He says the company's Phase 3 clinical trial assessing lead product candidate aldoxorubicin for the second-line treatment of soft tissue sarcoma (STS) will likely fail considering its similarity to doxorubicin, an older chemo drug that doesn't work well against STS. The release of top-line data is expected next month.
- The bulk of Mr. Feuerstein's pessimism is based on his take of an earlier Phase 2b study that showed treatment with aldoxorubicin doubled progression-free survival compared to doxorubicin. On closer inspection, however, the difference appeared to be due to the early termination of doxorubicin in sarcoma patients which reduced PFS and response rate to lower-than-expected levels. PFS for aldoxorubicin was comparable to earlier studies of doxorubicin so had patients been maintained on therapy, the difference in PFS would likely have been modest, certainly shy of statistical significance.
- He also cites Ziopharm's (NASDAQ:ZIOP) failure with palifosfamide and Threshold Pharmaceuticals' (NASDAQ:THLD) failure with a similar compound called evofosfamide.
- The value proposition of aldoxorubicin is greater efficacy compared to doxorubicin by virtue of its linker molecule that binds to albumin. This supposedly drives greater uptake in the tumor which enables higher dosing without the collateral damage to healthy tissue.
- Previously: CytRx hits target number of progression events in late-stage aldoxorubicin study in soft tissue cancer; shares up 14% (April 4)
Mon, Apr. 4, 3:07 PM
- CytRx (CYTR +14.2%) is up on double normal volume in response to its announcement that it has reached the target number of progression events in its Phase 3 clinical trial assessing aldoxorubicin for the second-line treatment of soft tissue sarcomas (STS). Per the statistical analysis plan in the protocol, 191 events were required to trigger the analysis of the primary endpoint of progression-free survival. A contracted radiology group reviewed and verified the events and will analyze the scans.
- If all goes well, the company intends to initiate its rolling New Drug Application (NDA) by year end. Barring unforeseen delays, market launch for the indication should commence sometime in H2 2017.
- Aldoxorubicin is a conjugate of the chemo agent doxorubicin and an acid-sensitive linker. The formulation improves efficacy and reduces toxicity.
- STS, a cancer that occurs in the soft tissues of the body (e.g., muscle, fat, blood vessels), strikes more than 40K Americans and Europeans each year resulting in 13K deaths.
- Now read What's To Like About CytRx's Brain Cancer Data?
- Update: In a regulatory filing, the company announced that top-line data on the PFS endpoint will be reported next month (July).
Sep. 21, 2015, 9:19 AM
Jul. 21, 2015, 12:45 PM
Jul. 21, 2015, 9:15 AM
May 21, 2015, 9:16 AM
May 4, 2015, 1:28 PM
- Micro cap CytRx (CYTR +25.9%) jumps on a 6x surge in volume in response to its announcement of interim results from two ongoing Phase 1b trials assessing the combinations of aldoxorubicin with either gemcitabine or ifosfamide in cancer patients. The combinations have been well tolerated and impressive tumor responses have been observed in patients with osteosarcoma (bone cancer) and a variety of soft tissue sarcomas.
- The company's aldoxorubicin candidate is a conjugate of the chemo agent and an acid-sensitive linker. This formulation reduces its toxicity and improves its efficacy.
May 4, 2015, 12:45 PM
CytRx Corp. operates as a biopharmaceutical research and development company specializing in oncology. It provides clinical development of aldoxorubicin oncology pipeline for the treatment of cancer. The company was founded on February 28, 1985 and is headquartered in Los Angeles, CA.
Country: United States