Hollis-Eden Pharmaceuticals (HEPH)

PRODUCTS IN DEVELOPMENT

We are currently focusing our development activities on two compounds from our proprietary series. Our lead clinical drug development candidates are TRIOLEX™ (HE3286), a next-generation compound currently in clinical trials for the treatment of metabolic disorders and ulcerative colitis and being prepared for clinical trials in rheumatoid arthritis and APOPTONE™ (HE3235), a next-generation compound selected for clinical development in cancer.

Each of these compounds is described in more detail below. In addition, we have an active research program focused on adrenal hormones that is identifying additional clinical candidates for a wide range of medical conditions.

PRODUCTS IN DEVELOPMENT

SIZE="1"> 

We are currently focusing our development activities on two compounds from our proprietary series. Our lead clinical drug
development candidates are TRIOLEX™ (HE3286), a next-generation compound currently in clinical trials for the treatment of metabolic disorders and ulcerative colitis and being prepared for clinical trials in rheumatoid arthritis and
APOPTONE™ (HE3235), a next-generation compound selected for clinical development in cancer.

PRODUCTS IN DEVELOPMENT

We are currently focusing our development activities on two compounds from our proprietary series. Our lead clinical drug development candidates are TRIOLEX™ (HE3286), a next-generation compound currently in clinical trials for the treatment of metabolic disorders and ulcerative colitis and being prepared for clinical trials in rheumatoid arthritis and APOPTONE™ (HE3235), a next-generation compound selected for clinical development in cancer.

Each of these compounds is described in more detail below. In addition, we have an active research program focused on adrenal hormones that is identifying additional clinical candidates for a wide range of medical conditions.

PRODUCTS IN DEVELOPMENT

SIZE="1"> 

We are currently focusing our development activities on two compounds from our proprietary series. Our lead clinical drug
development candidates are TRIOLEX™ (HE3286), a next-generation compound currently in clinical trials for the treatment of metabolic disorders and ulcerative colitis and being prepared for clinical trials in rheumatoid arthritis and
APOPTONE™ (HE3235), a next-generation compound selected for clinical development in cancer.

PRODUCTS IN DEVELOPMENT

We are currently focusing our development activities on our proprietary series of IRHs. We have already generated indications of activity in human clinical trials with two of these compounds, NEUMUNE and IMMUNITIN, and two other compounds, HE3286 and HE3235, have now been selected for clinical development. Each of these compounds is described in more detail below. In addition, we have an active research program focused on adrenal hormones that is identifying additional clinical candidates for a host of medical conditions.

In addition to the potential role for NEUMUNE in ARS, we believe there is also an opportunity for the compound in preventing or mitigating infections acquired in the healthcare setting. Numerous published preclinical studies indicate that NEUMUNE can significantly improve survival from lethal infections when administered prior to infectious challenge. While we have an open IND for the compound in this indication, in light of HHS’ cancellation of its RFP described above, we have made the strategic decision to curtail further development of NEUMUNE and will focus our resources on HE3286, HE3235 and follow-on oral compounds for indications that have well defined clinical paths and large, well-established markets. If Congressional intervention or procurement activities by the Department of Defense improve the opportunity for NEUMUNE in the very short term we may revisit this decision. We will also consider licensing or selling the compound to third parties for further development.

PRODUCTS IN DEVELOPMENT

We are currently focusing our development activities on our proprietary series of IRHs. NEUMUNE is being co-developed with the U.S. military for use in protecting the body from Acute Radiation Syndrome, or ARS. A number of IRHs have shown significant benefits in preclinical models of chemotherapy-induced immune suppression, and we intend to test one of these compounds in Phase I/II clinical trials in this indication. In the infectious disease area, IMMUNITIN has shown activity in Phase II clinical trials in malaria, HIV and AIDS, and in a number of preclinical tuberculosis models. Furthermore, given the anti-inflammatory and immune regulating effects seen with many of our IRHs, we are screening second-generation IRHs in preclinical models of autoimmune conditions, pulmonary diseases and metabolic disorders. In addition, PHOSPHONOL, a non-IRH candidate, is being evaluated for protection against DNA mutations from radiation exposure and chemotherapy treatment.

PRODUCTS IN DEVELOPMENT

We are currently focusing our development activities on a series of immune regulating hormones, as well as PHOSPHONOL, the compound recently obtained through the acquisition of CPC. NEUMUNE is being co-developed with the U.S. military for use in protecting the body from acute radiation injury. This compound is being developed pursuant to a new rule enacted by the U.S. Food and Drug Administration (FDA) under which approval may be granted on the basis of efficacy in animals and safety in humans. PHOSPHONOL is being developed to protect against the long-term effects of radiation injury and may be subject to the same rule. A number of IRHs have shown significant benefits in preclinical models of chemotherapy-induced immune suppression, and we intend to test one of these compounds in Phase I/II clinical trials in this indication. IMMUNITIN is our lead infectious disease compound and has shown activity in Phase II clinical trials in malaria, HIV and AIDS, and in a number of preclinical tuberculosis models. We are pursuing public/private partnerships with a number of organizations that may provide funding to allow us to conduct a Phase II/III clinical trial with IMMUNITIN in infectious disease. In addition, IMMUNITIN and other immune regulating hormones may be useful as countermeasures against a number of pathogens that could be used as biowarfare agents. In addition, given the anti-inflammatory and immune stimulating effects seen with many of our IRHs, we are screening new IRHs in preclinical models of autoimmune conditions.